Recruiting
Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
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.
ClinicalTrials.gov IDNCT06786624
PhasePHASE3
Enrollment200
SponsorNeurocrine Biosciences
Age18 Years
SexALL
Conditions studied
Major Depressive Disorder
About this study
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.
Interventions
- Drug: NBI-1065845 — NBI-1065845 tablets
- Drug: Placebo — Matching placebo tablets
Primary outcomes
- Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56 (Baseline, Day 56)
Eligibility information
Key Inclusion Criteria:
* Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
* Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
* Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
* Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
Key Exclusion Criteria:
* A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
* Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
* Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.
Study locations
- Neurocrine Clinical Site, Little Rock, Arkansas 72204 United States
- Neurocrine Clinical Site, Garden Grove, California 92844 United States
- Neurocrine Clinical Site, Orange, California 92866 United States
- Neurocrine Clinical Site, Pico Rivera, California 90660 United States
- Neurocrine Clinical Site, San Diego, California 92103 United States
- Neurocrine Clinical Site, Upland, California 91786 United States
- Neurocrine Clinical Site, Hollywood, Florida 33024 United States
- Neurocrine Clinical Site, Maitland, Florida 32751 United States
- Neurocrine Clinical Site, Boston, Massachusetts 02116 United States
- Neurocrine Clinical Site, Watertown, Massachusetts 02472 United States
Showing 10 of 18 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.