PRISMA-3_OLE: Study to Evaluate the Efficacy and Safety of Risperidone ISM® in Patients With Acute Schizophrenia: Open Label Extension

Sponsor
Rovi Pharmaceuticals Laboratories (Industry)
Overall Status
Completed
CT.gov ID
NCT03870880
Collaborator
(none)
215
24
2
28.5
9
0.3

Study Details

Study Description

Brief Summary

This is the long-term open label extension (OLE) of the study PRISMA-3 (NCT03160521). Those patients who complete participation in the main segment of the study (double blind) together with other clinically stable not previously enrolled (de novo patients) may opt to participate in this extension segment, where they will receive active Risperidone ISM® (75 mg or 100 mg)under open-label conditions every four weeks for approximately 12 months.

Condition or Disease Intervention/Treatment Phase
  • Drug: Risperidone ISM 75 mg
  • Drug: Risperidone ISM 100 mg
Phase 3

Detailed Description

Patients who have completed planned participation in the double-blind segment of the study PRISMA-3 (NCT03160521) through to the end of the treatment period, may be eligible to enter into this optional long-term extension segment of the study. During this extension, open-label Risperidone ISM® (i.e., either 75 or 100 mg) will be administered to all participating patients once every 4 weeks for approximately 12 months. Patients who enter into the extension segment of the study will begin participation in the extension segment immediately upon completion of the end-of-treatment visit assessments and procedures.

In addition to patients continuing from the double-blind segment of the study PRISMA-3 (rollover patients), clinically stable patients not previously enrolled in the study (de novo patients) may be eligible to enter the long-term extension segment of the study. These patients will be evaluated for eligibility at a screening visit and, if eligible, will be allocated to receive either 75 or 100 mg Risperidone ISM every 4 weeks for approximately 12 months.

Approximately 100 de novo patients are planned to be enrolled in the extension segment of the study, in addition to rollover patients.

Study Design

Study Type:
Interventional
Actual Enrollment :
215 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
It is an open label extension
Primary Purpose:
Treatment
Official Title:
Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Injections of Risperidone ISM® in Patients With Acute Exacerbation of Schizophrenia: Open Label Extension (PRISMA-3_OLE)
Actual Study Start Date :
Aug 25, 2017
Actual Primary Completion Date :
Jan 8, 2020
Actual Study Completion Date :
Jan 8, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Risperidone ISM 75 mg

Patients assigned to this arm will receive 75 mg of Risperidone ISM during the open label extensión (OLE). Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients.

Drug: Risperidone ISM 75 mg
Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle.

Experimental: Risperidone ISM 100 mg

Patients assigned to this arm will receive 100 mg of Risperidone ISM during the open label extensión (OLE). Patients enter the study as rollover patients from the study NCT03160521, along with newly enrolled de novo patients.

Drug: Risperidone ISM 100 mg
Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.

Outcome Measures

Primary Outcome Measures

  1. PANSS Total Score Mean Change From Baseline to Endpoint [Baseline and Day 365 (or the last post-baseline assessment)]

    The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicates improvements in symptoms whereas higher scores mean a worse outcome. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.

Other Outcome Measures

  1. PANSS Positive Subscale Mean Change From Baseline to Endpoint [Baseline and Day 365 (or the last post-baseline assessment)]

    The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.

  2. PANSS Negative Subscale Mean Change From Baseline to Endpoint [Baseline and Day 365 (or the last post-baseline assessment)]

    The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.

  3. PANSS General Psychopathology Subscale Mean Change From Baseline to Endpoint [Baseline and Day 365 (or the last post-baseline assessment)]

    The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The general psychopathology scale consists of 16 items which measure somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. PANSS General Psychopathology Subscale Score ranges from 16 (absence of symptoms) to 112 (extremely severe symptoms). Endpoint is defined as study day 356 or the last post-baseline assessment if early discontinuation.

  4. Clinician Global Impression - Severity (CGI-S) Total Score Mean Change From Baseline to Endpoint [Baseline and Day 365 (or the last post-baseline assessment)]

    The Clinician Global Impression - Severity (CGI-S) score is a 7-point clinician-rated scale for assessing the global severity of the illness. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness whereas higher scores mean a worse outcome. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.

  5. Clinician Global Impression - Improvement (CGI-I) Score [Day 365 (or the last post-baseline assessment)]

    The Clinical Global Impression - Improvement (CGI-I) is a single 7-point rating score total improvement, regardless of whether or not the change it is due entirely to drug treatment. Raters select one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are: 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; or 7, Very much worse. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.

  6. Overall Response Rate at Endpoint [Day 365 (or the last post-baseline assessment)]

    Overall response was defined as either PANSS total score ≥ 30% decrease from baseline, or CGI-I score of 2 (much improved) or 1 (very much improved). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.

  7. Relapse Rate [Day 365 (or the last post-baseline assessment)]

    Relapse was defined as either increase from baseline in PANSS total score ≥30% or rehospitalization for psychotic symptoms or use of adjunctive antipsychotic medication after stabilization.

  8. Patients With Treatment Emergent Adverse Events (TEAEs) [Up to Day 365 (or the last post-baseline assessment)]

    An Adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study (from the informed consent form signature) or, if present at screening, worsens during the study, regardless of the suspected cause of the event. The treatment-emergent AEs (TEAEs) are defined as events that are newly occurring or worsening from the time of the first dose of the intramuscular study drug.

  9. TEAEs Leading to Study Drug Discontinuation [Up to Day 365 (or the last post-baseline assessment)]

    TEAEs which resulted in permanent study drug discontinuation

  10. Patients With Treatment-related TEAEs [Up to Day 365 (or the last post-baseline assessment)]

    An Adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study (from the informed consent form signature) or, if present at screening, worsens during the study, regardless of the suspected cause of the event. The treatment-emergent AEs (TEAEs) are defined as events that are newly occurring or worsening from the time of the first dose of the intramuscular study drug. The temporal relationship of the AE with the investigational medicinal product makes causality possible, and the AE cannot be due to another cause such as other drugs, a surgical intervention, or an underlying disease

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

Participation in the open-label extension segment of the study PRISMA-3 is optional, and patients who complete participation in the main segment of the study (double blind segment of PRISMA-3, NCT03160521) may opt to not participate. Patients who are interested in participating must meet all eligibility criteria in order to enter into the extension segment.

Inclusion Criteria (Rollover patients):

To be eligible for entry into the extension segment of the study PRISMA-3, a patient must meet all of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the main part of the study):

  1. Has completed scheduled participation in the double blind segment of the study PRISMA-3, through to the end of the treatment period and including the end-of-treatment visit

  2. Continues to require long-term treatment with an antipsychotic medication, in the opinion of the investigator

  3. Continues to meet contraceptive requirements of the study PRISMA-3

  4. Is willing to participate in the extension segment of the study and remains capable of providing informed consent

  1. A signed informed consent form must be provided before any study assessments are performed for the extension segment
  1. Continues to reside in a stable living situation, in the opinion of the investigator

  2. Continues to have an identified reliable informant, in the opinion of the investigator

Exclusion Criteria (Rollover patients):

An individual who meets any of the following criteria at the extension baseline time point (immediately upon completion of the end-of-treatment visit assessments and procedures for the double blind segment PRISMA-3) will not be permitted to enter into this extension segment of the study PRISMA-3:

  1. Missed more than 1 scheduled study visit during participation in the double blind segment of study PRISMA-3

  2. Had an abnormal clinical laboratory value, vital sign, or ECG finding during participation in the main part of the study that, in the opinion of the investigator, was clinically relevant, related to study drug, and would compromise the well-being of the patient in the extension segment

  3. Had a clinically significant or unstable medical illness/condition/disorder during the main part of the study that would be anticipated, in the investigator's opinion, to potentially compromise patient safety in the extension segment

