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

NCT07196501 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2026-03-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

NBI-1065845

Oral tablet

DRUG

Placebo

Oral tablet

Sponsors & Collaborators

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Clinical Development Lead · Neurocrine Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-18
Primary Completion
2028-07-31
Completion
2028-07-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Bulgaria
  • Canada
  • Estonia
  • Italy
  • Poland
  • Serbia
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07196501 on ClinicalTrials.gov