Clinical trial NCT02970929: An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Official title: A 26-Week Open-label Safety and Tolerability Extension Study of SEP-363856 in Adult Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-22
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia

Detailed description: This is a 26 week, multiregional, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 for the treatment of subjects with schizophrenia who have completed the 4 week double-blind treatment phase of Study SEP361-201 (NCT02969382) Subjects received open-label SEP-363856 50 mg/day from Day 1 through Day 3, and then received flexible dosing of SEP-363856 (25, 50, or 75 mg/day) for the rest of the trial.

No statistical hypothesis tests will be performed.

Eligibility criteria: Inclusion Criteria:

Subject must give written informed consent and privacy authorization prior to participation in the study and able to comply with the protocol, in the opinion of the investigator.

* Subject has completed Study SEP361 201 through Week 4
* Subject has not taken any medication other than the study drug for the purpose of controlling schizophrenia symptoms during Study SEP361 201.
* Female subject must have a negative urine pregnancy test at Visit 7 of Study SEP361 201; females who are post-menopausal (defined as at least 12 months of spontaneous amenorrhea) and those who have undergone hysterectomy or bilateral oophorectomy will be exempted from the pregnancy test.
* Male subjects with female partner(s) of childbearing potential must agree to avoid fathering a child and use acceptable methods of birth control from screening until at least 30 days after the last study drug administration

Exclusion Criteria:

* 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 Visit 7 of Study SEP361 201. Subjects who answer "yes" to this question must be referred to the Investigator for follow up evaluation.
* Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at Visit 7 of Study SEP361 201 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
* Subject has a positive urine drug screen (UDS) or breath alcohol test at Visit 7 of Study SEP361 201.
* Subject is pregnant or lactating.
* Subject is at high risk of non-compliance in the Investigator's opinion.
* Subject is in the opinion of the Investigator, unsuitable in any other way to participate in this study.

Primary outcomes:
measure: The Incidence of Overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Discontinuation
timeFrame: From first dose of study drug to last study visit (27 weeks)
Secondary outcomes:
measure: Frequency of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
timeFrame: Overall post Open-label Baseline treatment period (26 weeks)
measure: Severity of Suicidal Ideation (SI) and Suicidal Behavior (SB) Using the Columbia - Suicide Severity Rating Scale (C-SSRS)
timeFrame: Overall post Open-label Baseline treatment period (26 weeks)
measure: Time to Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856
timeFrame: From the time of clinical response to relapse or censor (one day after the last study drug dose)
measure: Rate of Relapse During the 26-week Open-label Treatment Period for Subjects Who Demonstrated a Clinical Response to 4 Weeks of Treatment With SEP-363856
timeFrame: From the time of clinical response to relapse or censor (one day after the last study drug dose)
measure: Changes From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Positive and Negative Syndrome Scale (PANSS) Total Score and Subscale Scores (Positive, Negative, and General Psychopathology)
timeFrame: Double-blind Baseline (DB BLN), Open-label Baseline (OL BLN), Week 26 (Wk 26)
measure: Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Clinical Global Impression - Severity (CGI-S) Score
timeFrame: Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
measure: Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Brief Negative Symptom Scale (BNSS) Total Score
timeFrame: Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
measure: Change From Double-blind Baseline of Study SEP361-201 and Open-label Baseline of Study SEP361-202 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: Double-blind (DB) Baseline, Open-label (OL) Baseline, Week 26
measure: Proportion of Subjects Who Achieved a Response, Defined as a 20% or Greater Improvement in Positive and Negative Syndrome Scale (PANSS) Total Score From Double-blind Baseline of Study SEP361-201
timeFrame: Week 26
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Woodland International research Group
state: Arkansas
city: Pico Rivera
country: United States
facility: CNRI-Los Angeles, LLC
state: California
city: San Diego
country: United States
facility: UCSD Medical Center UCSD Department of Psychiatry
state: California
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research
state: Georgia
city: Lake Charles
country: United States
facility: Kashinath Yadalam
state: Louisiana
city: Dallas
country: United States
facility: Pillar Clinical Research, LLC
state: Texas
city: Gyongyos
country: Hungary
facility: Bugát Pál Kórház-Rendelőintézet, Rehabilitációs Elmegyógyászati Osztály
state: Dózsa György
city: Gyula
country: Hungary
facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly
city: Bucuresti
country: Romania
facility: Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
city: Bucuresti
country: Romania
facility: Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri "Sf. Stelian", Sectia Psihiatrie
city: Craiova
country: Romania
facility: spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie
city: Iasi
country: Romania
facility: Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
city: Ekaterinburg
country: Russian Federation
facility: Sverdlov Regional Psychiatric Clinical Hospital
city: Gatchina
country: Russian Federation
facility: St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko
city: Saint-Petersburg
country: Russian Federation
facility: SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
city: Saratov
country: Russian Federation
facility: SHI Regional Clinical Psychiatry Hospital of St. Sofia
city: Smolensk
country: Russian Federation
facility: FSBEI HE "Smolensk State Medical University" of the MoH of the RF
city: St. Petersburg
country: Russian Federation
facility: City Psychiatric Hospital of St. Nikolay Chudotvorets
city: St. Petersburg
country: Russian Federation
facility: FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev"
city: St. Petersburg
country: Russian Federation
facility: SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)"
city: Ivano Frankivsk
country: Ukraine
facility: Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1
city: Kharkiv
country: Ukraine
facility: CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology
city: Kharkiv
country: Ukraine
facility: CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod
city: Kherson
country: Ukraine
facility: CI Kherson Regional Psychiatric Hospital of Kherson RC
city: Kyiv
country: Ukraine
facility: TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions
city: Odesa
country: Ukraine
facility: CI Odesa Regional Medical Center of Mental Health
city: Smila
country: Ukraine
facility: CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12
city: Ternopil
country: Ukraine
facility: Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU
city: Uzhgorod
country: Ukraine
facility: Transcarpathian Regional Narcological Dispensary
city: Vinnytsia
country: Ukraine
facility: CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU
Study officials:
References: