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Evaluating NBI-1070770 for treating major depressive disorder in adults

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1070770 in Adults With Major Depressive Disorder

Phase 2 Interventional Neurocrine Biosciences · NCT06267846

This study is testing a new medication called NBI-1070770 to see if it can help adults with major depressive disorder feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment72 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorNeurocrine Biosciences Industry-sponsored
Locations13 sites (Little Rock, Arkansas and 12 other locations)
Trial IDNCT06267846 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy, safety, and tolerability of NBI-1070770 in adults diagnosed with major depressive disorder (MDD) compared to a placebo. Participants will include those currently receiving antidepressant treatment for at least eight weeks and will be monitored for improvements in their depressive symptoms. The study will involve regular assessments to determine the drug's impact on mood and overall mental health.

Who should consider this trial

Good fit: Ideal candidates are adults with a primary diagnosis of recurrent or persistent major depressive disorder who are currently on stable antidepressant medication.

Not a fit: Patients who are pregnant, breastfeeding, or have unstable medical conditions or other primary psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients suffering from major depressive disorder.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in developing new antidepressant treatments.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

* Primary diagnosis of recurrent MDD or persistent MDD.
* Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening and must be willing and able to continue with current antidepressant medication(s).
* Participants must be willing and able to comply with all study procedures and restrictions.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

* Participant is pregnant or breastfeeding or plan to become pregnant during the study.
* Participant has an unstable medical condition or unstable chronic disease.
* Participant has a history of neurological abnormalities.
* Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD.
* Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy.
* Participant has an alcohol or substance use disorder.

Note: Other inclusion/exclusion criteria may apply

Where this trial is running

Little Rock, Arkansas and 12 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-1070770NeurocrineAntidepressantDepressionMontgomery-Åsberg Depression Rating ScaleMADRS
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.