NBI-1065845-MDD3025: 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
Huntsville, Alabama 35801
Huntsville, Alabama 35801
Neurocrine Clinical Site
Bryant, Arkansas 72022
Bryant, Arkansas 72022
Neurocrine Clinical Site
Glendale, California 91206
Glendale, California 91206
Neurocrine Clinical Site
Redlands, California 92373
Redlands, California 92373
Neurocrine Clinical Site
San Francisco, California 94107
San Francisco, California 94107
Neurocrine Clinical Site
Hollywood, Florida 33024
Hollywood, Florida 33024
Neurocrine Clinical Site
Tampa, Florida 33634
Tampa, Florida 33634
Neurocrine Clinical Site
Atlanta, Georgia 30318
Atlanta, Georgia 30318
Neurocrine Clinical Site
New York, New York 10029
New York, New York 10029
Neurocrine Clinical Site
Mason, Ohio 45040
Mason, Ohio 45040
Neurocrine Clinical Site
DeSoto, Texas 75115
DeSoto, Texas 75115
Neurocrine Clinical Site
Charlottesville, Virginia 22903
Charlottesville, Virginia 22903
More Details
- Status
- Recruiting
- Sponsor
- Neurocrine Biosciences