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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
NameTimeMethod
The primary endpoint for this study will be the change from baseline in total MADRS score at Day 56.
Secondary Outcome Measures
NameTimeMethod
Change from baseline in SDS total score at Day 56
Change from baseline in CGI-S score at Day 56

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