RECRUITING

A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

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Conditions

Major Depressive DisorderMDDNBI-1065845

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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

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Quick Facts

Study Start:2025-08-18
Study Completion:2028-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07196501

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 and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
  4. * Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
  5. * 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.
  3. * Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.

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
Melbourne, Florida, 32901
United States
Neurocrine Clinical Site
Miami Gardens, Florida, 33014
United States
Neurocrine Clinical Site
O'Fallon, Missouri, 63368
United States
Neurocrine Clinical Site
Friendswood, Texas, 77546
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 Date2025-08-18
Study Completion Date2028-07

Study Record Updates

Study Start Date2025-08-18
Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

  • Major Depressive Disorder
  • MDD
  • NBI-1065845

Additional Relevant MeSH Terms

  • Major Depressive Disorder