Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05848700
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2023-04-27
Brief Title:
A Clinical Study to Learn if SEP-363856 Has Physical Dependence in Adults With Schizophrenia
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
A Double-Blind Placebo-Controlled Randomized Withdrawal Study to Evaluate SEP-363856 Physical Dependence in Adult Subjects With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Clinical Study to learn if SEP-363856 has physical dependence in adults with schizophrenia This study will be held in approximately 6 study sites in the United States It will be accepting male and female participants age 18 years to 65 years Participation will be up to approximately10 weeks
Detailed Description:
This is a double-blind placebo-controlled randomized withdrawal study comparing abrupt discontinuation of SEP-363856 SEP-363856 switched to placebo to continuous SEP-363856 treatment in male and female adult subjects with schizophrenia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None