A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Neurocrine Biosciences
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key 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 a…
Interventions
- DrugNBI-1065845
NBI-1065845 tablets
- DrugPlacebo
Matching placebo tablets
Locations (10)
- Neurocrine Clinical SiteHuntsville, Alabama
- Neurocrine Clinical SiteGlendale, California
- Neurocrine Clinical SiteIrvine, California
- Neurocrine Clinical SiteMiami, Florida
- Neurocrine Clinical SiteTampa, Florida
- Neurocrine Clinical SiteAtlanta, Georgia