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

ClinicalTrials.gov ID: NCT06911112

Public ClinicalTrials.gov record NCT06911112. 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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ClinicalTrials.gov public records Last synced Sep 1, 2026, 6:18 PM EDT

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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: NCT06911112
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: Mar 30, 2025
Primary completion: Jun 30, 2027
Completion: Jun 30, 2027
Last update posted: Aug 10, 2026

2025 – 2027

United States locations

U.S. sites: 17
U.S. states: 11
U.S. cities: 17

Facility	City	State	ZIP	Site status
Neurocrine Clinical Site	Huntsville	Alabama	35801	Recruiting
Neurocrine Clinical Site	Bryant	Arkansas	72022	Recruiting
Neurocrine Clinical Site	Glendale	California	91206	Recruiting
Neurocrine Clinical Site	Irvine	California	92614	Withdrawn
Neurocrine Clinical Site	Redlands	California	92373	Recruiting
Neurocrine Clinical Site	San Francisco	California	94107	Recruiting
Neurocrine Clinical Site	Hollywood	Florida	33024	Recruiting
Neurocrine Clinical Site	Miami	Florida	33174	Active, not recruiting
Neurocrine Clinical Site	Tampa	Florida	33634	Recruiting
Neurocrine Clinical Site	Atlanta	Georgia	30318	Recruiting
Neurocrine Clinical Site	Boston	Massachusetts	02131	Withdrawn
Neurocrine Clinical Site	Saint Charles	Missouri	63304	Active, not recruiting
Neurocrine Clinical Site	New York	New York	10029	Recruiting
Neurocrine Clinical Site	The Bronx	New York	10461	Active, not recruiting
Neurocrine Clinical Site	Mason	Ohio	45040	Recruiting
Neurocrine Clinical Site	DeSoto	Texas	75115	Recruiting
Neurocrine Clinical Site	Charlottesville	Virginia	22903	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 22 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT06911112, 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 10, 2026 · Synced Sep 1, 2026

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The complete protocol, eligibility criteria, and contact information for NCT06911112 live on ClinicalTrials.gov.

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