NBI-1065845 as an adjunctive maintenance treatment 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 Phase 3 interventional trial compares adjunctive NBI-1065845 with placebo to determine whether it can maintain antidepressant effect and delay relapse of depressive symptoms in participants with recurrent MDD. Eligible participants must have had an inadequate response in the current episode, have been on the same oral antidepressant for at least 8 weeks, and have HAM-D17 scores ≥22 at screening and baseline. Participants will continue their stable oral antidepressant and receive either NBI-1065845 or matching placebo while relapse rates are monitored over the maintenance period. Key exclusions include a primary non-MDD psychiatric disorder treated in the past year and participants judged to be at imminent risk of suicide or harm, and the trial is conducted at Neurocrine clinical sites in California and Connecticut.

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.

Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Where it's running

• Neurocrine Clinical Site
  Oceanside, California, United States Recruiting
• Neurocrine Clinical Site
  Orange, California, United States Recruiting
• Neurocrine Clinical Site
  San Jose, California, United States Recruiting
• Neurocrine Clinical Site
  New Haven, Connecticut, United States Recruiting
• Neurocrine Clinical Site
  Miami Gardens, Florida, United States Recruiting
• Neurocrine Clinical Site
  Orlando, Florida, United States Recruiting

+11 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.