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

Sponsor

Sunovion (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04072354

Collaborator

(none)

525

Enrollment

Locations

Arms

39.9

Anticipated Duration (Months)

9.4

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 13 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 50 locations worldwide. The study will last up to 9 weeks total time.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: SEP-363856 50mg Drug: SEP-363856 75mg 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 (50 and 75 mg/day) versus placebo over a 6-week Treatment Period in acutely psychotic subjects with schizophrenia. This study is projected to randomize approximately 435 subjects (18-65 years) to 3 treatment groups (SEP-363856 50 mg/day, SEP-363856 75 mg/day, or placebo) in a 1:1:1 ratio. In addition, the study will randomize approximately 90 adolescent subjects (13-17 years) in a 1:1:1 ratio to the 3 treatment groups (with approximately 30 subjects per group) in a separate cohort. 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 hypothesis 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 :

525 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized, double-blind, parallel-group, placebo controlled, fixed-dose multicenter studyrandomized, 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 11, 2019

Anticipated Primary Completion Date :

Jan 6, 2023

Anticipated Study Completion Date :

Jan 6, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SEP-363856 50mg SEP-363856 50mg dosed once daily	Drug: SEP-363856 50mg SEP-363856 50mg tablet dosed once daily
Experimental: SEP-363856 75mg SEP-363856 75mg dosed once daily	Drug: SEP-363856 75mg SEP-363856 75mg tablet dosed once daily
Placebo Comparator: Placebo Placebo dosed once daily	Drug: Placebo Placebo tablet dosed once daily

Arm

Intervention/Treatment

Experimental: SEP-363856 50mg

SEP-363856 50mg dosed once daily

Drug: SEP-363856 50mg

SEP-363856 50mg tablet dosed once daily

Experimental: SEP-363856 75mg

SEP-363856 75mg dosed once daily

Drug: SEP-363856 75mg

SEP-363856 75mg 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:

13 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.
Subject or subjects parent/legal guardian [adolescents] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent..
Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening
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 of 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 the investigator.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Woodland International Research Group, LLC	Little Rock	Arkansas	United States	72211
2	Advanced Research Center, Inc.	Anaheim	California	United States	92805
3	CITrials	Bellflower	California	United States	90706
4	Synergy San Diego	Lemon Grove	California	United States	91945
5	Alliance for Research	Long Beach	California	United States	90807
6	Catalina Research Institute	Montclair	California	United States	91763
7	Catalina Research Institute	Montclair	California	United States	91763
8	NRC Research Institute	Orange	California	United States	92868
9	California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)	Pico Rivera	California	United States	90660
10	UCSD Medical Center,UCSD Department of Psychiatry	San Diego	California	United States	92103-8229
11	Larkin Behavioral Health Services	Hollywood	Florida	United States	33021
12	Research Centers of America	Hollywood	Florida	United States	33024
13	Advanced Discovery Research LLC	Atlanta	Georgia	United States	30318
14	Atlantic Center for Medical Research	Atlanta	Georgia	United States	30331
15	CBH Health, LLC	Gaithersburg	Maryland	United States	20877
16	Precise Research Centers	Flowood	Mississippi	United States	39232
17	Arch Clinical Trials, LLC	Saint Louis	Missouri	United States	63125
18	Clinical Research of Southern Nevada, LLC	Las Vegas	Nevada	United States	89128
19	Midwest Clinical Research Center	Dayton	Ohio	United States	45417
20	Community Clinical Research	Austin	Texas	United States	78754
21	State Psychiatric Hospital - Pazardzhik AD-Department of Active Treatment of Men Department for Active Treatment of Woman Department of Active Treatment of Mean and Woman	Pazardzhik		Bulgaria	4400
22	UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic	Pleven		Bulgaria	5800
23	Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders	Sofia		Bulgaria	1202
24	UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry	Sofia		Bulgaria	1431
25	UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry	Sofia		Bulgaria	1431
26	First Department for Active Treatment - Men Second Department for Active Treatment - Men Women Department - Rehabilitation Sector Women Department - Acute Sector	Tsarev		Bulgaria	9747
27	Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders	Veliko Tarnovo		Bulgaria	5000
28	Mental Health Center - Vratsa EOOD-Department of General Psychiatry	Vratsa		Bulgaria	3000
29	State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1	Chelyabinsk		Russian Federation	454087
30	State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"	Karelia		Russian Federation	186131
31	SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"	Moscow		Russian Federation	107076
32	State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod	Nizniy Novgorod		Russian Federation	603155
33	FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12	Saint Petersburg		Russian Federation	192019
34	State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"	Samara		Russian Federation	443016
35	State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents	Saratov		Russian Federation	410028
36	FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12	St. petersburg		Russian Federation	092019
37	Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry	Belgrade		Serbia	11000
38	Clinical Center Nis, Center of Mental Health Protection	Belgrade		Serbia	11000
39	Institute of Mental Health	Belgrade		Serbia	11000
40	Institute of Mental Health	Belgrade		Serbia	11000
41	Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39	Gornja Toponica		Serbia	18202
42	Special Neuropsychiatric Hospital Kovin	Kovin		Serbia	26220
43	Clinical Center Kragujevac, Clinic of Psychiatry	Kragujevac		Serbia	34000
44	University Clinical Center Nis, Clinic of Psychiatry	Nis		Serbia	18000
45	Clinical Center of Vojvodina, Clinic of Psychiatry	Novi Sad		Serbia	21000
46	Special Hospital for Psychiatric Diseases	Vrsac		Serbia	26300
47	15, Medychna St	Ivano-Frankivsk		Ukraine	76011
48	2-A Metalurgiv st	Kropyvnytskyi		Ukraine	25491
49	Dr. Vladyslav Demchenko	Kyiv		Ukraine	02192
50	103 Kyrylivska St	Kyiv		Ukraine	04080
51	Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25	Lviv		Ukraine	79021
52	9 Academician Vorobiov St	Odesa		Ukraine	65006
53	1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region	Odesa		Ukraine	67513
54	1 Medychna St	Poltava		Ukraine	36013
55	Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12	Smila		Ukraine	20708
56	Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital	Vinnytsia		Ukraine	21005

Sponsors and Collaborators

Sunovion

Investigators

Study Chair: CNS Medical Director, Sunovion Pharmaceuticals In.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sunovion

ClinicalTrials.gov Identifier:

NCT04072354

Other Study ID Numbers:

SEP361-301
2019-000470-36

First Posted:

Aug 28, 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