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A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder

NCT06267846

CompletedPhase 2

Sponsor: Neurocrine Biosciences

Conditions: Major Depressive Disorder

Interventions: NBI-1070770, Placebo

Countries: United States

To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (13)
  • Little Rock, Arkansas, United States
  • Rogers, Arkansas, United States
  • Lemon Grove, California, United States
  • Long Beach, California, United States
  • Hollywood, Florida, United States
  • Maitland, Florida, United States
  • Decatur, Georgia, United States
  • Savannah, Georgia, United States
  • Gaithersburg, Maryland, United States
  • Dayton, Ohio, United States
  • North Canton, Ohio, United States
  • Houston, Texas, United States
  • Richardson, Texas, United States