A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Purpose
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.
Condition
- Major Depressive Disorder
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- 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.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Open-label Treatment Period: NBI-1065845 |
Participants will be treated with NBI-1065845 during the open-label treatment period. |
|
|
Experimental Randomized Double-blind Maintenance Period: NBI-1065845 |
Participants will be randomized to receive NBI-1065845 during the randomized double-blind maintenance period. |
|
|
Experimental Randomized Double-blind Maintenance Period: Placebo |
Participants will be randomized to receive matching placebo during the randomized double-blind maintenance period. |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences
