NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

ClinicalTrials.gov ID: NCT06963021

Public ClinicalTrials.gov record NCT06963021. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT06963021
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Neurocrine Biosciences; Industry
Enrollment: 200 participants

Conditions and interventions

Conditions

Major Depressive Disorder

Interventions

NBI-1065845 Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 29, 2025
Primary completion: Jun 30, 2027
Completion: Jun 30, 2027
Last update posted: Aug 9, 2026

2025 – 2027

United States locations

U.S. sites: 15
U.S. states: 8
U.S. cities: 14

Facility	City	State	ZIP	Site status
Neurocrine Clinical Site	Chino	California	91710	Recruiting
Neurocrine Clinical Site	Los Angeles	California	90025	Recruiting
Neurocrine Clinical Site	Stanford	California	94305	Recruiting
Neurocrine Clinical Site	Aurora	Colorado	80045	Recruiting
Neurocrine Clinical Site	Cromwell	Connecticut	06416	Active, not recruiting
Neurocrine Clinical Site	Farmington	Connecticut	06030	Active, not recruiting
Neurocrine Clinical Site	Maitland	Florida	32751	Recruiting
Neurocrine Clinical Site	Miami	Florida	33136	Recruiting
Neurocrine Clinical Site	Tampa	Florida	33613	Withdrawn
Neurocrine Clinical Site	Gaithersburg	Maryland	20877	Active, not recruiting
Neurocrine Clinical Site	Cedarhurst	New York	11516	Recruiting
Neurocrine Clinical Site	New York	New York	10029	Active, not recruiting
Neurocrine Clinical Site	New York	New York	10128	Recruiting
Neurocrine Clinical Site	Charlotte	North Carolina	28211	Recruiting
Neurocrine Clinical Site	Philadelphia	Pennsylvania	19104	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 20 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06963021, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Aug 9, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06963021 live on ClinicalTrials.gov.

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