Study to assess the efficacy and safety of adjunctive NBI-1065845 in adults with Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Registration Number
- 2024-519418-29-00
- Lead Sponsor
- Neurocrine Biosciences Inc.
- Brief Summary
The primary objective for this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in subjects with MDD on improving symptoms of depression, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.
- Secondary Outcome Measures
Name Time Method Change from baseline in SDS total score at Day 56 Change from baseline in CGI-S score at Day 56