Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT06786624Phase 3Recruiting

Lead sponsor
Neurocrine Biosciences (Industry)
Enrollment
200 (estimated)
Start date
22 Jan 2025
Primary completion
Jul 2027 (estimated)
Study completion
1 Jul 2027
Last update posted
29 Oct 2025

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
Quadruple
Arms
2

Interventions

  • NBI-1065845 Drug
  • Placebo Drug

Conditions and primary outcome

  • Major Depressive Disorder

Primary outcome

Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56 (Baseline, Day 56)

Posted results on ClinicalTrials.gov

Results posted on ClinicalTrials.gov: No

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

No PubMed citation lists NCT06786624.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

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