RECRUITING

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

Description

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

Conditions

Major Depressive Disorder
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Related Conditions:

Major Depressive Disorder

Study Overview

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Study Details

Study overview

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

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

Condition
Major Depressive Disorder
Intervention / Treatment

-

Contacts and Locations

Little Rock

Neurocrine Clinical Site, Little Rock, Arkansas, United States, 72204

Orange

Neurocrine Clinical Site, Orange, California, United States, 92866

Pico Rivera

Neurocrine Clinical Site, Pico Rivera, California, United States, 90660

Upland

Neurocrine Clinical Site, Upland, California, United States, 91786

Hollywood

Neurocrine Clinical Site, Hollywood, Florida, United States, 33024

Maitland

Neurocrine Clinical Site, Maitland, Florida, United States, 32751-5669

Tampa

Neurocrine Clinical Site, Tampa, Florida, United States, 33607

Atlanta

Neurocrine Clinical Site, Atlanta, Georgia, United States, 30318

Boston

Neurocrine Clinical Site, Boston, Massachusetts, United States, 02116

Watertown

Neurocrine Clinical Site, Watertown, Massachusetts, United States, 02472

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neurocrine Biosciences,

Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

2030-05