Recruiting
Phase 3

NBI-1065845

Sponsor:

Neurocrine Biosciences

Code:

NCT06911112

Conditions

Major Depressive Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NBI-1065845

Placebo

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder

Study ID

NCT06911112

Start date

Mar 31, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • Participant has a primary diagnosis of recurrent MDD (moderate or severe) or persistent depressive disorder.
  • Participant has had an inadequate response to oral antidepressant treatments in the current episode of depression.
  • Participant must have been taking oral antidepressants for at least 8 weeks and is willing to continue the same oral antidepressants at the same dose and frequency of administration throughout participation in the study.
  • Total Hamilton Depression Rating Scale-17 Item (HAM-D17) score ≥22 at screening and at study baseline (Day 1).
  • Willing and able to comply with all study procedures and restrictions in the opinion of the investigator.

Key Exclusion Criteria:

  • A current or prior psychiatric disorder diagnosis in the last 1 year that was the primary focus of treatment other than MDD.
  • Are considered by the investigator to be at imminent risk of suicide or injury to self or others.
  • Participants depressive symptoms have previously demonstrated nonresponse to electroconvulsive therapy (ECT) in the current major depressive episode.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NBI-1065845

NBI-1065845 administered orally once a day.

placebo comparator: Placebo

Placebo identical in appearance to NBI-1065845 will be administered orally once a day.

Interventions

NBI-1065845

NBI-1065845 tablets

Placebo

Matching placebo tablets

Primary outcome measure

  • Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56 [ Time Frame: Baseline, Day 56 ]

Central Contacts and Locations

Central contacts

Neurocrine Medical Information Call Center

1-877-641-3461medinfo@neurocrine.com

Locations

Neurocrine Clinical Site

Recruiting

Huntsville, Alabama, United States, 35801

Neurocrine Clinical Site

Recruiting

Bryant, Arkansas, United States, 72022

Neurocrine Clinical Site

Recruiting

Glendale, California, United States, 91206

Neurocrine Clinical Site

Recruiting

Redlands, California, United States, 92373

Neurocrine Clinical Site

Recruiting

San Francisco, California, United States, 94107

Neurocrine Clinical Site

Recruiting

Hollywood, Florida, United States, 33024

Neurocrine Clinical Site

Recruiting

Tampa, Florida, United States, 33634

Neurocrine Clinical Site

Recruiting

Atlanta, Georgia, United States, 30318

Neurocrine Clinical Site

Recruiting

New York, New York, United States, 10029

Neurocrine Clinical Site

Recruiting

Mason, Ohio, United States, 45040

Neurocrine Clinical Site

Recruiting

DeSoto, Texas, United States, 75115

Neurocrine Clinical Site

Recruiting

Charlottesville, Virginia, United States, 22903

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Aug 11, 2026

Last verified

Aug, 2026

Keywords

  • MDD
  • Depression
  • Major Depressive Disorder
  • NBI-1065845
  • TAK-653
  • MADRS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neurocrine Biosciences on 2026-08-11.