A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

Sponsor

Sunovion (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04092686

Collaborator

(none)

462

Enrollment

Locations

Arms

40.4

Anticipated Duration (Months)

8.3

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 40 locations world wide. The study will last up to nine (9) weeks.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: SEP-363856 75mg Drug: SEP-363856 100mg Drug: Placebo	Phase 3

Detailed Description

This is a multicenter, randomized, double-blind, parallel-group, fixed-dosed study evaluating the efficacy and safety of two doses of SEP-363856 (75 and 100 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 462 subjects to 3 treatment groups (SEP-363856 75 mg/day, SEP-363856 100 mg/day, or placebo) in a 1:1:1 ratio. Treatment assignment will be stratified by country. Study drug will be taken once a day and may be taken with or without food.

This study is designed to test the hypotheses that treatment with SEP-363856 in adult subjects with schizophrenia will result in significantly greater reduction (i.e. improvement) in PANSS total score and CGI-S score at Week 6 from Baseline when compared to placebo. The overall Type I error is controlled for two hierarchical families of hypotheses. The first family includes hypotheses about the testing of change from Baseline in PANSS total score at Week 6 between each of the SEP-363856 dose levels vs. placebo. The second family of hypotheses are about the testing of change from Baseline in CGI-S score at Week 6 between each of the SEP-363856 dose levels vs. placebo.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

462 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter studyA randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

double-blind

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia

Actual Study Start Date :

Sep 30, 2019

Anticipated Primary Completion Date :

Feb 10, 2023

Anticipated Study Completion Date :

Feb 10, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SEP-363856 75mg SEP-363856 75mg dosed once daily	Drug: SEP-363856 75mg SEP-363856 75mg tablet dosed once daily
Experimental: SEP-363856 100mg SEP-363856 100mg dosed once daily	Drug: SEP-363856 100mg SEP-363856 100mg tablet dosed once daily
Placebo Comparator: Placebo Placebo dosed once daily	Drug: Placebo Placebo tablet dosed once daily

Arm

Intervention/Treatment

Experimental: SEP-363856 75mg

SEP-363856 75mg dosed once daily

Drug: SEP-363856 75mg

SEP-363856 75mg tablet dosed once daily

Experimental: SEP-363856 100mg

SEP-363856 100mg dosed once daily

Drug: SEP-363856 100mg

SEP-363856 100mg tablet dosed once daily

Placebo Comparator: Placebo

Placebo dosed once daily

Drug: Placebo

Placebo tablet dosed once daily

Outcome Measures

Primary Outcome Measures

Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6) [Baseline and Week 6]
PANSS is comprised of 30 items and 3 subscales (Positive, Negative, General Psychopathology). An anchored Likert scale from 1 - 7, where values of 2 and above indicate the presence of progressively more severe symptoms, is used to score each item. Individual items are then summed to determine scores for the 3 subscales, as well as a total score. PANSS Positive subscale score range: 7-49. PANSS Negative subscale score range: 7-49. PANSS General Psychopathology subscale score range: 16-112. PANSS total score range: 30-210.

Secondary Outcome Measures

Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6) [Baseline and Week 6]
The CGI-S is a single-item clinician-rated assessment of the subject's current illness state on a 7-point scale (score range: 1-7), where a higher score is associated with greater illness severity.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.
Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screeing.
Subject must have a CGI-S score ≥ 4
Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content
Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).
Subject has marked deterioration of functioning in one or more areas.
Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG and clinical laboratory values.

Exclusion Criteria:

