NBI-1065845-MDD3026: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)

NCT06963021 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: NBI-1065845-MDD30262024-519421-37-00
• Study Type: interventional
• Target: 200
• Locations: 7 countries
• Sites: 30

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56

  Baseline, Day 56

Secondary Outcomes (2)

• Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56

  Baseline, Day 56

• Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56

  Baseline, Day 56

Study Arms (2)

NBI-1065845

EXPERIMENTAL

NBI-1065845 administered orally once a day.

Drug: NBI-1065845

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

NBI-1065845 DRUG

NBI-1065845 tablets

Also known as: TAK-653

NBI-1065845

Placebo DRUG

Matching placebo tablets

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Neurocrine Biosciences: lead

Study Sites (30)

Neurocrine Clinical Site

Chino, California, 91710, United States

RECRUITING

Neurocrine Clinical Site

Los Angeles, California, 90025, United States

RECRUITING

Neurocrine Clinical Site

Stanford, California, 94305, United States

RECRUITING

Neurocrine Clinical Site

Aurora, Colorado, 80045, United States

RECRUITING

Neurocrine Clinical Site

Cromwell, Connecticut, 06416, United States

ACTIVE NOT RECRUITING

Neurocrine Clinical Site

Farmington, Connecticut, 06030, United States

ACTIVE NOT RECRUITING

Neurocrine Clinical Site

Maitland, Florida, 32751, United States

RECRUITING

Neurocrine Clinical Site

Miami, Florida, 33136, United States

RECRUITING

Neurocrine Clinical Site

Tampa, Florida, 33613, United States

WITHDRAWN

Neurocrine Clinical Site

Gaithersburg, Maryland, 20877, United States

ACTIVE NOT RECRUITING

Neurocrine Clinical Site

Cedarhurst, New York, 11516, United States

RECRUITING

Neurocrine Clinical Site

New York, New York, 10029, United States

ACTIVE NOT RECRUITING

Neurocrine Clinical Site

New York, New York, 10128, United States

RECRUITING

Neurocrine Clinical Site

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Neurocrine Clinical Site

Alken, 3570, Belgium

ACTIVE NOT RECRUITING

Neurocrine Clinical Site

Bruges, 8310, Belgium

RECRUITING

Neurocrine Clinical Site

Mechelen, 2800, Belgium

RECRUITING

Neurocrine Clinical Site

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Neurocrine Clinical Site

Kuopio, 70110, Finland

RECRUITING

Neurocrine Clinical Site

Oulu, 90100, Finland

RECRUITING

Neurocrine Clinical Site

Tampere, 33210, Finland

RECRUITING

Neurocrine Clinical Site

Budapest, 1036, Hungary

RECRUITING

Neurocrine Clinical Site

Budapest, 1083, Hungary

RECRUITING

Neurocrine Clinical Site

Gyöngyös, 3200, Hungary

RECRUITING

Neurocrine Clinical Site

Jelgava, LV-3008, Latvia

RECRUITING

Neurocrine Clinical Site

Liepāja, LV-3401, Latvia

RECRUITING

Neurocrine Clinical Site

Sigulda, LV-2150, Latvia

RECRUITING

Neurocrine Clinical Site

Manchester, M8 5RB, United Kingdom

RECRUITING

Neurocrine Clinical Site

Sheffield, S5 7JT, United Kingdom

RECRUITING

Neurocrine Clinical Site

Southampton, SO30 3JB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Clinical Development Lead

  Neurocrine Biosciences

  STUDY DIRECTOR

Central Study Contacts

Neurocrine Medical Information Call Center

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: May 30, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); BE (3); FI (3); LA (3); HU (3); GB (3); CA (1)