Recruiting
Phase 3

NBI-1065845

Sponsor:

Neurocrine Biosciences

Code:

NCT06963021

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

NCT06963021

Start date

May 30, 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

Chino, California, United States, 91710

Neurocrine Clinical Site

Recruiting

Los Angeles, California, United States, 90025

Neurocrine Clinical Site

Recruiting

Stanford, California, United States, 94305

Neurocrine Clinical Site

Recruiting

Aurora, Colorado, United States, 80045

Neurocrine Clinical Site

Recruiting

Maitland, Florida, United States, 32751

Neurocrine Clinical Site

Recruiting

Miami, Florida, United States, 33136

Neurocrine Clinical Site

Recruiting

Cedarhurst, New York, United States, 11516

Neurocrine Clinical Site

Recruiting

New York, New York, United States, 10128

Neurocrine Clinical Site

Recruiting

Charlotte, North Carolina, United States, 28211

Neurocrine Clinical Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Neurocrine Clinical Site

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Neurocrine Clinical Site

Recruiting

Verdun, Canada, H4H 1R3

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Aug 10, 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 2026-08-10.