Long-term safety and tolerability of NBI-1065845 added to antidepressants for major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3 interventional study of NBI-1065845 given as an adjunct to participants' ongoing oral antidepressants to characterize long-term safety and tolerability. Eligible participants have recurrent major depressive disorder or persistent depressive disorder and an inadequate response to current oral antidepressant treatment. Participants will continue their antidepressant regimen while receiving NBI-1065845 and will be monitored regularly for adverse events, laboratory changes, and suicidality. The protocol excludes those with another primary psychiatric disorder within the past year or those judged to be at imminent risk of self-harm.

Why it matters

Who can join: the full rules

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.

Where it's running

• Neurocrine Clinical Site
  Huntsville, Alabama, United States Recruiting
• Neurocrine Clinical Site
  Bryant, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Little Rock, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Chino, California, United States Recruiting
• Neurocrine Clinical Site
  Glendale, California, United States Recruiting
• Neurocrine Clinical Site
  Irvine, California, United States Recruiting

+70 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Neurocrine Medical Information Call Center
• Email: medinfo@neurocrine.com
• Phone: 1-877-641-3461

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.