Assessing NBI-1065845 for treating major depressive disorder

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 study evaluates the efficacy and safety of NBI-1065845 as an adjunctive treatment for individuals with Major Depressive Disorder (MDD) who have not responded adequately to current oral antidepressant therapies. Participants will receive either NBI-1065845 or a placebo while continuing their existing antidepressant regimen. The study aims to measure improvements in depressive symptoms using standardized assessment tools. It is a Phase 3 interventional trial, indicating a focus on confirming effectiveness and safety in a larger patient population.

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 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's running

• Neurocrine Clinical Site
  Huntsville, Alabama, United States Recruiting
• Neurocrine Clinical Site
  Bryant, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Glendale, California, United States Recruiting
• Neurocrine Clinical Site
  Redlands, California, United States Recruiting
• Neurocrine Clinical Site
  San Francisco, California, United States Recruiting
• Neurocrine Clinical Site
  Hollywood, Florida, United States Recruiting

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.