Clinical trial NCT06786624: Study to Assess the Efficacy and Safety of NBI-1065845 as an Adjunctive Treatment in Participants With Major Depressive Disorder (MDD)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 as Adjunctive Treatment in Subjects With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: MDD
Depression
Major Depressive Disorder
NBI-1065845
TAK-653
MADRS
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2025-01-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from Baseline in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score at Day 56
timeFrame: Baseline, Day 56
Secondary outcomes:
measure: Change from Baseline in Sheehan Disability Scale (SDS) Total Score at Day 56
timeFrame: Baseline, Day 56
measure: Change from Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Day 56
timeFrame: Baseline, Day 56
Other outcomes:
Locations:
city: Orange
country: United States
facility: Neurocrine Clinical Site
state: California
city: Maitland
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Boston
country: United States
facility: Neurocrine Clinical Site
state: Massachusetts
city: Watertown
country: United States
facility: Neurocrine Clinical Site
state: Massachusetts
city: Avon Lake
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Everett
country: United States
facility: Neurocrine Clinical Site
state: Washington
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: