Clinical trial NCT06267846: A Study to Evaluate the Efficacy and Safety of NBI-1070770 in Adults With Major Depressive Disorder
Official title: A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of NBI-1070770 in Adults With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
NBI-1070770
Neurocrine
Antidepressant
Depression
Montgomery-Åsberg Depression Rating Scale
MADRS
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2024-02-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy, safety, and tolerability of NBI-1070770 compared to placebo on improving symptoms of depression in participants with major depressive disorder (MDD).


Eligibility criteria: Key Inclusion Criteria:

Participants must meet all of the following inclusion criteria:

* Primary diagnosis of recurrent MDD or persistent MDD.
* Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening and must be willing and able to continue with current antidepressant medication(s).
* Participants must be willing and able to comply with all study procedures and restrictions.

Key Exclusion Criteria:

Participants will be excluded from the study if they meet any of the following criteria:

* Participant is pregnant or breastfeeding or plan to become pregnant during the study.
* Participant has an unstable medical condition or unstable chronic disease.
* Participant has a history of neurological abnormalities.
* Participant has a current or prior psychiatric disorder diagnosis that was the primary focus of treatment other than MDD.
* Participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy.
* Participant has an alcohol or substance use disorder.

Note: Other inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change in Total Montgomery-Åsberg Depression Rating Scale (MADRS) Score from Baseline to Day 5
timeFrame: Baseline, Day 5
Secondary outcomes:
measure: Change in Total MADRS Score from Baseline at Postbaseline Timepoints
timeFrame: Baseline, up to Day 49
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Rogers
country: United States
facility: Neurocrine Clinical Site
state: Arkansas
city: Lemon Grove
country: United States
facility: Neurocrine Clinical Site
state: California
city: Long Beach
country: United States
facility: Neurocrine Clinical Site
state: California
city: Hollywood
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Maitland
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Decatur
country: United States
facility: Neurocrine Clinical Site
state: Georgia
city: Savannah
country: United States
facility: Neurocrine Clinical Site
state: Georgia
city: Gaithersburg
country: United States
facility: Neurocrine Clinical Site
state: Maryland
city: Dayton
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: North Canton
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Richardson
country: United States
facility: Neurocrine Clinical Site
state: Texas
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: