NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Purpose
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.
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.
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)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental NBI-1065845 |
NBI-1065845 administered orally once a day. |
|
|
Placebo Comparator Placebo |
Placebo identical in appearance to NBI-1065845 will be administered orally once a day. |
|
Recruiting Locations
Neurocrine Clinical Site
Chino, California 91710
Chino, California 91710
Neurocrine Clinical Site
Los Angeles, California 90025
Los Angeles, California 90025
Neurocrine Clinical Site
Stanford, California 94305
Stanford, California 94305
Neurocrine Clinical Site
Aurora, Colorado 80045
Aurora, Colorado 80045
Neurocrine Clinical Site
Maitland, Florida 32751
Maitland, Florida 32751
Neurocrine Clinical Site
Miami, Florida 33136
Miami, Florida 33136
Neurocrine Clinical Site
Cedarhurst, New York 11516
Cedarhurst, New York 11516
Neurocrine Clinical Site
New York, New York 10128
New York, New York 10128
Neurocrine Clinical Site
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
More Details
- NCT ID
- NCT06963021
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences