Trials / Recruiting
RecruitingNCT06963021
NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBI-1065845 | NBI-1065845 tablets |
| DRUG | Placebo | Matching placebo tablets |
Timeline
- Start date
- 2025-05-30
- Primary completion
- 2027-07-01
- Completion
- 2027-07-01
- First posted
- 2025-05-08
- Last updated
- 2026-04-15
Locations
30 sites across 7 countries: United States, Belgium, Canada, Finland, Hungary, Latvia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06963021. Inclusion in this directory is not an endorsement.