A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences
- Enrollment
- 550
- Locations
- 60
- Primary Endpoint
- Time from Randomization to Relapse
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
The study consists of a non-randomized open-label treatment period and a randomized double-blind maintenance period.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
Randomized Double-blind Maintenance Period: Placebo
Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period.
Intervention: Placebo (Drug)
Open-label Treatment Period: NBI-1065845
Participants will be treated with NBI-1065845 during the open-label treatment period.
Intervention: NBI-1065845 (Drug)
Randomized Double-blind Maintenance Period: NBI-1065845
Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period.
Intervention: NBI-1065845 (Drug)
Outcomes
Primary Outcomes
Time from Randomization to Relapse
Time Frame: From randomization to the earliest of relapse or end-of study (up to approximately 32 months)
Secondary Outcomes
No secondary outcomes reported