A Clinical Trial That Will 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: NCT04092686
• Other study ID #: 361-302
• Secondary ID: 2019-000697-37
• Status: Completed
• Phase: Phase 3
• Start date: September 30, 2019
• Est. completion date: June 14, 2023

Study information

• Verified date: November 2023
• 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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 464
• Est. completion date: June 14, 2023
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.

2. Subject must give written informed consent and privacy authorization prior to participation in the study; adolescents must also provide informed assent.

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

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 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.

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 investigator.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SEP-363856 75mg
SEP-363856 75mg tablet dosed once daily
• SEP-363856 100mg
SEP-363856 100mg tablet dosed once daily
• Placebo
Placebo tablet dosed once daily

Locations

Country	Name	City	State
Bulgaria	Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions	Burgas
Bulgaria	State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment	Kardzhali
Bulgaria	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	UMHAT Sveti Georgi EAD	Plovdiv
Bulgaria	Mental Health Center - Sofia EOOD Unit for Active Treatment of Persons with Serious Mental Disorders	Sofia
Bulgaria	UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry	Sofia
Croatia	Psychiatric Hospital "Sveti Ivan"	Zagreb
Latvia	LTD Psychoeurological Hospital of Daugavpils	Daugavpils
Latvia	SLLC Riga Centre of Psychiatry and Narcology	Riga
Latvia	SLLC Psychoneurological Hospital of Strenci	Strenci
Russian Federation	State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"	Arkhangelsk
Russian Federation	State Healthcare Institution "Psychiatric Hospital of Engels" of MoH of Saratov Region, departments ? 1 and 3, 166	Engels
Russian Federation	State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary	Leningrad
Russian Federation	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	State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5"	Moscow
Russian Federation	FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3	Saint Petersburg
Russian Federation	Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add	Saint Petersburg
Russian Federation	Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov"	Saint Petersburg
Russian Federation	State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments	Saratov
Russian Federation	State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia	Saratov
Russian Federation	FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF	St. Petersburg
Russian Federation	State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2"	Stavropol
Russian Federation	Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of Russian Academy of Sciences",	Tomsk
Serbia	Clinic of Psychiatry, Clinical Center of Serbia	Belgrade
Serbia	Clinic of Psychiatry, Clinical Center of Serbia,	Belgrade
Serbia	Clinical Center "Dr Dragisa Misovic- Dedinje"	Belgrade
Serbia	Special Hospital for Psychiatric Diseases "Kovin"	Kovin
Serbia	Special Neuropsychiatric Hospital Kovin	Kovin
Serbia	Clinic of Psychiatry, clinical Center Kragujevac	Kragujevac
Serbia	University Clinical Center Kragujevac, Clinic of Psychiatry	Kragujevac
Serbia	University Clinical Center Nis, Clinic of Psychiatry	Nis
Serbia	Special Hospital for Psychiatric Disease Sveti Vracevi	Novi Knezevac
Serbia	Special Hospital for Psychiatric Diseases "SVeti Vracevi"	Novi Knezevac
Serbia	Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"	Vrsac
Ukraine	46 Academician Pavlov St	Kharkiv
Ukraine	State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry	Kharkiv
Ukraine	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	Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2	Kyiv
Ukraine	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	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	Kyev Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian railway" Department of Psychoneurology	Kyiv
Ukraine	National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients	Kyiv
Ukraine	Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20	Lviv
Ukraine	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
United States	Advanced Research Center, Inc.	Anaheim	California
United States	Atlanta Center for Medical Research	Atlanta	Georgia
United States	Clinical Innovations, Inc.	Bellflower	California
United States	Pillar Clinical Research	Chicago	Illinois
United States	ProScience Research Group	Culver City	California
United States	iResearch Atlanta, LLC	Decatur	Georgia
United States	CBH Health, LLC	Gaithersburg	Maryland
United States	Larkin Behavioral Health Services	Hollywood	Florida
United States	Lake Charles Clinical Trials	Lake Charles	Louisiana
United States	Collaborative Neuroscience Network	Long Beach	California
United States	Hassman Research Institute	Marlton	New Jersey
United States	South Florida Research Phase I-IV, INC.	Miami Springs	Florida
United States	New York State Psychiatric Institute	New York	New York
United States	Pillar Clinical Research	Richardson	Texas
United States	Woodland Research Northwest	Rogers	Arkansas
United States	Arch Clinical Trials, LLC	Saint Louis	Missouri
United States	California Neuropsychopharmacology Clinical Research Institute	San Diego	California
United States	Schuster Medical Research Institute	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Sumitomo Pharma America, Inc.

Countries where clinical trial is conducted

United States,  Bulgaria,  Croatia,  Latvia,  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