  4. Is taking or is anticipated to require any prohibited concomitant medication

  5. Pregnant, lactating, or breastfeeding

  6. Any contraindication for continued IM injections (e.g., treatment with anticoagulant)

  7. Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections

  8. Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons

Inclusion Criteria (De Novo Patients):
  1. Capable of providing informed consent

  2. Age ≥ 18 and ≤ 65 years old

  3. On a stable dose of oral risperidone from 4 to 6 mg daily as maintenance therapy for at least the last 4 weeks prior/before screening/baseline and would potentially benefit from conversion to an extended release injectable, in the opinion of the investigator

  4. Current diagnosis of schizophrenia, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria that is clinically stable as evidenced by:

  • No hospitalizations for acute exacerbations of schizophrenia and psychiatrically stable without significant symptom exacerbation over the last 3 months before screening based on the investigator's judgment

  • PANSS total score < 70 at screening

  • CGI-S score of ≤ 3 (mild) at screening

  1. Has previously had a clinically significant beneficial response (improvement in schizophrenia symptoms), as determined by the investigator, to treatment with an antipsychotic medication other than clozapine

  2. At least 2 years elapsed since initial onset of active-phase schizophrenia symptoms

  3. Subject is outpatient; not hospitalized for worsening of schizophrenia within the last 3 months (hospitalization for social management within this time period is acceptable)

  4. Medically stable over the last month prior to screening based on the investigator's judgment

  5. BMI of 18.5 to 40.0 kg/m2 (inclusive) at screening

  6. Agrees to discontinue prohibited medications as applicable and as clinically indicated according to investigator instructions

  7. Dosages of all permitted medications are considered to have been stable (with the exception of medication to be used on an as-needed basis) for ≥ 2 weeks prior to the baseline visit and to remain stable during participation in this study

  8. Resides in a stable living situation, in the opinion of the investigator

  9. Has an identified reliable informant, in the opinion of the investigator

  10. Meets the contraceptive criteria stablished in the study

  11. Agrees not to post any personal medical data related to the study or information related to the study on any website or social media site during the study duration.

Exclusion Criteria (De Novo Patients):
  1. History of proven inadequate clinical response to treatment with therapeutic doses (with good compliance) of risperidone or paliperidone

  2. History of treatment resistance, defined as failure to respond to 2 discrete adequate trials (≥ 4 weeks with an adequate dose) of 2 different antipsychotic medications; history of clozapine use (exception: use was not because of treatment resistance or refractory psychotic symptoms)

  3. Known or suspected intolerance of or allergy or hypersensitivity to risperidone, paliperidone, or any of the excipients in the IM formulations of these

  4. History of neuroleptic malignant syndrome, clinically significant tardive dyskinesia or tardive dystonia

  5. History of any other medical condition that is considered to pose any unjustifiable risk or interfere with study assessments

  6. Clinically significant extrapyramidal symptoms at screening or baseline

  7. At significant risk of suicidal, homicidal or violent ideation or behavior, by history or as clinically assessed by the investigator at screening visit

  8. Answer of "yes" on item 4 or on item 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) (ideation) with the most recent episode occurring within the past 2 months, or answer "yes" to any of the 5 items (behavior) with an episode occurring within the last year

  9. Current diagnosis or a history of substance use disorder according to DSM-5 criteria within 6 months prior to the screening visit (with the exception of tobacco, mild cannabis, or mild alcohol use disorder) or a positive drug screen test (with the exception of cannabis) verified by repeat testing

  10. Lifetime history of diagnosis of schizoaffective disorder or bipolar disorder

  11. Clinically significant comorbid neuropsychiatric disorders

  12. Clinically significant or unstable medical illness/condition/disorder that would be anticipated, in the investigator's opinion, to potentially compromise patient safety or adversely affect the evaluation of efficacy

  13. Laboratory abnormality that, in the opinion of the investigator, would compromise the well-being of the patient, or any of the following laboratory abnormalities at screening or baseline

  14. Pregnant, lactating, or breastfeeding

  15. Inadequate gluteal or deltoid musculature or excessive fat, as determined by the investigator, that would interfere with IM study drug injections

