Clinical trial NCT04092686: A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: acute psychosis
Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-17
Enrollment: 464
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, parallel-group, placebo-controlled, fixed-dose, multicenter study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Baseline in Positive and negative syndrome scale (PANSS) total score at Endpoint (Week 6)
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change from Baseline in Clinical Global Impressions - Severity (CGI-S) score at Endpoint (Week 6)
timeFrame: Baseline and Week 6
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Woodland Research Northwest
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Bellflower
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Culver City
country: United States
facility: ProScience Research Group
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network
state: California
city: San Diego
country: United States
facility: California Neuropsychopharmacology Clinical Research Institute
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Hollywood
country: United States
facility: Larkin Behavioral Health Services
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I-IV, INC.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Chicago
country: United States
facility: Pillar Clinical Research
state: Illinois
city: Lake Charles
country: United States
facility: Lake Charles Clinical Trials
state: Louisiana
city: Gaithersburg
country: United States
facility: CBH Health, LLC
state: Maryland
city: Saint Louis
country: United States
facility: Arch Clinical Trials, LLC
state: Missouri
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Richardson
country: United States
facility: Pillar Clinical Research
state: Texas
city: Burgas
country: Bulgaria
facility: Mental Health Centre, Prof. Dr. Ivan Temkov, Burgas EOOD, Department for Treatment of Emergency Psychiatric Conditions
city: Kardzhali
country: Bulgaria
facility: State Psychiatric Hospital - Kardzhali, First Woman Department, Third Men Deparment
city: Novi Iskar
country: Bulgaria
facility: State Psychiatric Hospital Sv. Ivan rilski-Department General Psychiatry for Adults "closed" Type -Men, Department General Psychiatry for Adults, "Closed" Type - Women
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi EAD
city: Sofia
country: Bulgaria
facility: Mental Health Center - Sofia EOOD Unit for Active Treatment of Persons with Serious Mental Disorders
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska EAD Second Department of Pshychiatry at Clinic of Psychiatry
city: Zagreb
country: Croatia
facility: Psychiatric Hospital "Sveti Ivan"
city: Daugavpils
country: Latvia
facility: LTD Psychoeurological Hospital of Daugavpils
city: Riga
country: Latvia
facility: SLLC Riga Centre of Psychiatry and Narcology
city: Strenci
country: Latvia
facility: SLLC Psychoneurological Hospital of Strenci
city: Arkhangelsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of Arkhangelsk region "Arkhangelsk clinical psychiatric hospital"
city: Engels
country: Russian Federation
facility: State Healthcare Institution "Psychiatric Hospital of Engels" of MoH of Saratov Region, departments № 1 and 3, 166
city: Leningrad
country: Russian Federation
facility: State Public Institution of Healthcare Leningrad Regional Psychoneurological Dispensary
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Moscow "Psychiatric Clinical Hospital #1 named after N.A. Alekseev of Department of Healthcare of Moscow
city: Moscow
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Moscow "Psychiatric Hospital No. 5"
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko, inpatient No 2 leg add
city: Saint Petersburg
country: Russian Federation
facility: FSBI- "NMRC of Psychiatry and Neurology named after V.M. Bekhterev" MoH RF3
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Public Institution of Healthcare "City Psychiatric Hospital #3 named after I.I. Skvortsov-Stepanov"
city: Saratov
country: Russian Federation
facility: State Institution of Healthcare "Saratov City Clinical Hospital #2 named after V.I. Razumovskiy" 20 and 21 departments
city: Saratov
country: Russian Federation
facility: State Institution of Healthcare Regional Clinical Psychiatric Hospital of Saint Sofia
city: St. Petersburg
country: Russian Federation
facility: FSBI "NMRC of Psychiatry and Neurology named after V.M. Bekterev" MoH RF
city: Stavropol
country: Russian Federation
facility: State Budgetary Healthcare Institution of Stavropol region "Stavropol Region Psychiatric Hospital # 2"
city: Tomsk
country: Russian Federation
facility: Federal State Budgetary Scientific Institution "Tomsk National Research Medical Center of Russian Academy of Sciences",
city: Belgrade
country: Serbia
facility: Clinic of Psychiatry, Clinical Center of Serbia,
city: Belgrade
country: Serbia
facility: Clinic of Psychiatry, Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Center "Dr Dragisa Misovic- Dedinje"
city: Kovin
country: Serbia
facility: Special Hospital for Psychiatric Diseases "Kovin"
city: Kovin
country: Serbia
facility: Special Neuropsychiatric Hospital Kovin
city: Kragujevac
country: Serbia
facility: Clinic of Psychiatry, clinical Center Kragujevac
city: Kragujevac
country: Serbia
facility: University Clinical Center Kragujevac, Clinic of Psychiatry
city: Nis
country: Serbia
facility: University Clinical Center Nis, Clinic of Psychiatry
city: Novi Knezevac
country: Serbia
facility: Special Hospital for Psychiatric Disease Sveti Vracevi
city: Novi Knezevac
country: Serbia
facility: Special Hospital for Psychiatric Diseases "SVeti Vracevi"
city: Vrsac
country: Serbia
facility: Special Hospital for Psychiatric Diseases "Dr Slavoljub Bakalovic"
city: Kharkiv
country: Ukraine
facility: 46 Academician Pavlov St
city: Kharkiv
country: Ukraine
facility: State Institution Institute of Neurology, Psychiatry and Narcology of the National Academy of Medical Sciences of Ukraine, Department of Boundary Psychiatry
city: Kherson
country: Ukraine
facility: Communica Noncommercial Enterprise Kherson Regional Institution of Psychiatric Care Assistance of Kherson Regional Council, Male Department of Psychiatry #3, Female Department of Psychiatry #10
city: Kyiv
country: Ukraine
facility: Kyev Clinical Hospital on Railway Station #1 of Healthcare Center branch of JSC "Ukrainian railway" Department of Psychoneurology
city: Kyiv
country: Ukraine
facility: National Military and Medical Clinical Center, The Main Military Clinical Hospital, Psychiatric Clinic with Wards for Narcological Patients
city: Kyiv
country: Ukraine
facility: Communal Institution of Kyiv Regional Council Regional Psychiatric and Narcological Medical Association, Male Department #10, Female Department #2
city: Kyiv
country: Ukraine
facility: Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4 ,
city: Kyiv
country: Ukraine
facility: Communal Non-commercial Enterprise Kyiv City Psychoneurological Hospital #3 of Executive Body of Kyiv City Council (Kyiv City State Administration), General Psychiatric Department #4
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Concil Lviv Regional Clinical Psychiatric Hospital, Department #20
city: Vinnytsia
country: Ukraine
facility: 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
Study officials:
References: