Trials / Recruiting
RecruitingNCT06966401
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- Sponsor
- Neurocrine Biosciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | NBI-1065845 | NBI-1065845 tablets |
Timeline
- Start date
- 2025-04-16
- Primary completion
- 2029-05-01
- Completion
- 2030-05-01
- First posted
- 2025-05-11
- Last updated
- 2025-08-01
Locations
18 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06966401. Inclusion in this directory is not an endorsement.