Clinical trial NCT04115319: A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
Official title: A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-04
Enrollment: 475
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, Active Comparator-Controlled Study
Primary purpose: TREATMENT

Brief summary: A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia.

This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.

Detailed description: This is a 52-week, multicenter, randomized, double-blind, parallel-group, flexible-dose study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) compared with quetiapine XR (400 to 800 mg/day) in clinically stable adult subjects with schizophrenia. This study is projected to randomize a least 300 subjects to two treatment groups (SEP-363856 50 to 100 mg/day or quetiapine XR 400 to 800 mg/day) in a 2:1 ratio. Study drug will be taken once a day and may be taken without food or with a light meal.

Eligibility criteria: Inclusion criteria:

The main inclusion criteria include, but are not limited to the following:

* Male or female subject between 18 to 65 years of age (inclusive) at the time of consent.
* Subject meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview at screening (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the subject's diagnosis must be ≥ 1 year prior to Screening.
* Subject must have a CGI-S score ≤ 4 at Screening and Baseline.
* Subject must have a PANSS total score ≤ 80 at Screening and Baseline.
* Subject is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening.
* Subject has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening.
* Subjects taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator).
* Subject is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis).

Exclusion criteria:

Main exclusion criteria include, but are not limited to:

* Subject was hospitalized for a psychiatric illness within the 8 weeks prior to Screening.
* Subject has a current 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, schizoaffective disorder, ,bipolar I or II disorder, obsessive compulsive disorder, and posttraumatic stress disorder, symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as theses symptoms are not the primary focus of treatment.
* Subject is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at adequate dose as per labeling, for at least 4 weeks.
* Subject answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Screening (i.e., in the past one month) or at Baseline (i.e., since last visit).
* Subject is at significant risk of harming self or others based on Investigator's judgment.
* Subject has attempted suicide within 6 months prior to Screening.
* Subject has received treatment with a psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer)
* Subject has been treated with quetiapine or quetiapine XR within the 6 weeks prior to Screening or has a history of inadequate response or intolerability to quetiapine or quetiapine XR.
* 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.
* Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

Primary outcomes:
measure: The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation
timeFrame: 52 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Synexus Clinical Research US, Inc.
state: California
city: Oakland
country: United States
facility: Pacific Research Partners
state: California
city: Oceanside
country: United States
facility: Excell Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Network
state: California
city: Miami Lakes
country: United States
facility: Innovative Clinical Research
state: Florida
city: Miami
country: United States
facility: Premier Clinical Research Institute
state: Florida
city: Atlanta
country: United States
facility: Synexus Clinical Research US
state: Georgia
city: Hoffman Estates
country: United States
facility: Alexian Brothers Center for Psychiatric Research
state: Illinois
city: Lincolnwood
country: United States
facility: Pillar Clinical Research
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Clinical Research
state: Louisiana
city: Saint Louis
country: United States
facility: PsychCare Consultants Research
state: Missouri
city: Las Vegas
country: United States
facility: Dean-Yurie, Altea Research
state: Nevada
city: Cedarhurst
country: United States
facility: Krzsztof Wroblewi-Neurobehavioral Research Inc.
state: New York
city: Jamaica
country: United States
facility: Tyne Moeller-Synexus Clinical Research US Inc.
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Charlotte
country: United States
facility: New Hope Clinical Research
state: North Carolina
city: North Canton
country: United States
facility: Dr. Shishuka Malhorta
state: Ohio
city: Brasov
country: Romania
facility: Spitalul de Psihiatrie si Neurologie Brasov, Sectia Psihiatrie Clinica III, Str. Mihai Eminescu,
city: Brasov
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila", Sectia Psihiatrie
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie "Prof. Dr. Alexandru Obregia", Sectia Psihiatrie XII
city: Bucuresti
country: Romania
facility: Centrul de Evaluare si Tratament al Toxicodependentelor pentru Tineri "Sfantul Stelian",
city: Bucuresti
country: Romania
facility: Spitalul Clinic de Psihiatrie Prof. Dr. Alexandru Obregia, Sectia Clinica Psihiatrie XIII
city: Iasi
country: Romania
facility: Institutul de Psihiatrie Socola Iasi
city: Arkhangelsk
country: Russian Federation
facility: State Budgetary Institution of Healthcare "Arkhangelsk Regional Clinical Psychiatric Hospital"
city: Ekaterinburg
country: Russian Federation
facility: State Budgetary Institution of Heathcare of Sverdlovsk Region "Sverdlovsk Regional Clinical Psychiatric Hospital"
city: Leningrad
country: Russian Federation
facility: Saint Petersburg State Budgetary Institution of Healthcare "Psychiatric Hospital named after P.P. Kashchenko"
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Central Clinical Psychiatric Hospital"
city: Omsk
country: Russian Federation
facility: Budgetary Institution of Healthcare of Omsk region "Clinical Psychiatric Hospital n.a. N.N. Solodovnikov"
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Public Institution of Healthcare "Psychiatric Hospital of Saint Nikolai Chudotvorets"
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev" MoH RF
city: Saint Petersburg
country: Russian Federation
facility: Federal State Budgetary Institution "National Medical Research Center of Psychiatry and Neurology n.a. V.M. Bekhterev"
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Institution of Healthcare "City Psychoneurological Dispensary #5"
city: Saint Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Institution of Healthcare "Psychoneurological Dispensay No 1"
city: Smolensk
country: Russian Federation
facility: FSBEI HE "Smolensk State Medical University" of the MoH of the RF leg add: 28, Krupskoi str, Smolensk, Smolensk region, 214019; act add: 46-a, Kirova str, Smolensk
city: St-Petersburg
country: Russian Federation
facility: S St-Petersburg state budget institution Psychoneurological dispensary #10
city: Stavropol
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Stavropol territory "Regional Specialization Psychiatry Hospital # 2"
city: Tomsk
country: Russian Federation
facility: LLC "Clinic Stolet" 30, Derbyshevskiy lane, Tomsk, Tomsk region, 634009, Russia based on FSBSI "Tomsk National Research Medical Center of Russian Academy of Sciences"
city: Yaroslavl
country: Russian Federation
facility: State Budgetary Institution of Healthcare of Yaroslavl region "Yaroslavl Regional Clinical Psychiatric Hospital"
city: Ivano-Frankivsk
country: Ukraine
facility: Communal Non-commercial Enterprise Carpathian Regional Clinical Center of Mental Health of Ivano-Frankivsk Regional Council, Department of Neuroses and Edge Conditions/States #8
city: Kharkiv
country: Ukraine
facility: State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Clinical, Social and Child Psychiatry
city: Kharkiv
country: Ukraine
facility: State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Unit of Emergency Psychiatry and Narcology
city: Kyiv
country: Ukraine
facility: Kyiv Clinical Hospital on Railway Transport #2 of Healthcare Center branch of JSC "Ukrainian Railway", Consultative and Diagnostic Center of Policlinic
city: Smila
country: Ukraine
facility: Communal Noncommercial Enterprise Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council, Female Department #11, Male Department #12
city: Ternopil
country: Ukraine
facility: Communal Non-commercial Enterprise Ternopil Regional Clinical Psychoneurological Hospital of Ternopil Regional Council, Department of Psychiatry #2 (male), Department of Psychiatry #6 (female), Ternopil I.Ya. Gorbachevskyi National Medical University of t
city: Uzhgorod
country: Ukraine
facility: Communal Noncommercial Enterprise Transcarpathian Regional Medical Center of Mental Health and Medicine of Addictions of Transcarpathian Regional Council, Department of Psychiatry
Study officials:
References: