NBI-1065845 added to a current antidepressant for 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 is a Phase 3 interventional trial comparing NBI-1065845 with placebo as an add-on to participants' ongoing oral antidepressant medication. Eligible participants have recurrent moderate or severe MDD or persistent depressive disorder and an inadequate response to oral antidepressants, with a HAM-D17 score of 22 or higher at screening and baseline. Participants must have been on a stable oral antidepressant regimen for at least 8 weeks and continue that regimen unchanged during the trial while receiving either NBI-1065845 or placebo. Symptom change will be measured using standard depression rating scales to determine whether the adjunctive therapy provides additional benefit.

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
  Chino, California, United States Recruiting
• Neurocrine Clinical Site
  Los Angeles, California, United States Recruiting
• Neurocrine Clinical Site
  Stanford, California, United States Recruiting
• Neurocrine Clinical Site
  Aurora, Colorado, United States Recruiting
• Neurocrine Clinical Site
  Maitland, Florida, United States Recruiting
• Neurocrine Clinical Site
  Miami, 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.