A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Neurocrine Biosciences
Summary
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.
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
Oral tablet
- DrugPlacebo
Oral tablet
Locations (45)
- Neurocrine Clinical SiteOceanside, California
- Neurocrine Clinical SiteSan Jose, California
- Neurocrine Clinical SiteNew Haven, Connecticut
- Neurocrine Clinical SiteMiami Gardens, Florida
- Neurocrine Clinical SiteOrlando, Florida
- Neurocrine Clinical SitePalm Bay, Florida