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Long-Term Study to Assess the Safety and Tolerability of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT06966401 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 850

Last updated 2026-04-23

No results posted yet for this study

Summary

This study will evaluate the long-term safety and tolerability of NBI-1065845 as an adjunctive treatment in participants with MDD.

Conditions

Interventions

DRUG

NBI-1065845

NBI-1065845 tablets

Sponsors & Collaborators

  • Neurocrine Biosciences

    lead INDUSTRY

Principal Investigators

  • Clinical Development Lead · Neurocrine Biosciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-16
Primary Completion
2029-05-31
Completion
2030-05-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bulgaria
  • Croatia
  • Czechia
  • Estonia
  • Finland
  • Hungary
  • Latvia
  • Lithuania
  • Netherlands
  • Poland
  • Romania
  • Slovakia
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

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 NCT06966401 on ClinicalTrials.gov