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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-30

Study Completion Date

2027-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NBI-1065845

NBI-1065845 administered orally once a day.

Group Type EXPERIMENTAL

NBI-1065845

Intervention Type DRUG

NBI-1065845 tablets

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo tablets

Interventions

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NBI-1065845

NBI-1065845 tablets

Intervention Type DRUG

Placebo

Matching placebo tablets

Intervention Type DRUG

Other Intervention Names

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TAK-653

Eligibility Criteria

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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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Development Lead

Role: STUDY_DIRECTOR

Neurocrine Biosciences

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Neurocrine Medical Information Call Center

Role: CONTACT

Phone: 1-877-641-3461

Email: [email protected]

Other Identifiers

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2024-519421-37-00

Identifier Type: CTIS

Identifier Source: secondary_id