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NBI-1065845 as an adjunctive maintenance treatment for major depressive disorder

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Phase 3 Interventional Neurocrine Biosciences · NCT07196501

This Phase 3 test will see if adding NBI-1065845 to a person’s current oral antidepressant helps delay relapse in people with recurrent major depressive disorder who have not responded adequately to their current medication.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment550 (estimated)
Ages18 Years and up
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations45 sites (Oceanside, California and 44 other locations)
Trial IDNCT07196501 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with recurrent MDD or persistent depressive disorder who have had an inadequate response to their current oral antidepressant, have been stable on that antidepressant for at least 8 weeks, and have a HAM-D17 score of 22 or higher at baseline.

Not a fit: People with a primary psychiatric disorder other than MDD in the past year, those judged to be at imminent suicide risk, or those already stably responding to their current antidepressant are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the treatment could reduce relapse rates and extend the duration of symptom control for people with recurrent MDD on oral antidepressants.

How similar studies have performed: Other adjunctive strategies have shown benefit in reducing relapse risk in MDD, but NBI-1065845 is a newer agent and this Phase 3 trial aims to provide confirmatory evidence of its maintenance effect.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Oceanside, California and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Major Depressive DisorderMDDNBI-1065845
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.