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Study Evaluating Vabicaserin in Subjects With Schizophrenia

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00563706
Collaborator
(none)
199
Enrollment
33
Locations
3
Arms
6
Duration (Months)
6
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
199 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Jun 1, 2008
Actual Study Completion Date :
Jun 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: vabicaserin
This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
Active Comparator: 2

4mg/day

Drug: risperidone
Placebo Comparator: 3

matching placebo

Other: placebo

Outcome Measures

Primary Outcome Measures

  1. Positive and Negative Symptom Scale (PANSS) Total Score at Baseline [Baseline]

    PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

  2. Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28 [Baseline, Day 28]

    PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

Secondary Outcome Measures

  1. Positive and Negative Symptom Scale (PANSS) Positive Subscale Score [Baseline, Day 7, 14, 21, 28]

    PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.

  2. Positive and Negative Symptom Scale (PANSS) Negative Subscale Score [Baseline, Day 7, 14, 21, 28]

    PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.

  3. Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score [Baseline, Day 7, 14, 21, 28]

    General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.

  4. Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score [Baseline, Day 7, 14, 21, 28]

    Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.

  5. Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score [Baseline, Day 7, 14, 21, 28]

    Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

  6. Clinical Global Impression - Severity (CGI-S) Score [Baseline, Day 7, 14, 21, 28]

    CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).

  7. Clinical Global Impression - Improvement (CGI-I) Score [Day 7, 14, 21, 28]

    CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).

  8. Calgary Depression Scale for Schizophrenia (CDSS) Score [Baseline, Day 7, 14, 21, 28]

    CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Generally healthy, men and women, aged 18 to 65.

  • Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.

  • Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.

Exclusion Criteria:

  • Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).

  • Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).

  • Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Little Rock Arkansas United States 72201
2 Pfizer Investigational Site Cerritos California United States 90703
3 Pfizer Investigational Site Escondido California United States 92025
4 Pfizer Investigational Site Garden Grove California United States 92845
5 Pfizer Investigational Site Glendale California United States 91206
6 Pfizer Investigational Site San Diego California United States 92103
7 Pfizer Investigational Site San Diego California United States 92123
8 Pfizer Investigational Site Torrance California United States 90502
9 Pfizer Investigational Site Washington District of Columbia United States 20016
10 Pfizer Investigational Site Aventura Florida United States 33180
11 Pfizer Investigational Site Hollywood Florida United States 33021
12 Pfizer Investigational Site Kissimmee Florida United States 34741
13 Pfizer Investigational Site Hoffman Estates Illinois United States 60169
14 Pfizer Investigational Site Indianapolis Indiana United States 46222
15 Pfizer Investigational Site Lake Charles Louisiana United States 70601
16 Pfizer Investigational Site Baltimore Maryland United States 21202
17 Pfizer Investigational Site Rockville Maryland United States 20850
18 Pfizer Investigational Site Hamilton New Jersey United States 08619
19 Pfizer Investigational Site Willingboro New Jersey United States 08046
20 Pfizer Investigational Site Cedarhurst New York United States 11516
21 Pfizer Investigational Site Holliswood New York United States 11423
22 Pfizer Investigational Site New York New York United States 10032
23 Pfizer Investigational Site Butner North Carolina United States 27509
24 Pfizer Investigational Site Oklahoma City Oklahoma United States 73103
25 Pfizer Investigational Site Philadelphia Pennsylvania United States 19131
26 Pfizer Investigational Site Austin Texas United States 78754
27 Pfizer Investigational Site Austin Texas United States 78756
28 Pfizer Investigational Site Bellaire Texas United States 77008
29 Pfizer Investigational Site DeSoto Texas United States 75115
30 Pfizer Investigational Site Houston Texas United States 77008
31 Pfizer Investigational Site Arlington Virginia United States 22201
32 Pfizer Investigational Site Portsmouth Virginia United States 23707
33 Pfizer Investigational Site Kingston Ontario Canada K7L 4X3

