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RECRUITINGPhase 3INTERVENTIONAL

Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Who May Be Eligible (Plain English)

Key Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

NBI-1065845

NBI-1065845 tablets

Locations (18)

Neurocrine Clinical Site
Little Rock, Arkansas, United States
Neurocrine Clinical Site
Orange, California, United States
Neurocrine Clinical Site
Pico Rivera, California, United States
Neurocrine Clinical Site
Upland, California, United States
Neurocrine Clinical Site
Hollywood, Florida, United States
Neurocrine Clinical Site
Maitland, Florida, United States
Neurocrine Clinical Site
Tampa, Florida, United States
Neurocrine Clinical Site
Atlanta, Georgia, United States
Neurocrine Clinical Site
Boston, Massachusetts, United States
Neurocrine Clinical Site
Watertown, Massachusetts, United States
Neurocrine Clinical Site
Saint Charles, Missouri, United States
Neurocrine Clinical Site
Mount Kisco, New York, United States
Neurocrine Clinical Site
The Bronx, New York, United States
Neurocrine Clinical Site
Avon Lake, Ohio, United States
Neurocrine Clinical Site
Dallas, Texas, United States
Neurocrine Clinical Site
Richmond, Texas, United States
Neurocrine Clinical Site
The Woodlands, Texas, United States
Neurocrine Clinical Site
Everett, Washington, United States