Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Recruiting · NCT06786624 · Interventional (participants receive a specific treatment) · Lead sponsor: Neurocrine Biosciences
View the official record on ClinicalTrials.gov →Interventions studied
NBI-1065845Placebo
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
- Key
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.
Where it is running
18 locations listed across 8 US states.
- Neurocrine Clinical Site - Little Rock, Arkansas, United States
- Neurocrine Clinical Site - Garden Grove, California, United States
- Neurocrine Clinical Site - Orange, California, United States
- Neurocrine Clinical Site - Pico Rivera, California, United States
- Neurocrine Clinical Site - San Diego, California, United States
- Neurocrine Clinical Site - Upland, California, United States
- Neurocrine Clinical Site - Hollywood, Florida, United States
- Neurocrine Clinical Site - Maitland, Florida, United States
- Neurocrine Clinical Site - Boston, Massachusetts, United States
- Neurocrine Clinical Site - Watertown, Massachusetts, United States
- Neurocrine Clinical Site - Mount Kisco, New York, United States
- Neurocrine Clinical Site - Avon Lake, Ohio, United States
- Neurocrine Clinical Site - Westlake, Ohio, United States
- Neurocrine Clinical Site - Dallas, Texas, United States
- Neurocrine Clinical Site - Houston, Texas, United States
- Neurocrine Clinical Site - Richmond, Texas, United States
- Neurocrine Clinical Site - The Woodlands, Texas, United States
- Neurocrine Clinical Site - Everett, Washington, United States