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

Phase 3

Recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: NBI-1065845

• Registration Number: NCT06786624
• Lead Sponsor: Neurocrine Biosciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-15
• Study Start: 2025-01-22
• Study First Posted: 2025-01-22
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-06
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo identical in appearance to NBI-1065845 will be administered orally once a day.
NBI-1065845	NBI-1065845	NBI-1065845 administered orally once a day.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56	Baseline, Day 56

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56	Baseline, Day 56
Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56	Baseline, Day 56

Trial Locations

Locations (1)

Neurocrine Clinical Site; 🇺🇸 Everett, Washington, United States