Recruiting
Phase 3

NBI-1065845

Sponsor:

Neurocrine Biosciences

Code:

NCT06786624

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

NCT06786624

Start date

Jan 22, 2025

Status verified date

Oct, 2025

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

Little Rock, Arkansas, United States, 72204

Neurocrine Clinical Site

Recruiting

Orange, California, United States, 92866

Neurocrine Clinical Site

Recruiting

Pico Rivera, California, United States, 90660

Neurocrine Clinical Site

Recruiting

San Diego, California, United States, 92103

Neurocrine Clinical Site

Recruiting

Upland, California, United States, 91786

Neurocrine Clinical Site

Recruiting

Hollywood, Florida, United States, 33024

Neurocrine Clinical Site

Recruiting

Maitland, Florida, United States, 32751

Neurocrine Clinical Site

Recruiting

Boston, Massachusetts, United States, 02116

Neurocrine Clinical Site

Recruiting

Mount Kisco, New York, United States, 10549

Neurocrine Clinical Site

Recruiting

Avon Lake, Ohio, United States, 44012

Neurocrine Clinical Site

Recruiting

Dallas, Texas, United States, 75251

Neurocrine Clinical Site

Recruiting

Houston, Texas, United States, 77030

Neurocrine Clinical Site

Recruiting

Everett, Washington, United States, 98201

More Information

Sponsor

Neurocrine Biosciences

Last update posted

Oct 29, 2025

Last verified

Oct, 2025

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 2025-10-29.