  16. Any contraindication for IM injections

  17. Receipt of any long-acting antipsychotic medication by IM injection within 60 days before screening

  18. Current involuntary hospitalization or incarceration

  19. Hospitalized for more than 30 days during the 90 days before screening

  20. Participation in another clinical study in which the patient received an experimental or investigational drug or agent within 6 months before screening

  21. Participation in a clinical study with Risperidone ISM within 12 months before screening

  22. Study site personnel and/or persons employed by the investigator or study site or is an immediate family member of such persons

  23. Patients taking or anticipated to require any prohibited concomitant medication

Contacts and Locations

Locations

Site City State Country Postal Code
1 Woodland Research Northwest Rogers Arkansas United States 72758
2 Collaborative Neuroscience Network, LLC. Garden Grove California United States 92845
3 Apostle Clinical Trials Inc. Long Beach California United States 90813
4 NRC Research Institute Orange California United States 92868
5 CNRI-Los Angeles LLC Pico Rivera California United States 90660
6 CNRI-San Diego San Diego California United States 92112
7 Galiz Research Hialeah Florida United States 33016
8 Innovative Clinical Research Inc. Hollywood Florida United States 33021
9 CBH Health LLC Gaithersburg Maryland United States 20877
10 Altea Research Institute Las Vegas Nevada United States 89102
11 Hassman Research Institute Berlin New Jersey United States 08009
12 Midwest Clinical Research Center Dayton Ohio United States 45417
13 InSite Clinical Research DeSoto Texas United States 75115
14 Regional Clinical Hospital n.a I.I. Mechnicov Dnipro Ukraine 49005
15 Kharkiv Regional Clinical Psychiatric Hospital Kharkiv Ukraine 61068
16 Public Healthcare Institution "Kharkiv Regional Clinical Psychiatric Hospital No. 3", Center of Urgent Psychiatry Kharkiv Ukraine 61068
17 Kherson Regional Psychiatric Hospital Kherson Ukraine 73488
18 Kiev City Psychiatric Hospital No. 2 Kiev Ukraine 02192
19 Kyiv Regional Medical Association "Psykhiatriya" in Kyiv Kiev Ukraine 04080
20 CI Lviv Regional Clinical Psychiatric Hospital. Department 20 Lviv Ukraine 79021
21 CI Lviv Regional Clinical Psychiatric Hospital. Department 25 Lviv Ukraine 79021
22 Odesa Regional Medical Centre of Mental Health Odesa Ukraine 65006
23 Maltsev Regional Clinical Psychiatric Ho Poltava Ukraine 36013
24 N.I. Pyrogov Vinnytsya Natl Medical University Vinnytsia Ukraine 21005

Sponsors and Collaborators

  • Rovi Pharmaceuticals Laboratories

Investigators

  • Principal Investigator: Robert Litman, CBH Health LLC
  • Principal Investigator: Yuriy Filts, CI Lviv Regional Clinical Psychiatric Hospital. Department 25

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT03870880
Other Study ID Numbers:
  • ROV-RISP-2016-01_OLE
First Posted:
Mar 12, 2019
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details Patients enter the study as rollover patients from the previous double-blind (DB) study (NCT03160521), along with newly enrolled de novo patients. Rollover patients received Risperidone ISM in the OLE study at the same dose as during the DB study (75 mg or 100 mg). Patients who received placebo in the DB were assigned to receive either Risperidone ISM 75 or 100 mg during the OLE. De novo patients received either Risperidone ISM 75 or 100 mg depending on the previous oral risperidone treatment.
Pre-assignment Detail
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone ISM 75mg/Risperidone ISM 75mg De Novo/Risperidone ISM 75mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
Period Title: Overall Study
STARTED 27 58 31 28 61 10
COMPLETED 21 43 26 20 44 7
NOT COMPLETED 6 15 5 8 17 3

