Recruiting
A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
ClinicalTrials.gov IDNCT07196501
PhasePHASE3
Enrollment550
SponsorNeurocrine Biosciences
Age18 Years
SexALL
Conditions studied
Major Depressive Disorder
About this study
The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.
Interventions
- Drug: NBI-1065845 — Oral tablet
- Drug: Placebo — Oral tablet
Primary outcomes
- Time from Randomization to Relapse (From randomization to the earliest of relapse or end-of study (up to approximately 32 months))
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.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Study locations
- Neurocrine Clinical Site, Oceanside, California 92056 United States
- Neurocrine Clinical Site, Orange, California 92868 United States
- Neurocrine Clinical Site, San Jose, California 95124 United States
- Neurocrine Clinical Site, New Haven, Connecticut 06520 United States
- Neurocrine Clinical Site, Miami Gardens, Florida 33014 United States
- Neurocrine Clinical Site, Orlando, Florida 32803 United States
- Neurocrine Clinical Site, Palm Bay, Florida 32905 United States
- Neurocrine Clinical Site, Tampa, Florida 33629 United States
- Neurocrine Clinical Site, Iowa City, Iowa 52242 United States
- Neurocrine Clinical Site, Marrero, Louisiana 70072 United States
Showing 10 of 60 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.