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

NCT04092686 | Completed Phase 3 DMC FDA Drug

• 2 other identifiers: 361-3022019-000697-37
• Study Type: interventional
• Target: 464
• Locations: 7 countries
• Sites: 62

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.

Conditions

Schizophrenia

Keywords

acute psychosis; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6)

  Baseline and Week 6

Study Arms (3)

SEP-363856 75mg

EXPERIMENTAL

SEP-363856 75mg dosed once daily

Drug: SEP-363856 75mg

SEP-363856 100mg

EXPERIMENTAL

SEP-363856 100mg dosed once daily

Drug: SEP-363856 100mg

Placebo

PLACEBO COMPARATOR

Placebo dosed once daily

Drug: Placebo

Interventions

SEP-363856 75mg DRUG

SEP-363856 75mg tablet dosed once daily

SEP-363856 75mg

SEP-363856 100mg DRUG

SEP-363856 100mg tablet dosed once daily

SEP-363856 100mg

Placebo DRUG

Placebo tablet dosed once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (62)

Woodland Research Northwest

Rogers, Arkansas, 72758, United States

Location

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

Clinical Innovations, Inc.

Bellflower, California, 90706, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Collaborative Neuroscience Network

Long Beach, California, 90806, United States

Location

California Neuropsychopharmacology Clinical Research Institute

San Diego, California, 92102, United States

Location

Schuster Medical Research Institute

Sherman Oaks, California, 91403, United States

Location

Larkin Behavioral Health Services

Hollywood, Florida, 33021, United States

Location

South Florida Research Phase I-IV, INC.

Miami Springs, Florida, 33166, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

iResearch Atlanta, LLC

Decatur, Georgia, 30030, United States

Location

Pillar Clinical Research

Chicago, Illinois, 60641, United States

Location

Lake Charles Clinical Trials

Lake Charles, Louisiana, 70629, United States

Location

CBH Health, LLC

Gaithersburg, Maryland, 20877, United States

Location

Arch Clinical Trials, LLC

St Louis, Missouri, 63125, United States

Location

Hassman Research Institute

Marlton, New Jersey, 08053, United States

Location

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Pillar Clinical Research

Richardson, Texas, 75080, United States

Location

Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions

Burgas, 8000, Bulgaria

Location

State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment

Kardzhali, 6600, Bulgaria

Location

State Psychiatric Hospital Sv. Ivan rilski-Department General Psychiatry for Adults "closed" Type -Men, Department General Psychiatry for Adults, "Closed" Type - Women

Novi Iskar, 1282, Bulgaria

Location

UMHAT Sveti Georgi EAD

Plovdiv, 4000, Bulgaria

Location

Mental Health Center - Sofia EOOD Unit for Active Treatment of Persons with Serious Mental Disorders

Sofia, 1202, Bulgaria

Location

UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry

Sofia, 1431, Bulgaria

Location

Psychiatric Hospital "Sveti Ivan"

Zagreb, 10090, Croatia

Location

LTD Psychoeurological Hospital of Daugavpils

Daugavpils, LV-5417, Latvia

Location

SLLC Riga Centre of Psychiatry and Narcology

Riga, LV-1005, Latvia

Location

SLLC Psychoneurological Hospital of Strenci

Strenči, LV-4730, Latvia

Location

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

Arkhangelsk, 163530, Russia

Location

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

Engel's, 413124, Russia

Location

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

Moscow, 117152, Russia

Location

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

Moscow, 141371, Russia

Location

State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary

Saint Petersburg, 188820, Russia

Location

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

Saint Petersburg, 190005, Russia

Location

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

Saint Petersburg, 192019, Russia

Location

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

Saint Petersburg, 192019, Russia

Location

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

Saint Petersburg, 197341, Russia

Location

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

Saratov, 410028, Russia

Location

State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia

Saratov, 410060, Russia

Location

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

Stavropol, 357034, Russia

Location

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

Tomsk, 634014, Russia

Location

Clinic of Psychiatry, Clinical Center of Serbia,

Belgrade, 11000, Serbia

Location

Clinic of Psychiatry, Clinical Center of Serbia

Belgrade, 11000, Serbia

Location

Clinical Center "Dr Dragisa Misovic- Dedinje"

Belgrade, 11000, Serbia

Location

Special Hospital for Psychiatric Diseases "Kovin"

Kovin, 26220, Serbia

Location

Special Neuropsychiatric Hospital Kovin

Kovin, 26220, Serbia

Location

Clinic of Psychiatry, clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

University Clinical Center Kragujevac, Clinic of Psychiatry

Kragujevac, 34000, Serbia

Location

University Clinical Center Nis, Clinic of Psychiatry

Niš, 18000, Serbia

Location

Special Hospital for Psychiatric Disease Sveti Vracevi

Novi Kneževac, 23330, Serbia

Location

Special Hospital for Psychiatric Diseases "SVeti Vracevi"

Novi Kneževac, 23330, Serbia

Location

Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"

Vršac, 26300, Serbia

Location

46 Academician Pavlov St

Kharkiv, 61068, Ukraine

Location

State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry

Kharkiv, 61068, Ukraine

Location

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, 73488, Ukraine

Location

Kyev Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian railway" Department of Psychoneurology

Kyiv, 01030, Ukraine

Location

National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients

Kyiv, 01133, Ukraine

Location

Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2

Kyiv, 08631, Ukraine

Location

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, 08631, Ukraine

Location

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, 08631, Ukraine

Location

Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20

Lviv, 79021, Ukraine

Location

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, 21005, Ukraine

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study

Study Record Dates

• First Submitted: September 13, 2019
• First Posted: September 17, 2019
• Study Start: September 30, 2019
• Primary Completion: June 14, 2023
• Study Completion: June 14, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

SE (11); US (18); CR (1); LA (3); UA (10); BU (6); RU (13)