A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder

Phase 2

Recruiting

• Conditions: Major Depressive Disorder
• Interventions: Drug: NBI-1070770; Drug: Placebo

• Registration Number: NCT06267846
• Lead Sponsor: Neurocrine Biosciences

Brief Summary

To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-12
• Study First Submitted QC: 2024-02-12
• Study First Posted: 2024-02-20
• Study Start: 2024-03-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-28
• Primary Completion: 2025-09
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Participants must meet all of the following inclusion criteria:

• Primary diagnosis of recurrent MDD or persistent MDD.
• Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening and must be willing and able to continue with current antidepressant medication(s).
• Participants must be willing and able to comply with all study procedures and restrictions.

Key

Exclusion Criteria

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

• Participant is pregnant or breastfeeding or plan to become pregnant during the study.
• Participant has an unstable medical condition or unstable chronic disease.
• Participant has a history of neurological abnormalities.
• Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD.
• Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy.
• Participant has an alcohol or substance use disorder.

Note: Other inclusion/exclusion criteria may apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NBI-1070770: Medium Dose	NBI-1070770	Participants will receive medium-dose NBI-1070770.
NBI-1070770: Low Dose	NBI-1070770	Participants will receive low-dose NBI-1070770.
Placebo	Placebo	Participants will receive matching placebo.
NBI-1070770: High Dose	NBI-1070770	Participants will receive high-dose NBI-1070770.

Primary Outcome Measures

Name	Time	Method
Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5	Baseline, Day 5

Secondary Outcome Measures

Name	Time	Method
Change in Total MADRS Score from Baseline at Postbaseline Timepoints	Baseline, up to Day 49

Trial Locations

Locations (1)

Neurocrine Clinical Site; 🇺🇸 Richardson, Texas, United States