NBI-1065845-MDD3025: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified October 2025 by Neurocrine Biosciences
Sponsor
Neurocrine Biosciences
Information Provided by (Responsible Party)
Neurocrine Biosciences
Clinicaltrials.gov Identifier
NCT06911112
Other Study ID Numbers:
NBI-1065845-MDD3025
First Submitted
March 27, 2025
First Posted
April 3, 2025
Last Update Posted
November 30, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on November 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Major Depressive Disorder
Drug: NBI-1065845Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment200 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA 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)
Study Start DateMarch 30, 2025
Actual Primary Completion Date1yr 2w from now
Actual Study Completion Date1yr 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
NBI-1065845
NBI-1065845 administered orally once a day.
Drug: NBI-1065845
NBI-1065845 tablets
Placebo
Placebo identical in appearance to NBI-1065845 will be administered orally once a day.
Drug: Placebo
Matching placebo tablets

Outcome Measures

Primary Outcome Measures
  1. Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
Secondary Outcome Measures
  1. Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
  2. Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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 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. 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.
Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.

Contacts and Locations

Sponsors and CollaboratorsNeurocrine Biosciences
Locations
Neurocrine Clinical Site | Huntsville Alabama, United States, 35801Neurocrine Clinical Site | Glendale California, United States, 91206Neurocrine Clinical Site | Irvine California, United States, 92614Neurocrine Clinical Site | Miami Florida, United States, 33174Neurocrine Clinical Site | Tampa Florida, United States, 33607Neurocrine Clinical Site | Atlanta Georgia, United States, 30318Neurocrine Clinical Site | Boston Massachusetts, United States, 02131Neurocrine Clinical Site | Saint Charles Missouri, United States, 63304Neurocrine Clinical Site | The Bronx New York, United States, 10461Neurocrine Clinical Site | Mason Ohio, United States, 45040
Investigators
Study Director: Clinical Development Lead, Neurocrine Biosciences