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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
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