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
Los Angeles 5368361, California 5332921 90025
Los Angeles 5368361, California 5332921 90025
Neurocrine Clinical Site
Aurora 5412347, Colorado 5417618 80045
Aurora 5412347, Colorado 5417618 80045
Neurocrine Clinical Site
Cromwell 4832121, Connecticut 4831725 06416
Cromwell 4832121, Connecticut 4831725 06416
Neurocrine Clinical Site
Farmington 4834272, Connecticut 4831725 06030
Farmington 4834272, Connecticut 4831725 06030
Neurocrine Clinical Site
Maitland 4163220, Florida 4155751 32751
Maitland 4163220, Florida 4155751 32751
Neurocrine Clinical Site
Tampa 4174757, Florida 4155751 33613
Tampa 4174757, Florida 4155751 33613
Neurocrine Clinical Site
Gaithersburg 4355843, Maryland 4361885 20877
Gaithersburg 4355843, Maryland 4361885 20877
Neurocrine Clinical Site
Cedarhurst 5111974, New York 5128638 11516
Cedarhurst 5111974, New York 5128638 11516
Neurocrine Clinical Site
New York 5128581, New York 5128638 10029
New York 5128581, New York 5128638 10029
Neurocrine Clincial Site
New York 5128581, New York 5128638 10128
New York 5128581, New York 5128638 10128
More Details
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences