A study to evaluate the long-term safety and tolerability of SEP-363856 in subjects with schizophrenia.
- Conditions
- SchizophreniaMedDRA version: 21.1Level: LLTClassification code 10001064Term: Acute schizophreniaSystem Organ Class: 100000004873MedDRA version: 20.0Level: LLTClassification code 10008525Term: Childhood schizophreniaSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2019-000696-16-LV
- Lead Sponsor
- Sunovion Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 612
• Subject has completed the Treatment Period of Study SEP361-301 or Study SEP361-302.
• Subject has not taken any medication other than the study drug and protocol-allowed medications for the purpose of controlling schizophrenia symptoms during Study SEP361-301 or SEP361-302.
Are the trial subjects under 18? yes
Number of subjects for this age range: 57
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 555
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Subject answered 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 the EOT Visit of Study SEP361-301 or SEP361-302.
• Subject has a clinically significant abnormality including physical examination, vital signs, ECG, or laboratory test at the EOT Visit of Study SEP361-301 or SEP361-302 that the investigator in consultation with the medical monitor considers to be inappropriate to allow participation in the study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method