Recruiting
Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
ClinicalTrials.gov IDNCT06966401
PhasePHASE3
Enrollment850
SponsorNeurocrine Biosciences
Age18 Years
SexALL
Conditions studied
Major Depressive Disorder
About this study
This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.
Interventions
- Drug: NBI-1065845 — NBI-1065845 tablets
Primary outcomes
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) (Baseline through Week 52)
Eligibility information
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 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.
Other protocol defined inclusion and exclusion criteria apply.
Study locations
- Neurocrine Clinical Site, Huntsville, Alabama 35801 United States
- Neurocrine Clinical Site, Bryant, Arkansas 72022 United States
- Neurocrine Clinical Site, Little Rock, Arkansas 72204 United States
- Neurocrine Clinical Site, Glendale, California 91206 United States
- Neurocrine Clinical Site, Los Angeles, California 90025 United States
- Neurocrine Clinical Site, Oceanside, California 92056 United States
- Neurocrine Clinical Site, Orange, California 92866 United States
- Neurocrine Clinical Site, Pico Rivera, California 90660 United States
- Neurocrine Clinical Site, San Diego, California 92103-8229 United States
- Neurocrine Clinical Site, San Francisco, California 94107 United States
Showing 10 of 106 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.