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00563706
Other Study ID Numbers:
  • 3153A1-2203
  • B1911032
First Posted:
Nov 26, 2007
Last Update Posted:
Mar 20, 2014
Last Verified:
Feb 1, 2014
Additional relevant MeSH terms:
Schizophrenia
Risperidone

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail A total of 204 participants were randomized, of which 202 participants received at least 1 dose of double-blind test article.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Period Title: DB Treatment Period (Day 1 up to Day 28)
STARTED 37 18 8 19 16 19 12 30 43
COMPLETED 20 13 3 9 11 14 9 16 32
NOT COMPLETED 17 5 5 10 5 5 3 14 11
Period Title: DB Treatment Period (Day 1 up to Day 28)
STARTED 20 13 3 9 11 14 9 16 32
COMPLETED 20 13 3 9 11 14 9 16 32
NOT COMPLETED 0 0 0 0 0 0 0 0 0

Baseline Characteristics

Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone Total
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase. Total of all reporting groups
Overall Participants 37 18 8 19 16 19 12 30 43 202
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
42.05
(9.88)
43.22
(10.17)
41.25
(4.89)
40.53
(11.43)
42.94
(8.27)
40.74
(10.29)
38.17
(9.73)
43.60
(9.25)
42.72
(9.93)
42.07
(9.67)
Sex: Female, Male (Count of Participants)
Female
8
21.6%
4
22.2%
1
12.5%
4
21.1%
5
31.3%
3
15.8%
0
0%
6
20%
10
23.3%
41
20.3%
Male
29
78.4%
14
77.8%
7
87.5%
15
78.9%
11
68.8%
16
84.2%
12
100%
24
80%
33
76.7%
161
79.7%

Outcome Measures

1. Primary Outcome
Title Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
Description PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 35 17 8 18 16 18 12 28 42
Mean (Standard Deviation) [units on a scale]
94.74
(11.18)
94.24
(8.42)
96.88
(14.54)
101.33
(12.97)
93.06
(8.84)
94.39
(8.73)
92.83
(10.25)
95.54
(12.46)
91.43
(10.83)
2. Primary Outcome
Title Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
Description PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Time Frame Baseline, Day 28

Outcome Measure Data

Analysis Population Description
mITT population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score. Here "N" (number of participants analyzed) signifies those participants who were evaluable for this measure.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 21 13 3 10 11 14 9 17 32
Least Squares Mean (Standard Error) [units on a scale]
-17.03
(3.59)
-4.72
(4.87)
-10.26
(8.35)
-5.41
(5.18)
-13.42
(5.17)
-6.13
(4.80)
-13.84
(5.93)
-7.30
(4.09)
-15.59
(3.20)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Vabicaserin 50 mg
Comments Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.043
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter Least Squares (LS) Mean Difference
Estimated Value -12.30
Confidence Interval (2-Sided) 95%
-24.24 to -0.37
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Vabicaserin 100 mg
Comments Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.457
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -6.77
Confidence Interval (2-Sided) 95%
-24.70 to 11.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Vabicaserin 150 mg
Comments Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.067
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -11.61
Confidence Interval (2-Sided) 95%
-24.03 to 0.81
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Vabicaserin 200 mg
Comments Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.567
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.61
Confidence Interval (2-Sided) 95%
-16.02 to 8.80
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Vabicaserin 300 mg
Comments Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.070
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -10.90
Confidence Interval (2-Sided) 95%
-22.71 to 0.92
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Vabicaserin 400 mg
Comments Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.647
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -3.18
Confidence Interval (2-Sided) 95%
-16.87 to 10.50
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Vabicaserin 600 mg
Comments Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.075
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -9.73
Confidence Interval (2-Sided) 95%
-20.46 to 1.00
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Risperidone
Comments Mixed effects model was used to assess the treatment effects with change in PANSS total score from baseline as response variable, treatment, visit, and treatment by visit as fixed factors and baseline value as a covariate.
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value 0.765
Comments
Method Mixed Models Analysis
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value -1.44
Confidence Interval (2-Sided) 95%
-10.92 to 8.04
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title Positive and Negative Symptom Scale (PANSS) Positive Subscale Score
Description PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.
Time Frame Baseline, Day 7, 14, 21, 28