Baseline Characteristics

Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone ISM 75mg/Risperidone ISM 75mg De Novo/Risperidone ISM 75mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg Total
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day. Total of all reporting groups
Overall Participants 27 58 31 28 61 10 215
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
38.7
(9.29)
40.9
(11.98)
37.0
(10.91)
38.4
(10.42)
40.3
(11.04)
35.5
(6.40)
39.3
(10.84)
Sex: Female, Male (Count of Participants)
Female
7
25.9%
20
34.5%
11
35.5%
17
60.7%
23
37.7%
6
60%
84
39.1%
Male
20
74.1%
38
65.5%
20
64.5%
11
39.3%
38
62.3%
4
40%
131
60.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
1
3.7%
5
8.6%
0
0%
2
7.1%
0
0%
0
0%
8
3.7%
Not Hispanic or Latino
26
96.3%
53
91.4%
31
100%
26
92.9%
61
100%
10
100%
207
96.3%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Asian
0
0%
1
1.7%
0
0%
0
0%
0
0%
0
0%
1
0.5%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Black or African American
5
18.5%
7
12.1%
0
0%
6
21.4%
14
23%
0
0%
32
14.9%
White
22
81.5%
50
86.2%
31
100%
22
78.6%
47
77%
10
100%
182
84.7%
More than one race
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Unknown or Not Reported
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
7
25.9%
11
19%
0
0%
6
21.4%
16
26.2%
0
0%
40
18.6%
Ukraine
20
74.1%
47
81%
31
100%
22
78.6%
45
73.8%
10
100%
175
81.4%
Body Mass Index (BMI) (Kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m^2]
27.53
(4.488)
26.52
(4.741)
25.28
(3.695)
27.65
(4.954)
27.53
(5.055)
26.06
(3.937)
26.88
(4.685)
Years since Schizophrenia Diagnosis (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
11.8
(6.81)
12.1
(9.17)
9.6
(8.12)
9.3
(7.45)
11.5
(7.98)
6.4
(5.34)
10.9
(8.09)
Time since Acute Exacerbation or relapse (weeks) (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]
0.4
(0.18)
0.3
(0.21)
0
(0)
0.4
(0.20)
0.4
(0.24)
0
(0)
0.4
(0.21)

Outcome Measures

1. Primary Outcome
Title PANSS Total Score Mean Change From Baseline to Endpoint
Description The Positive and Negative Syndrome Scale (PANSS) is a 30-item clinician-rated instrument for assessing the symptoms of schizophrenia.The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 PANSS items and ranges from 30 to 210, with 30 indicating absence of symptoms of schizophrenia and 210 indicating extreme ratings of all 30 symptoms. Negative change from baseline scores indicates improvements in symptoms whereas higher scores mean a worse outcome. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.
Time Frame Baseline and Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone ISM 75mg/Risperidone ISM 75mg De Novo/Risperidone ISM 75mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive either Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM® in the OLE study. Their previous oral risperidon was more than 4 mg/day to a maximum of 6 mg/day
Measure Participants 27 58 31 28 61 10
Mean (Standard Deviation) [units on a scale]
-22.9
(14.15)
-11.0
(14.52)
-0.8
(9.39)
-18.9
(14.61)
-8.7
(13.29)
-4.8
(4.80)
2. Other Pre-specified Outcome
Title PANSS Positive Subscale Mean Change From Baseline to Endpoint
Description The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.
Time Frame Baseline and Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone 75 mg/Risperidone 75 mg De Novo/Risperidone ISM 75 mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
Measure Participants 27 58 31 28 61 10
Mean (Standard Deviation) [units on a scale]
-6.0
(4.84)
-3.3
(5.47)
-0.6
(3.32)
-6.5
(5.32)
-2.6
(4.75)
-1.6
(2.67)
3. Other Pre-specified Outcome
Title PANSS Negative Subscale Mean Change From Baseline to Endpoint
Description The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.
Time Frame Baseline and Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Risperidone ISM 75 mg/Risperidone ISM 75 mg De Novo/Risperidone ISM 75 mg Rollover Placebo/Risperidone ISM 100 mg Risperidone ISM 100/Risperidone ISM 100 De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
Measure Participants 27 58 31 28 61 10
Mean (Standard Deviation) [units on a scale]
-4.6
(5.24)
-2.2
(3.61)
-0.3
(3.21)
-2.9
(3.75)
-2.1
(3.66)
-0.7
(4.22)
4. Other Pre-specified Outcome
Title PANSS General Psychopathology Subscale Mean Change From Baseline to Endpoint
Description The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The general psychopathology scale consists of 16 items which measure somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation and active social avoidance. PANSS General Psychopathology Subscale Score ranges from 16 (absence of symptoms) to 112 (extremely severe symptoms). Endpoint is defined as study day 356 or the last post-baseline assessment if early discontinuation.
Time Frame Baseline and Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone ISM 75mg/Risperidone ISM 75mg De Novo/Risperidone ISM 75mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
Measure Participants 27 58 31 28 61 10
Mean (Standard Deviation) [units on a scale]
-12.4
(8.33)
-5.4
(7.35)
0.2
(5.73)
-9.4
(7.43)
-3.9
(7.37)
-2.5
(2.88)
5. Other Pre-specified Outcome
Title Clinician Global Impression - Severity (CGI-S) Total Score Mean Change From Baseline to Endpoint
Description The Clinician Global Impression - Severity (CGI-S) score is a 7-point clinician-rated scale for assessing the global severity of the illness. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Negative change from baseline scores indicate improvement in the severity of illness whereas higher scores mean a worse outcome. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.
Time Frame Baseline and Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone ISM 75mg/Risperidone ISM 75mg De Novo/Risperidone ISM 75mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
Measure Participants 27 58 31 28 61 10
Mean (Standard Deviation) [units on a scale]
-1.3
(1.02)
-0.5
(0.94)
0.0
(0.53)
-1.0
(0.88)
-0.3
(0.80)
-0.1
(0.32)
6. Other Pre-specified Outcome
Title Clinician Global Impression - Improvement (CGI-I) Score
Description The Clinical Global Impression - Improvement (CGI-I) is a single 7-point rating score total improvement, regardless of whether or not the change it is due entirely to drug treatment. Raters select one response based on the following question, "Compared to your patient's condition at the beginning of treatment, how much has your patient changed?" Scores are: 1, Very much improved; 2, Much improved; 3, Minimally improved; 4, No change; 5, Minimally worse; 6, Much worse; or 7, Very much worse. Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.
Time Frame Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone ISM 75mg/Risperidone ISM 75mg De Novo/Risperidone ISM 75mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
Measure Participants 27 58 31 28 61 10
Mean (Standard Deviation) [score on a scale]
2.3
(1.18)
2.9
(1.14)
3.7
(1.09)
2.4
(0.92)
2.9
(1.24)
3.1
(1.10)
7. Other Pre-specified Outcome
Title Overall Response Rate at Endpoint