Subject has a DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment.
Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.
Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study
Female subject who is pregnant or lactating
Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woodland International Research Group	Little Rock	Arkansas	United States	72211
2	Woodland Research Northwest	Rogers	Arkansas	United States	72758
3	Advanced Research Center, Inc.	Anaheim	California	United States	92805
4	Collaborative Neuroscience Network	Long Beach	California	United States	90806
5	California Neuropsychopharmacology Clinical Research Institute	San Diego	California	United States	92102
6	UCSD Medical Center UCSD Department of Psychiatry	San Diego	California	United States	92103-8229
7	Schuster Medical Research Institute	Sherman Oaks	California	United States	91403
8	Larkin Behavioral Health Services	Hollywood	Florida	United States	33021
9	Atlanta Center for Medical Research	Atlanta	Georgia	United States	30331
10	iResearch Atlanta, LLC	Decatur	Georgia	United States	30030
11	Lake Charles Clinical Trials	Lake Charles	Louisiana	United States	70629
12	CBH Health, LLC	Gaithersburg	Maryland	United States	20877
13	Precise Research Centers	Flowood	Mississippi	United States	39232
14	Arch Clinical Trials, LLC	Saint Louis	Missouri	United States	63125
15	Hassman Research Institute	Marlton	New Jersey	United States	08053
16	New York State Psychiatric Institute	New York	New York	United States	10032
17	Pillar Clinical Research	Richardson	Texas	United States	75080
18	Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions	Burgas		Bulgaria	8000
19	State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment	Kardzhali		Bulgaria	6600
20	State Psychiatric Hospital Sv. Ivan rilski-Department General Psychiatry for Adults "closed" Type -Men, Department General Psychiatry for Adults, "Closed" Type - Women	Novi Iskar		Bulgaria	1282
21	UMHAT Sveti Georgi EAD	Plovdiv		Bulgaria	4000
22	UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry	Sofia		Bulgaria	1431
23	State Psychiatric Hospital - s. Tsarev brod First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector	Tsarev		Bulgaria	9747
24	LTD Psychoeurological Hospital of Daugavpils	Daugavpils		Latvia	LV-5417
25	SLLC Riga Centre of Psychiatry and Narcology	Riga		Latvia	LV-1005
26	SLLC Psychoneurological Hospital of Strenci	Strenci		Latvia	LV-4730
27	State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"	Arkhangelsk		Russian Federation	163530
28	State Healthcare Institution "Psychiatric Hospital of Engels" of MoH of Saratov Region, departments № 1 and 3, 166	Engels		Russian Federation	413124
29	State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary	Leningrad		Russian Federation	188820
30	State Budgetary Institution of Healthcare of Moscow "Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow	Moscow		Russian Federation	117152
31	State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5"	Moscow		Russian Federation	141371
32	Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add	Saint Petersburg		Russian Federation	190005
33	FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3	Saint Petersburg		Russian Federation	192019
34	Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov"	Saint Petersburg		Russian Federation	197341
35	Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov"	Saint Petersburg		Russian Federation	197341
36	State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments	Saratov		Russian Federation	410028
37	State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia	Saratov		Russian Federation	410060
38	FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF	St. Petersburg		Russian Federation	192019
39	State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2"	Stavropol		Russian Federation	357034
40	Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of Russian Academy of Sciences",	Tomsk		Russian Federation	634014
41	Clinic of Psychiatry, Clinical Center of Serbia,	Belgrade		Serbia	11000
42	Clinic of Psychiatry, Clinical Center of Serbia	Belgrade		Serbia	11000
43	Special Neuropsychiatric Hospital Kovin	Kovin		Serbia	26220
44	Clinic of Psychiatry, clinical Center Kragujevac	Kragujevac		Serbia	34000
45	Clinic of Psychiatry, Clinical Center Kragujevac	Kragujevac		Serbia	34000
46	Special Hospital for Psychiatric Disease Sveti Vracevi	Novi Knezevac		Serbia	23330
47	46 Academician Pavlov St	Kharkiv		Ukraine	61068
48	State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry	Kharkiv		Ukraine	61068
49	Communica Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10	Kherson		Ukraine	73488
50	Kyev Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian railway" Department of Psychoneurology	Kyiv		Ukraine	01030
51	National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients	Kyiv		Ukraine	01133
52	Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2	Kyiv		Ukraine	08631
53	Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4 ,	Kyiv		Ukraine	08631
54	Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4	Kyiv		Ukraine	08631
55	Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20	Lviv		Ukraine	79021
56	Communal Institution O.I. Yuschenko Vinnytsia Regional Psychoneurological Hospital, Male Department #21, Female Department #15, M.I. Pyrogov Vinnytsia National Medical University, Chair of Psychiatry, Narcology and Psychotherapy with Postgraduate Educatio	Vinnytsia		Ukraine	21005

Sponsors and Collaborators

Sunovion

Investigators

Study Chair: CNS Medical Director, Sunovion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunovion

ClinicalTrials.gov Identifier:

NCT04092686

Other Study ID Numbers:

361-302
2019-000697-37

First Posted:

Sep 17, 2019

Last Update Posted:

Aug 2, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sunovion

acute psychosis

Schizophrenia

Additional relevant MeSH terms:

Schizophrenia

Study Results

No Results Posted as of Aug 2, 2022