Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Recruiting · NCT06966401 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment 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 prior to screening.
- 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.
- ther protocol defined inclusion and exclusion criteria apply.
Where it is running
60 locations listed across 15 US states.
- Neurocrine Clinical Site - Huntsville, Alabama, United States
- Neurocrine Clinical Site - Bryant, Arkansas, United States
- Neurocrine Clinical Site - Little Rock, Arkansas, United States
- Neurocrine Clinical Site - Glendale, California, United States
- Neurocrine Clinical Site - Los Angeles, California, United States
- Neurocrine Clinical Site - Oceanside, 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 - San Francisco, California, United States
- Neurocrine Clinical Site - San Jose, California, United States
- Neurocrine Clinical Site - Upland, California, United States
- Neurocrine Clinical Site - Cromwell, Connecticut, United States
- Neurocrine Clinical Site - Farmington, Connecticut, United States
- Neurocrine Clinical Site - Hollywood, Florida, United States
- Neurocrine Clinical Site - Maitland, Florida, United States
- Neurocrine Clinical Site - Maitland, Florida, United States
- Neurocrine Clinical Site - Miami, Florida, 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 - Tampa, Florida, United States
- Neurocrine Clinical Site - Atlanta, Georgia, United States
- Neurocrine Clinical Site - Gaithersburg, Maryland, United States
- Neurocrine Clinical Site - Boston, Massachusetts, United States
- Neurocrine Clinical Site - Watertown, Massachusetts, United States
- Neurocrine Clinical Site - O'Fallon, Missouri, United States
- Neurocrine Clinical Site - Saint Charles, Missouri, United States
- Neurocrine Clinical Site - Cedarhurst, New York, United States
- Neurocrine Clinical Site - Mount Kisco, New York, United States
- Neurocrine Clinical Site - New York, New York, United States
- Neurocrine Clinical Site - New York, New York, United States
- Neurocrine Clinical Site - The Bronx, New York, United States
- Neurocrine Clinical Site - Avon Lake, Ohio, 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 - Bellaire, Texas, United States
- Neurocrine Clinical Site - Dallas, Texas, United States
- Neurocrine Clinical Site - DeSoto, Texas, United States
- Neurocrine Clinical Site - Houston, Texas, United States
- Neurocrine Clinical Site - Richmond, Texas, United States
- Neurocrine Clinical Site - Stafford, Texas, United States
- Neurocrine Clinical Site - The Woodlands, Texas, United States
- Neurocrine Clinical Site - Everett, Washington, United States
- Neurocrine Clinical Site - Alken, Belgium
- Neurocrine Clinical Site - Amsterdam, Netherlands
- Neurocrine Clinical Site - Bełchatów, Poland
- Neurocrine Clinical Site - Bialystok, Poland
- Neurocrine Clinical Site - Bialystok, Poland
- Neurocrine Clinical Site - Bialystok, Poland
- Neurocrine Clinical Site - Bojnice, Slovakia
- Neurocrine Clinical Site - Bratislava, Slovakia
- Neurocrine Clinical Site - Budapest, Hungary
- Neurocrine Clinical Site - Bydgoszcz, Poland
- Neurocrine Clinical Site - Craiova, Romania
- Neurocrine Clinical Site - Gdansk, Poland
- Neurocrine Clinical Site - Gdansk, Poland
- Neurocrine Clinical Site - Gothenburg, Sweden
Showing 60 of 106 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →