An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
NCT ID: NCT02970929
Last Updated: 2024-07-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
157 participants
INTERVENTIONAL
2017-01-31
2019-01-29
Brief Summary
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Detailed Description
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No statistical hypothesis tests will be performed.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SEP-363856
SEP-363856 capsule (25 mg, 50 mg, or 75 mg) once daily
SEP-363856
One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks
Interventions
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SEP-363856
One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
40 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Woodland International research Group
Little Rock, Arkansas, United States
CNRI-Los Angeles, LLC
Pico Rivera, California, United States
UCSD Medical Center UCSD Department of Psychiatry
San Diego, California, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Kashinath Yadalam
Lake Charles, Louisiana, United States
Pillar Clinical Research, LLC
Dallas, Texas, United States
Bugát Pál Kórház-Rendelőintézet, Rehabilitációs Elmegyógyászati Osztály
Gyöngyös, Dózsa György, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Pszichiatriai Osztaly
Gyula, , Hungary
Spitalul Universitar de Urgenta Militar Central "Dr. Carol Davila"
Bucharest, , Romania
Centrul de Evaluarea si Tratament al Toxicodependentelor pentru Tineri "Sf. Stelian", Sectia Psihiatrie
Bucharest, , Romania
spitalul Clinic de Neuropsihiatrie Craiova ,Clinica II Psihiatrie
Craiova, , Romania
Institutul de Psihiatrie Socola Iasi, Sectia Psihiatrie III Acuti
Iași, , Romania
St-Petersburg SHI Psychiatrical hospital #1 n.a. Kaschenko
Gatchina, , Russia
City Psychiatric Hospital of St. Nikolay Chudotvorets
Saint Petersburg, , Russia
FB=SBI"Saint Petersburg Scientific and Research Psychoneurological Institute n.a. V.M. Bekhterev"
Saint Petersburg, , Russia
SPHI "City Mental Hospital #3 n.a. I.I.Skvortsov-Stepanov"
Saint Petersburg, , Russia
SPb SBIH "City Psychoneurological Dispensary #7 (with inpatient facilities)"
Saint Petersburg, , Russia
SHI Regional Clinical Psychiatry Hospital of St. Sofia
Saratov, , Russia
FSBEI HE "Smolensk State Medical University" of the MoH of the RF
Smolensk, , Russia
Sverdlov Regional Psychiatric Clinical Hospital
Yekaterinburg, , Russia
Regional Psychoneurological Hospital #3, Dept of Crisis Cond & Primary Psych Episode #1
Ivano-Frankivsk, , Ukraine
CHI Kharkiv RCPH#3 Center of Emerg PsychSI Inst of Neur, Psych & Narc of NAMSU, Unit of Emergency Psychiatry and Narcology
Kharkiv, , Ukraine
CHI Kharkiv Regional Clinical Psychiatric Hospital #3, Psychiatric Department of Primary Psychotic Episod
Kharkiv, , Ukraine
CI Kherson Regional Psychiatric Hospital of Kherson RC
Kherson, , Ukraine
TMA Psychiatry in Kyiv Center of NT & Rehabilitation of Psychotic Conditions
Kyiv, , Ukraine
CI Odesa Regional Medical Center of Mental Health
Odesa, , Ukraine
CI Cherkasy Regional Psychiatric Hospital of ChRC, Femail Dept #11, Male Dept #12
Smila, , Ukraine
Ternopil RCCPH Depts of Psychiatry #2 (m) & Psychiatry #6 Ternopil I.ya. Gorbachevskyi SMU
Ternopil, , Ukraine
Transcarpathian Regional Narcological Dispensary
Uzhhorod, , Ukraine
CI O.I. Yuschenko VRPsH Depts #7 & #10 M.I. Pyrogov VNMU
Vinnytsia, , Ukraine
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-001556-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SEP361-202
Identifier Type: -
Identifier Source: org_study_id
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