Home › Trials › NCT06911112

Assessing 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 · NCT06911112

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

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment200 (estimated)
Ages18 Years and up
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations10 sites (Huntsville, Alabama and 9 other locations)
Trial IDNCT06911112 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of NBI-1065845 as an adjunctive treatment for individuals with Major Depressive Disorder (MDD) who have not responded adequately to current oral antidepressant therapies. Participants will receive either NBI-1065845 or a placebo while continuing their existing antidepressant regimen. The study aims to measure improvements in depressive symptoms using standardized assessment tools. It is a Phase 3 interventional trial, indicating a focus on confirming effectiveness and safety in a larger patient population.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with recurrent moderate to severe MDD who have not responded adequately to current oral 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 MDD who have not found relief with existing antidepressants.

How similar studies have performed: Previous studies have shown promise in using adjunctive treatments for MDD, suggesting potential for success with this approach.

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

Huntsville, Alabama and 9 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 2026-06-13 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.