Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)

Phase 2

Completed

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

• Registration Number: NCT05203341
• Lead Sponsor: Neurocrine Biosciences

Brief Summary

The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-18
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-24
• Study Start: 2022-02-21
• Primary Completion: 2024-01-10
• Study Completion: 2024-02-21
• Disposition First Posted: 2024-03-25
• Status Verified: 2025-01
• Disposition First Submitted: 2025-01-09
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Participants must meet all of these criteria for inclusion in the study:

1. The participant has completed written informed consent.
2. At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
3. The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
4. Participant must have had inadequate response to antidepressant treatment.
5. Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
6. Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. Subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression.
7. Participants must be willing and able to comply with all study procedures.

Key

Exclusion Criteria

Participants will be excluded from the study if they meet any of the following criteria:

1. Participant is pregnant or breastfeeding or plans to become pregnant during the study.
2. Participant has an unstable medical condition or unstable chronic disease.
3. Participant has a history of neurological abnormalities.
4. Participant has a current or prior psychiatric disorder that was the primary focus of treatment other than MDD.
5. The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
6. The participant has an alcohol or substance use disorder.
7. In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo orally once a day.
NBI-1065845 Low Dose	NBI-1065845	Participants will receive low-dose NBI-1065845 orally once a day.
NBI-1065845 High Dose	NBI-1065845	Participants will receive high-dose NBI-1065845 orally once a day.

Primary Outcome Measures

Name	Time	Method
Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28	Baseline, Day 28

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56	Baseline, Days 7, 14, and 56
Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56	Baseline, Days 28 and 56
Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56	Baseline, Days 28 and 56
Remission, defined as MADRS ≤10, at Days 28 and 56	Days 28 and 56
Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56	Baseline, Days 28 and 56

Trial Locations

Locations (1)

Neurocrine Clinical Site; 🇸🇪 Stockholm, Sweden