Clinical trial NCT04072354: A Clinical Trial to 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: 2019-08-28
Enrollment: 463
Sex: ALL
Minimum age (years): 13
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 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.

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 (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.

Eligibility criteria: 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.

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