RECRUITING

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

Conditions

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

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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 study will evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in participants with MDD on improving symptoms of depression.

Official Title

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Quick Facts

Study Start:2025-01-22

Study Completion:2027-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06786624

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

Inclusion Criteria

Exclusion 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 and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
* Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
* 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.
* 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

Orange, California, 92866

United States

Neurocrine Clinical Site

Maitland, Florida, 32751

United States

Neurocrine Clinical Site

Boston, Massachusetts, 02116

United States

Neurocrine Clinical Site

Watertown, Massachusetts, 02472

United States

Neurocrine Clinical Site

Avon Lake, Ohio, 44012

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 Date2025-01-22

Study Completion Date2027-07

Study Record Updates

Study Start Date2025-01-22

Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Major Depressive Disorder