Outcome Measure Data

Analysis Population Description
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 0 0 0 0 0 0 0 0 0
4. Secondary Outcome
Title Positive and Negative Symptom Scale (PANSS) Negative Subscale Score
Description PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.
Time Frame Baseline, Day 7, 14, 21, 28

Outcome Measure Data

Analysis Population Description
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 0 0 0 0 0 0 0 0 0
5. Secondary Outcome
Title Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score
Description General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.
Time Frame Baseline, Day 7, 14, 21, 28

Outcome Measure Data

Analysis Population Description
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 0 0 0 0 0 0 0 0 0
6. Secondary Outcome
Title Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score
Description Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.
Time Frame Baseline, Day 7, 14, 21, 28

Outcome Measure Data

Analysis Population Description
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 0 0 0 0 0 0 0 0 0
7. Secondary Outcome
Title Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score
Description Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.
Time Frame Baseline, Day 7, 14, 21, 28

Outcome Measure Data

Analysis Population Description
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 0 0 0 0 0 0 0 0 0
8. Secondary Outcome
Title Clinical Global Impression - Severity (CGI-S) Score
Description CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Time Frame Baseline, Day 7, 14, 21, 28

Outcome Measure Data

Analysis Population Description
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 0 0 0 0 0 0 0 0 0
9. Secondary Outcome
Title Clinical Global Impression - Improvement (CGI-I) Score
Description CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).
Time Frame Day 7, 14, 21, 28

Outcome Measure Data

Analysis Population Description
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 0 0 0 0 0 0 0 0 0
10. Secondary Outcome
Title Calgary Depression Scale for Schizophrenia (CDSS) Score
Description CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.
Time Frame Baseline, Day 7, 14, 21, 28

Outcome Measure Data

Analysis Population Description
Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
Measure Participants 0 0 0 0 0 0 0 0 0

