A Study to Evaluate the Maintenance Effect of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

ClinicalTrials.gov ID: NCT07196501

Public ClinicalTrials.gov record NCT07196501. 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 Oct 17, 2026, 6:16 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI-1065845 as an Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)

Brief summary

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

The primary objective of this study is to evaluate the efficacy of NBI-1065845 compared with placebo as an adjunctive treatment in delaying relapse of depressive symptoms (maintenance of effect) in participants with MDD.

Study identification

NCT ID: NCT07196501
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Neurocrine Biosciences; Industry
Enrollment: 550 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: Aug 18, 2025 (Actual)
Primary completion: Jul 2028 (Estimated)
Completion: Jul 2028 (Estimated)
Last update posted: Jul 24, 2026

2025 – 2028

United States locations

U.S. sites: 24
U.S. states: 14
U.S. cities: 24

Facility	City	State	ZIP	Site status
Neurocrine Clinical Site	Oceanside	California	92056	Recruiting
Neurocrine Clinical Site	Orange	California	92868	Recruiting
Neurocrine Clinical Site	San Jose	California	95124	Recruiting
Neurocrine Clinical Site	New Haven	Connecticut	06520	Recruiting
Neurocrine Clinical Site	Miami Gardens	Florida	33014	Recruiting
Neurocrine Clinical Site	Orlando	Florida	32803	Recruiting
Neurocrine Clinical Site	Palm Bay	Florida	32905	Recruiting
Neurocrine Clinical Site	Tampa	Florida	33629	Recruiting
Neurocrine Clinical Site	Iowa City	Iowa	52242	Recruiting
Neurocrine Clinical Site	Marrero	Louisiana	70072	Recruiting
Neurocrine Clinical Site	O'Fallon	Missouri	63368	Recruiting
Neurocrine Clinical Site	Albuquerque	New Mexico	87109	Recruiting
Neurocrine Clinical Site	Glen Oaks	New York	11004	Recruiting
Neurocrine Clinical Site	Charlotte	North Carolina	28211	Recruiting
Neurocrine Clinical Site	Edmond	Oklahoma	73013	Recruiting
Neurocrine Clinical Site	Oklahoma City	Oklahoma	73112	Recruiting
Neurocrine Clinical Site	Philadelphia	Pennsylvania	19104	Recruiting
Neurocrine Clinical Site	Austin	Texas	78712	Active, not recruiting
Neurocrine Clinical Site	Bellaire	Texas	77401	Recruiting
Neurocrine Clinical Site	Friendswood	Texas	77546	Terminated
Neurocrine Clinical Site	Stafford	Texas	77477	Recruiting
Neurocrine Clinical Site	Wichita Falls	Texas	76309	Recruiting
Neurocrine Clinical Site	Draper	Utah	84020	Recruiting
Neurocrine Clinical Site	Roanoke	Virginia	24018	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 36 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07196501, 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 Jul 24, 2026 · Synced Oct 17, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT07196501 live on ClinicalTrials.gov.

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