Description Overall response was defined as either PANSS total score ≥ 30% decrease from baseline, or CGI-I score of 2 (much improved) or 1 (very much improved). Endpoint is defined as study day 365 or the last post-baseline assessment if early discontinuation.
Time Frame Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone ISM 75mg/Risperidone ISM 75mg De Novo/Risperidone ISM 75mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
Measure Participants 27 58 31 28 61 10
Number (95% Confidence Interval) [percentage of participants]
74.1
274.4%
44.8
77.2%
9.7
31.3%
64.3
229.6%
45.9
75.2%
20.0
200%
8. Other Pre-specified Outcome
Title Relapse Rate
Description Relapse was defined as either increase from baseline in PANSS total score ≥30% or rehospitalization for psychotic symptoms or use of adjunctive antipsychotic medication after stabilization.
Time Frame Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study.
Arm/Group Title Rollover Placebo/Risperidone ISM 75 mg Rollover Risperidone ISM 75mg/Risperidone ISM 75mg De Novo/Risperidone ISM 75mg Rollover Placebo/Risperidone ISM 100 mg Rollover Risperidone ISM 100 mg/Risperidone ISM 100 mg De Novo/Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were those who had been receiving 75 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 75 mg during the OLE study. Patients assigned to this arm were de novo participants who received 75 mg of Risperidone ISM during the OLE study. Their previous oral risperidone dose was 4 mg/day. Patients assigned to this arm were those who had been receiving placebo in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were those who had been receiving 100 mg of Risperidone ISM in the previous double-blind study and they were randomly assigned to receive Risperidone ISM 100 mg during the OLE study. Patients assigned to this arm were de novo participants who received 100 mg of Risperidone ISM in the OLE study. Their previous oral risperidone was more than 4 mg/day to a maximum of 6 mg/day.
Measure Participants 27 58 31 28 61 10
Number (95% Confidence Interval) [percentage of participants]
11.1
41.1%
10.3
17.8%
12.9
41.6%
0
0%
13.1
21.5%
20.0
200%
9. Other Pre-specified Outcome
Title Patients With Treatment Emergent Adverse Events (TEAEs)
Description An Adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study (from the informed consent form signature) or, if present at screening, worsens during the study, regardless of the suspected cause of the event. The treatment-emergent AEs (TEAEs) are defined as events that are newly occurring or worsening from the time of the first dose of the intramuscular study drug.
Time Frame Up to Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates.
Arm/Group Title Risperidone ISM 75 mg Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm received 75 mg of Risperidone ISM during the open label extension. Risperidone ISM 75 mg: Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle. Patients assigned to this arm received 100 mg of Risperidone ISM during the open label extension. Risperidone ISM 100 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Measure Participants 116 99
Patients with at least one TEAE
81
300%
59
101.7%
Patients with at least one treatment-related TEAE
43
159.3%
41
70.7%
Patients with at least one serious TEAE
6
22.2%
5
8.6%
Patients with at least one TEAE leading to treatment discontinuation
7
25.9%
8
13.8%
Patients with at least one TEAE leading to death
1
3.7%
0
0%
10. Other Pre-specified Outcome
Title TEAEs Leading to Study Drug Discontinuation
Description TEAEs which resulted in permanent study drug discontinuation
Time Frame Up to Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates.
Arm/Group Title Risperidone ISM 75 mg Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm received 75 mg of Risperidone ISM during the open label extension. Risperidone ISM 75 mg: Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle. Patients assigned to this arm received 100 mg of Risperidone ISM during the open label extension. Risperidone ISM 100 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Measure Participants 116 99
Akathisia
0
0%
1
1.7%
Diabetes mellitus
1
3.7%
0
0%
Extrapyramidal disorder
1
3.7%
0
0%
Gynaecomastia
0
0%
1
1.7%
Hepatic Steatosis
0
0%
1
1.7%
Hepatocellular injury
0
0%
1
1.7%
Libido decreased
1
3.7%
0
0%
Schizophrenia
2
7.4%
5
8.6%
Suicidal ideation
1
3.7%
0
0%
Weight increased
1
3.7%
0
0%
11. Other Pre-specified Outcome
Title Patients With Treatment-related TEAEs
Description An Adverse event (AE) is any symptom, physical sign, syndrome, or disease that either emerges during the study (from the informed consent form signature) or, if present at screening, worsens during the study, regardless of the suspected cause of the event. The treatment-emergent AEs (TEAEs) are defined as events that are newly occurring or worsening from the time of the first dose of the intramuscular study drug. The temporal relationship of the AE with the investigational medicinal product makes causality possible, and the AE cannot be due to another cause such as other drugs, a surgical intervention, or an underlying disease
Time Frame Up to Day 365 (or the last post-baseline assessment)

