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

NCT ID: NCT04092686

Last Updated: 2024-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 464 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-30
• Study Completion Date: 2023-06-14

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 60 locations world wide. The study will last up to nine (9) weeks.

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SEP-363856 75mg

SEP-363856 75mg dosed once daily

Group Type: EXPERIMENTAL

SEP-363856 75mg

Intervention Type: DRUG

SEP-363856 75mg tablet dosed once daily

SEP-363856 100mg

SEP-363856 100mg dosed once daily

Group Type: EXPERIMENTAL

SEP-363856 100mg

Intervention Type: DRUG

SEP-363856 100mg tablet dosed once daily

Placebo

Placebo dosed once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo tablet dosed once daily

Interventions

SEP-363856 75mg

SEP-363856 75mg tablet dosed once daily

Intervention Type: DRUG

SEP-363856 100mg

SEP-363856 100mg tablet dosed once daily

Intervention Type: DRUG

Placebo

Placebo tablet dosed once daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Woodland Research Northwest

Rogers, Arkansas, United States

Advanced Research Center, Inc.

Anaheim, California, United States

Clinical Innovations, Inc.

Bellflower, California, United States

ProScience Research Group

Culver City, California, United States

Collaborative Neuroscience Network

Long Beach, California, United States

California Neuropsychopharmacology Clinical Research Institute

San Diego, California, United States

Schuster Medical Research Institute

Sherman Oaks, California, United States

Larkin Behavioral Health Services

Hollywood, Florida, United States

South Florida Research Phase I-IV, INC.

Miami Springs, Florida, United States

Atlanta Center for Medical Research

Atlanta, Georgia, United States

iResearch Atlanta, LLC

Decatur, Georgia, United States

Pillar Clinical Research

Chicago, Illinois, United States

Lake Charles Clinical Trials

Lake Charles, Louisiana, United States

CBH Health, LLC

Gaithersburg, Maryland, United States

Arch Clinical Trials, LLC

St Louis, Missouri, United States

Hassman Research Institute

Marlton, New Jersey, United States

New York State Psychiatric Institute

New York, New York, United States

Pillar Clinical Research

Richardson, Texas, United States

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, , Bulgaria

Psychiatric Hospital "Sveti Ivan"

Zagreb, , Croatia

LTD Psychoeurological Hospital of Daugavpils

Daugavpils, , Latvia

SLLC Riga Centre of Psychiatry and Narcology

Riga, , Latvia

SLLC Psychoneurological Hospital of Strenci

Strenči, , Latvia

State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"

Arkhangelsk, , Russia

State Healthcare Institution "Psychiatric Hospital of Engels" of MoH of Saratov Region, departments № 1 and 3, 166

Engel's, , Russia

State Budgetary Institution of Healthcare of Moscow "Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow

Moscow, , Russia

State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5"

Moscow, , Russia

State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary

Saint Petersburg, , Russia

Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add

Saint Petersburg, , Russia

FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF

Saint Petersburg, , Russia

FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3

Saint Petersburg, , Russia

Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov"

Saint Petersburg, , Russia

State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments

Saratov, , Russia

State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia

Saratov, , Russia

State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2"

Stavropol, , Russia

Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of Russian Academy of Sciences",

Tomsk, , Russia

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

Niš, , Serbia

Special Hospital for Psychiatric Disease Sveti Vracevi

Novi Kneževac, , Serbia

Special Hospital for Psychiatric Diseases "SVeti Vracevi"

Novi Kneževac, , Serbia

Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"

Vršac, , Serbia

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

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 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

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, , Ukraine

Countries

United States; Bulgaria; Croatia; Latvia; Russia; Serbia; Ukraine

Other Identifiers

2019-000697-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

361-302

Identifier Type: -

Identifier Source: org_study_id