Evaluating 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 assesses the efficacy and safety of NBI-1065845 as an additional treatment for individuals with major depressive disorder (MDD) who have not adequately responded to standard oral antidepressants. Participants will receive either NBI-1065845 or a placebo while continuing their current antidepressant regimen. The study aims to measure improvements in depressive symptoms using standardized scales. It is a Phase 3 interventional trial, indicating a focus on confirming the treatment's effectiveness and safety.

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
  Little Rock, Arkansas, United States Recruiting
• Neurocrine Clinical Site
  Orange, California, United States Recruiting
• Neurocrine Clinical Site
  Pico Rivera, California, United States Recruiting
• Neurocrine Clinical Site
  San Diego, California, United States Recruiting
• Neurocrine Clinical Site
  Upland, 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.