Adverse Events

Time Frame
Adverse Event Reporting Description The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Arm/Group Description Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase. Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase. Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase. One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
All Cause Mortality
Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 4/37 (10.8%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 2/12 (16.7%) 2/30 (6.7%) 3/43 (7%)
Infections and infestations
Respiratory tract infection 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Psychiatric disorders
Agitation 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Depression 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Homicidal ideation 2/37 (5.4%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Intentional self-injury 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Psychotic disorder 0/37 (0%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 1/30 (3.3%) 0/43 (0%)
Schizophrenia 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Schizophrenia, undifferentiated type 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Suicidal ideation 2/37 (5.4%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 1/43 (2.3%)
Respiratory, thoracic and mediastinal disorders
Asthma 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Vascular disorders
Hypotension 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 0/30 (0%) 0/43 (0%)
Other (Not Including Serious) Adverse Events
Placebo Vabicaserin 50 mg Vabicaserin 100 mg Vabicaserin 150 mg Vabicaserin 200 mg Vabicaserin 300 mg Vabicaserin 400 mg Vabicaserin 600 mg Risperidone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 28/37 (75.7%) 12/18 (66.7%) 6/8 (75%) 11/19 (57.9%) 13/16 (81.3%) 13/19 (68.4%) 10/12 (83.3%) 23/30 (76.7%) 35/43 (81.4%)
Blood and lymphatic system disorders
Neutropenia 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Cardiac disorders
Tachycardia 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 2/43 (4.7%)
Ear and labyrinth disorders
Ear discomfort 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Tinnitus 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Eye disorders
Conjunctivitis 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 2/16 (12.5%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Dry eye 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Gaze palsy 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Photophobia 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Vision blurred 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 1/43 (2.3%)
Gastrointestinal disorders
Abdominal discomfort 1/37 (2.7%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 2/19 (10.5%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Abdominal distension 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Abdominal pain 2/37 (5.4%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Abdominal pain upper 2/37 (5.4%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 1/30 (3.3%) 0/43 (0%)
Anal pruritus 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Constipation 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 1/19 (5.3%) 1/16 (6.3%) 2/19 (10.5%) 0/12 (0%) 4/30 (13.3%) 3/43 (7%)
Diarrhoea 5/37 (13.5%) 2/18 (11.1%) 0/8 (0%) 1/19 (5.3%) 2/16 (12.5%) 1/19 (5.3%) 0/12 (0%) 2/30 (6.7%) 3/43 (7%)
Dry mouth 1/37 (2.7%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 3/43 (7%)
Dyspepsia 2/37 (5.4%) 1/18 (5.6%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 2/30 (6.7%) 2/43 (4.7%)
Dysphagia 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Gastrooesophageal reflux disease 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 0/30 (0%) 0/43 (0%)
Haemorrhoids 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Nausea 3/37 (8.1%) 1/18 (5.6%) 1/8 (12.5%) 2/19 (10.5%) 1/16 (6.3%) 1/19 (5.3%) 2/12 (16.7%) 3/30 (10%) 4/43 (9.3%)
Oral disorder 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Salivary hypersecretion 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Stomach discomfort 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 1/19 (5.3%) 0/12 (0%) 1/30 (3.3%) 3/43 (7%)
Toothache 3/37 (8.1%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 2/30 (6.7%) 4/43 (9.3%)
Vomiting 2/37 (5.4%) 2/18 (11.1%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 2/12 (16.7%) 3/30 (10%) 0/43 (0%)
General disorders
Asthenia 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Gait disturbance 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Pain 2/37 (5.4%) 1/18 (5.6%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Pitting oedema 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Pyrexia 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 1/30 (3.3%) 1/43 (2.3%)
Sluggishness 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Immune system disorders
Seasonal allergy 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 0/30 (0%) 0/43 (0%)
Infections and infestations
Folliculitis 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Localised infection 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Nasopharyngitis 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Pharyngitis 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Respiratory tract infection 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Sexually transmitted disease 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Tooth infection 0/37 (0%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Upper respiratory tract infection 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 0/30 (0%) 0/43 (0%)
Urinary tract infection 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 2/30 (6.7%) 1/43 (2.3%)
Injury, poisoning and procedural complications
