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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04072354
• Other study ID #: SEP361-301
• Secondary ID: 2019-000470-36
• Status: Completed
• Phase: Phase 3
• Start date: September 11, 2019
• Est. completion date: September 12, 2023

Study information

• Verified date: May 2024
• Source: Sumitomo Pharma America, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 70 locations worldwide. The study will last up to 9 weeks total time.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 463
• Est. completion date: September 12, 2023
• Est. primary completion date: May 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent.

2. 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..

3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening

4. Subject must have a CGI-S score = 4

5. 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

6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent).

7. Subject has marked deterioration of functioning in one or more areas.

8. 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:

1. 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.

2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment.

3. 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:

4. Female subject who is pregnant or lactating

5. Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the investigator.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SEP-363856 50mg
SEP-363856 50mg tablet dosed once daily
• SEP-363856 75mg
SEP-363856 75mg tablet dosed once daily
• Placebo
Placebo tablet dosed once daily

Locations

Country	Name	City	State
Bulgaria	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	UMHAT-Dr. Georgi Stranski EAD-First Psychiatric clinic	Pleven
Bulgaria	Mental Health Center-Sofia EOOD - Unit for Active Treatment of Persons with serious Mental Disorders	Sofia
Bulgaria	UMHAT Alexandrovska EAD, First Department of Psychiatry at Clinic of Psychiatry	Sofia
Bulgaria	UMHAT Alexandrovska EAD, Second Department of Pshychiatry at Clinic of Psychiatry	Sofia
Bulgaria	Mental Health Center-Veliko Tarnovo EOOD-Deparmtentsof psychiatry for active treatment of persons with acute psychotic disorders	Veliko Tarnovo
Bulgaria	Mental Health Center - Vratsa EOOD-Department of General Psychiatry	Vratsa
Colombia	E.S.E Hospital Mental de Antioquia - Unidad de Investigación	Bello	Antioquia
Colombia	Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda	Bogota
Colombia	Centro de Investigaciones y Proyectos en Neurociencias CIPNA	Bogota
Colombia	Centro de Investigaciones del Sistema Nervioso Limitada - Grupo CISNE Ltda	Bogotá
Russian Federation	State Budgetrary Institution of Healthcare Regional Clinical Specialized Psychiatric Hospital #1	Chelyabinsk
Russian Federation	SBIH of Moscow "Psychiatric Clinical Hospital #4 n.a. P.B. Gannushkin"	Moscow
Russian Federation	State Budgetary Institution of Healthcare of nizhniy Novgorod region "Clinical Psychiatric Hosptial #1 of Nizhniy Novgorod	Nizniy Novgorod
Russian Federation	State Budgetary Healthcare Institution of Republic Karelia "Republican Psyhiatric Hospital"	Petrozavodsk
Russian Federation	FSBI 'NMRC of Psychiatry and Neurology named after V.M. Bekhterev MoH RF, department 12	Saint Petersburg
Russian Federation	State Budgetary Institution of Healthcare "Samara Regional Clinical Psychiatric Hospital"	Samara
Russian Federation	State Institution of Healthcare Saratov City Clninical Hospital #2, named after V.I. Razumovskiy psychiatric deparmtents	Saratov
Russian Federation	FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF, department 12	St. petersburg
Serbia	Clinical Center "Dr. Dragisa Misovic-Dedinje" Clinic of Psychiatry	Belgrade
Serbia	Clinical Center Nis, Center of Mental Health Protection	Belgrade
Serbia	Institute of Mental Health	Belgrade
Serbia	Special Hospital for Psychiartric Diseases Gornja Toponica, Stevana, Sindjelica 39	Gornja Toponica
Serbia	Special Hospital for Psychiatric Diseases "Kovin",	Kovin
Serbia	Special Neuropsychiatric Hospital Kovin	Kovin
Serbia	Clinical Center Kragujevac, Clinic of Psychiatry	Kragujevac
Serbia	University Clinical Center Nis, Clinic of Psychiatry	Nis
Serbia	Special Hospital for Psychiatric Diseases "SVeti Vracevi",	Novi Knezevac
Serbia	Clinical Center of Vojvodina, Clinic of Psychiatry	Novi Sad
Serbia	Special Hospital for Psychiatric Diseases	Vrsac
Ukraine	15, Medychna St	Ivano-Frankivsk
Ukraine	2-A Metalurgiv st	Kropyvnytskyi
Ukraine	103 Kyrylivska St	Kyiv
Ukraine	Dr. Vladyslav Demchenko	Kyiv
Ukraine	Communal Noncommercial Enterprise of Lviv Regional Council Lviv Regional Clinical Psychiatric Hospital, Department #25	Lviv
Ukraine	1, Tsentraina Square, Oleksandrivka village, Lyman Region, Odesa Region	Odesa
Ukraine	9 Academician Vorobiov St	Odesa
Ukraine	1 Medychna St	Poltava
Ukraine	Communal Non-commercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12	Smila
Ukraine	Comm. Institution O.I. Yushchenko Vinnytsia Reg. Psychoneurologoical Hospital	Vinnytsia
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Advanced Discovery Research LLC	Atlanta	Georgia
United States	Atlantic Center for Medical Research	Atlanta	Georgia
United States	Community Clinical Research	Austin	Texas
United States	CITrials	Bellflower	California
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	Precise Research Centers	Flowood	Mississippi
United States	CBH Health, LLC	Gaithersburg	Maryland
United States	Larkin Behavioral Health Services	Hollywood	Florida
United States	Research Centers of America	Hollywood	Florida
United States	Synergy San Diego	Lemon Grove	California
United States	Woodland International Research Group, LLC	Little Rock	Arkansas
United States	Alliance for Research	Long Beach	California
United States	South Florida Research Phase I-IV, Inc.	Miami Springs	Florida
United States	Catalina Research Institute	Montclair	California
United States	California Neuropsychopharmacology Clinical Research Institute (CNRI-LA, LLC)	Pico Rivera	California
United States	UCSD Medical Center,UCSD Department of Psychiatry	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma America, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Colombia,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (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.	Baseline and Week 6
Secondary	Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (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.	Baseline and Week 6