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Long-term safety and tolerability of NBI-1065845 added to antidepressants for major depression

A Long-Term, Open-Label Study to Assess the Safety and Tolerability of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Phase 3 Interventional Neurocrine Biosciences · NCT06966401

This will test whether taking NBI-1065845 alongside regular oral antidepressants is safe and tolerable long-term for adults with major depressive disorder who haven't responded well to treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment850 (estimated)
Ages18 Years and up
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations87 sites (Huntsville, Alabama and 86 other locations)
Trial IDNCT06966401 on ClinicalTrials.gov

What this trial studies

This is a phase 3 interventional study of NBI-1065845 given as an adjunct to participants' ongoing oral antidepressants to characterize long-term safety and tolerability. Eligible participants have recurrent major depressive disorder or persistent depressive disorder and an inadequate response to current oral antidepressant treatment. Participants will continue their antidepressant regimen while receiving NBI-1065845 and will be monitored regularly for adverse events, laboratory changes, and suicidality. The protocol excludes those with another primary psychiatric disorder within the past year or those judged to be at imminent risk of self-harm.

Who should consider this trial

Good fit: Adults with recurrent major depressive disorder or persistent depressive disorder who have had an inadequate response to at least 8 weeks of oral antidepressant treatment in the current episode and who can comply with study procedures.

Not a fit: People with a primary non-MDD psychiatric disorder in the past year, those judged to be at imminent risk of suicide or harm, or those who cannot follow study procedures are unlikely to benefit from enrolling.

Why it matters

Potential benefit: If successful, this could provide an additional adjunctive medication option that is safe and tolerable for people whose depression has not responded adequately to standard oral antidepressants.

How similar studies have performed: Adjunctive pharmacologic approaches have shown benefit in prior depression trials, and early-phase data for TAK-653/NBI-1065845 suggest pharmacologic activity, but long-term adjunctive safety for this agent is not yet well established.

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 prior to screening.
* 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.

Other protocol defined inclusion and exclusion criteria apply.

Where this trial is running

Huntsville, Alabama and 86 other locations

+37 more sites — see ClinicalTrials.gov for the full list.

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-653
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.