Arthropod bite 0/37 (0%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Fall 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Medical device complication 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Skin laceration 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Investigations
Activated partial thromboplastin time prolonged 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Alanine aminotransferase increased 1/37 (2.7%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 2/43 (4.7%)
Aspartate aminotransferase increased 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 1/43 (2.3%)
Blood creatinine increased 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Blood lactate dehydrogenase increased 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Blood uric acid increased 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Gamma-glutamyltransferase increased 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 2/16 (12.5%) 0/19 (0%) 0/12 (0%) 2/30 (6.7%) 1/43 (2.3%)
Hepatic enzyme increased 1/37 (2.7%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Liver function test abnormal 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Weight decreased 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Weight increased 1/37 (2.7%) 1/18 (5.6%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 1/19 (5.3%) 2/12 (16.7%) 0/30 (0%) 6/43 (14%)
Metabolism and nutrition disorders
Decreased appetite 2/37 (5.4%) 1/18 (5.6%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Increased appetite 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Back pain 2/37 (5.4%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 2/43 (4.7%)
Musculoskeletal pain 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 3/43 (7%)
Musculoskeletal stiffness 2/37 (5.4%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 1/30 (3.3%) 2/43 (4.7%)
Neck pain 2/37 (5.4%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Pain in extremity 1/37 (2.7%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 2/43 (4.7%)
Sensation of heaviness 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Nervous system disorders
Akathisia 2/37 (5.4%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 3/43 (7%)
Choreoathetosis 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Dizziness 2/37 (5.4%) 1/18 (5.6%) 1/8 (12.5%) 0/19 (0%) 2/16 (12.5%) 0/19 (0%) 1/12 (8.3%) 5/30 (16.7%) 3/43 (7%)
Drooling 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Dyskinesia 0/37 (0%) 2/18 (11.1%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Extrapyramidal disorder 3/37 (8.1%) 1/18 (5.6%) 1/8 (12.5%) 3/19 (15.8%) 2/16 (12.5%) 0/19 (0%) 0/12 (0%) 2/30 (6.7%) 3/43 (7%)
Headache 5/37 (13.5%) 1/18 (5.6%) 1/8 (12.5%) 1/19 (5.3%) 1/16 (6.3%) 1/19 (5.3%) 1/12 (8.3%) 3/30 (10%) 4/43 (9.3%)
Lethargy 1/37 (2.7%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 0/30 (0%) 0/43 (0%)
Sedation 2/37 (5.4%) 1/18 (5.6%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 2/43 (4.7%)
Sinus headache 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Somnolence 1/37 (2.7%) 0/18 (0%) 1/8 (12.5%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 4/43 (9.3%)
Tardive dyskinesia 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Tremor 0/37 (0%) 1/18 (5.6%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 2/30 (6.7%) 1/43 (2.3%)
Psychiatric disorders
Agitation 3/37 (8.1%) 1/18 (5.6%) 1/8 (12.5%) 1/19 (5.3%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 1/30 (3.3%) 1/43 (2.3%)
Anxiety 0/37 (0%) 2/18 (11.1%) 0/8 (0%) 0/19 (0%) 2/16 (12.5%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 2/43 (4.7%)
Bruxism 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Insomnia 1/37 (2.7%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 1/19 (5.3%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Nightmare 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 1/30 (3.3%) 0/43 (0%)
Paranoia 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)
Psychotic disorder 1/37 (2.7%) 1/18 (5.6%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 1/12 (8.3%) 2/30 (6.7%) 0/43 (0%)
Restlessness 0/37 (0%) 0/18 (0%) 0/8 (0%) 2/19 (10.5%) 0/16 (0%) 2/19 (10.5%) 1/12 (8.3%) 0/30 (0%) 1/43 (2.3%)
Schizophrenia 0/37 (0%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Renal and urinary disorders
Pollakiuria 1/37 (2.7%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Urinary incontinence 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Reproductive system and breast disorders
Galactorrhoea 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Respiratory, thoracic and mediastinal disorders
Cough 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 1/19 (5.3%) 1/16 (6.3%) 0/19 (0%) 1/12 (8.3%) 0/30 (0%) 1/43 (2.3%)
Nasal congestion 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 1/19 (5.3%) 0/12 (0%) 1/30 (3.3%) 2/43 (4.7%)
Pharyngolaryngeal pain 2/37 (5.4%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 1/43 (2.3%)
Productive cough 0/37 (0%) 0/18 (0%) 0/8 (0%) 1/19 (5.3%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Pulmonary congestion 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 1/43 (2.3%)
Rhinitis allergic 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Throat irritation 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Skin and subcutaneous tissue disorders
Dermatitis 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 0/43 (0%)
Pruritus 0/37 (0%) 1/18 (5.6%) 0/8 (0%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 3/43 (7%)
Skin lesion 0/37 (0%) 0/18 (0%) 1/8 (12.5%) 0/19 (0%) 0/16 (0%) 0/19 (0%) 0/12 (0%) 0/30 (0%) 2/43 (4.7%)
Vascular disorders
Orthostatic hypotension 0/37 (0%) 0/18 (0%) 0/8 (0%) 0/19 (0%) 1/16 (6.3%) 0/19 (0%) 0/12 (0%) 1/30 (3.3%) 0/43 (0%)

Limitations/Caveats

Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00563706
Other Study ID Numbers:
  • 3153A1-2203
  • B1911032
First Posted:
Nov 26, 2007
Last Update Posted:
Mar 20, 2014
Last Verified:
Feb 1, 2014