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Evaluating NBI-1065845 for treating major depressive disorder

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Phase 3 Interventional Neurocrine Biosciences · NCT06786624

This study is testing a new treatment called NBI-1065845 to see if it can help people with major depressive disorder who haven't felt better with their current antidepressants.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations18 sites (Little Rock, Arkansas and 17 other locations)
Trial IDNCT06786624 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with recurrent major depressive disorder or persistent depressive disorder who have not adequately responded to previous antidepressant treatments.

Not a fit: Patients with other primary psychiatric disorders or those at imminent risk of self-harm may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for patients with major depressive disorder who have not responded well to existing therapies.

How similar studies have performed: Previous studies have shown promise in similar approaches for treating major depressive disorder, but the specific efficacy of NBI-1065845 is being evaluated for the first time in this context.

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.

Where this trial is running

Little Rock, Arkansas and 17 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 DisorderMDDDepressionNBI-1065845TAK-653MADRS
Last reviewed 2026-06-09 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.