Outcome Measure Data

Analysis Population Description
The analysis was undertaken on the population of patients who received at least one dose of study drug during the OLE study. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates.
Arm/Group Title Risperidone ISM 75 mg Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm received 75 mg of Risperidone ISM during the open label extension. Risperidone ISM 75 mg: Monthly (once every 4 weeks) intramuscular (IM) injection in the gluteal or deltoid muscle. Patients assigned to this arm received 100 mg of Risperidone ISM during the open label extension. Risperidone ISM 100 mg: Monthly (once every 4 weeks) IM injection in the gluteal or deltoid muscle.
Measure Participants 116 99
Akathisia
4
14.8%
4
6.9%
Asthenia
7
25.9%
4
6.9%
Dizziness
3
11.1%
3
5.2%
Headache
16
59.3%
10
17.2%
Hyperprolactinemia
11
40.7%
10
17.2%
Insomnia
6
22.2%
3
5.2%
Weight increased
6
22.2%
3
5.2%

Adverse Events

Time Frame Day 1 to week 52
Adverse Event Reporting Description
Arm/Group Title Risperidone ISM 75 mg Risperidone ISM 100 mg
Arm/Group Description Patients assigned to this arm will received 75 mg of Risperidone ISM during the open label extension. Risperidone ISM 75 mg: Monthly intramuscular (IM) injection in the gluteal or deltoid muscle. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates. Patients assigned to this arm will received 100 mg of Risperidone ISM during the open label extension. Risperidone ISM 100 mg: Monthly IM injection in the gluteal or deltoid muscle. Safety data were pooled in two comparison groups (Risperidone ISM 75 mg and Risperidone ISM 100 mg) because the sample size increased and therefore the precision around the estimates.
All Cause Mortality
Risperidone ISM 75 mg Risperidone ISM 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/116 (0.9%) 0/99 (0%)
Serious Adverse Events
Risperidone ISM 75 mg Risperidone ISM 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 6/116 (5.2%) 5/99 (5.1%)
Injury, poisoning and procedural complications
Intentional overdose 1/116 (0.9%) 1 0/99 (0%) 0
Psychiatric disorders
Completed suicide 1/116 (0.9%) 1 0/99 (0%) 0
Insomnia 1/116 (0.9%) 1 0/99 (0%) 0
Schizophrenia 3/116 (2.6%) 4 4/99 (4%) 4
Suicidal ideation 1/116 (0.9%) 1 0/99 (0%) 0
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease 0/116 (0%) 0 1/99 (1%) 1
Other (Not Including Serious) Adverse Events
Risperidone ISM 75 mg Risperidone ISM 100 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 81/116 (69.8%) 59/99 (59.6%)
Endocrine disorders
Hyperprolactinaemia 11/116 (9.5%) 13 10/99 (10.1%) 10
Gastrointestinal disorders
Diarrhoea 5/116 (4.3%) 5 1/99 (1%) 2
Toothache 4/116 (3.4%) 8 3/99 (3%) 3
General disorders
Asthenia 7/116 (6%) 8 4/99 (4%) 5
Infections and infestations
Nasopharyngitis 13/116 (11.2%) 15 9/99 (9.1%) 9
Investigations
Alanine aminotransferase increased 2/116 (1.7%) 2 3/99 (3%) 4
Weight increased 8/116 (6.9%) 9 4/99 (4%) 4
Nervous system disorders
Akathisia 4/116 (3.4%) 4 4/99 (4%) 5
Dizziness 4/116 (3.4%) 4 3/99 (3%) 3
Headache 24/116 (20.7%) 46 18/99 (18.2%) 29
Psychiatric disorders
Anxiety 3/116 (2.6%) 3 4/99 (4%) 4
Insomnia 13/116 (11.2%) 16 3/99 (3%) 6
Schizophrenia 5/116 (4.3%) 9 5/99 (5.1%) 7

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The sponsor does not object to publication by the Institution of the results of the Trial based on information collected/generated by the Institution. The Institution will provide Sponsor an opportunity to review any proposed publication before it is submitted. If the Trial is part of a multi-center trial, the Institution agress that the first publication is to be a joint publication involving all Trials sites.

Results Point of Contact

Name/Title Director of Medical Department
Organization Laboratorios Farmacéuticos Rovi, S.A.
Phone 91 375 62 30
Email departamento.medico@rovi.es
Responsible Party:
Rovi Pharmaceuticals Laboratories
ClinicalTrials.gov Identifier:
NCT03870880
Other Study ID Numbers:
  • ROV-RISP-2016-01_OLE
First Posted:
Mar 12, 2019
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2019