RECRUITING

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

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Conditions

Major Depressive DisorderMDDDepressionNBI-1065845TAK-653

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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)

Quick Facts

Study Start:2025-04-16
Study Completion:2030-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06966401

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
  2. * Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
  3. * Participant must have been taking oral antidepressants for at least 8 weeks prior to screening.
  4. * Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.
  1. * A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
  2. * Are considered by the investigator to be at imminent risk of suicide or injury to self or others.

Contacts and Locations

Study Contact

Neurocrine Medical Information Call Center
CONTACT
1-877-641-3461
medinfo@neurocrine.com

Principal Investigator

Clinical Development Lead
STUDY_DIRECTOR
Neurocrine Biosciences

Study Locations (Sites)

Neurocrine Clinical Site
Little Rock, Arkansas, 72204
United States
Neurocrine Clinical Site
Orange, California, 92866
United States
Neurocrine Clinical Site
Pico Rivera, California, 90660
United States
Neurocrine Clinical Site
Upland, California, 91786
United States
Neurocrine Clinical Site
Hollywood, Florida, 33024
United States
Neurocrine Clinical Site
Maitland, Florida, 32751-5669
United States
Neurocrine Clinical Site
Tampa, Florida, 33607
United States
Neurocrine Clinical Site
Atlanta, Georgia, 30318
United States
Neurocrine Clinical Site
Boston, Massachusetts, 02116
United States
Neurocrine Clinical Site
Watertown, Massachusetts, 02472
United States
Neurocrine Clinical Site
Saint Charles, Missouri, 63304
United States
Neurocrine Clinical Site
Bronx, New York, 10461
United States
Neurocrine Clinical Site
Mount Kisco, New York, 10549
United States
Neurocrine Clinical Site
Avon Lake, Ohio, 44012
United States
Neurocrine Clinical Site
Dallas, Texas, 75251
United States
Neurocrine Clinical Site
Richmond, Texas, 77407
United States
Neurocrine Clinical Site
The Woodlands, Texas, 77381
United States
Neurocrine Clinical Site
Everett, Washington, 98201
United States

Collaborators and Investigators

Sponsor: Neurocrine Biosciences

  • Clinical Development Lead, STUDY_DIRECTOR, Neurocrine Biosciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-16
Study Completion Date2030-05

Study Record Updates

Study Start Date2025-04-16
Study Completion Date2030-05

Terms related to this study

Keywords Provided by Researchers

  • MDD
  • Depression
  • Major Depressive Disorder
  • NBI-1065845
  • TAK-653

Additional Relevant MeSH Terms

  • Major Depressive Disorder