An Extension Study of Safety and Tolerability of SEP-363856 in Adult Subjects With Schizophrenia
Completed · Phase 2
Conditions studied: Schizophrenia
In brief
An extension study of safety and tolerability of SEP-363856 in adult subjects with schizophrenia
Key facts
- Study ID
- NCT02970929
- Run by
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- People needed
- 157
- Starts
- 2017-01-31
- Expected to finish
- 2019-01-29
- Last updated by the study team
- 2024-07-05
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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