A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Recruiting · NCT07196501 · 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 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.
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.
- Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
Where it is running
60 locations listed across 14 US states.
- Neurocrine Clinical Site - Oceanside, California, United States
- Neurocrine Clinical Site - Orange, California, United States
- Neurocrine Clinical Site - San Jose, California, United States
- Neurocrine Clinical Site - New Haven, Connecticut, United States
- Neurocrine Clinical Site - Miami Gardens, Florida, United States
- Neurocrine Clinical Site - Orlando, Florida, United States
- Neurocrine Clinical Site - Palm Bay, Florida, United States
- Neurocrine Clinical Site - Tampa, Florida, United States
- Neurocrine Clinical Site - Iowa City, Iowa, United States
- Neurocrine Clinical Site - Marrero, Louisiana, United States
- Neurocrine Clinical Site - O'Fallon, Missouri, United States
- Neurocrine Clinical Site - Albuquerque, New Mexico, United States
- Neurocrine Clinical Site - Glen Oaks, New York, United States
- Neurocrine Clinical Site - Charlotte, North Carolina, United States
- Neurocrine Clinical Site - Edmond, Oklahoma, United States
- Neurocrine Clinical Site - Oklahoma City, Oklahoma, United States
- Neurocrine Clinical Site - Philadelphia, Pennsylvania, United States
- Neurocrine Clinical Site - Austin, Texas, United States
- Neurocrine Clinical Site - Bellaire, Texas, United States
- Neurocrine Clinical Site - Friendswood, Texas, United States
- Neurocrine Clinical Site - Stafford, Texas, United States
- Neurocrine Clinical Site - Wichita Falls, Texas, United States
- Neurocrine Clinical Site - Draper, Utah, United States
- Neurocrine Clinical Site - Roanoke, Virginia, United States
- Neurocrine Clinical Site - Barcelona, Spain
- Neurocrine Clinical Site - Barcelona, Spain
- Neurocrine Clinical Site - Belgrade, Serbia
- Neurocrine Clinical Site - Bialystok, Poland
- Neurocrine Clinical Site - Bydgoszcz, Poland
- Neurocrine Clinical Site - Gdansk, Poland
- Neurocrine Clinical Site - Keelung, Taiwan
- Neurocrine Clinical Site - Kovin, Serbia
- Neurocrine Clinical Site - Kragujevac, Serbia
- Neurocrine Clinical Site - Milan, Italy
- Neurocrine Clinical Site - Roma, Italy
- Neurocrine Clinical Site - Rome, Italy
- Neurocrine Clinical Site - Seoul, South Korea
- Neurocrine Clinical Site - Seoul, South Korea
- Neurocrine Clinical Site - Seoul, South Korea
- Neurocrine Clinical Site - Sofia, Bulgaria
- Neurocrine Clinical Site - Sofia, Bulgaria
- Neurocrine Clinical Site - Sofia, Bulgaria
- Neurocrine Clinical Site - Sofia, Bulgaria
- Neurocrine Clinical Site - Taipei, Taiwan
- Neurocrine Clinical Site - Taipei, Taiwan
- Neurocrine Clinical Site - Taipei, Taiwan
- Neurocrine Clinical Site - Tallinn, Estonia
- Neurocrine Clinical Site - Tallinn, Estonia
- Neurocrine Clinical Site - Tartu, Estonia
- Neurocrine Clinical Site - Torino, Italy
- Neurocrine Clinical Site - Toronto, Canada
- Neurocrine Clinical Site - Calgary, Alberta, Canada
- Neurocrine Clinical Site - North Vancouver, British Columbia, Canada
- Neurocrine Clinical Site - Ansan-si, Gyeonggi-do, South Korea
- Neurocrine Clinical Site - Alcorcón, Madrid, Spain
- Neurocrine Clinical Site - Kingston, Ontario, Canada
- Neurocrine Clinical Site - Sherbrooke, Quebec, Canada
- Neurocrine Clinical Site - Carlton, Victoria, Australia
- Neurocrine Clinical Site - Melbourne, Victoria, Australia
- Neurocrine Clinical Site - Parkville, Victoria, Australia