Clinical trial NCT05203341: Study to Assess the Efficacy and Safety of NBI-1065845 in Adults With Major Depressive Disorder (MDD)
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of NBI-1065845 in Adult Subjects With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: Depression
MDD
Major Depressive Disorder
NBI-1065845
Mental Disorders
TAK-653
MADRS
SAVITRI
Lead sponsor: Neurocrine Biosciences
Sponsor class: INDUSTRY
First posted: 2022-01-24
Enrollment: 183
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: The purpose of this study is to evaluate the efficacy of NBI-1065845 compared with placebo in participants with MDD on improving symptoms of depression.


Eligibility criteria: Key Inclusion Criteria:

Participants must meet all of these criteria for inclusion in the study:

1. The participant has completed written informed consent.
2. At the time of signing the informed consent, participant must be 18 to 65 years of age, inclusive.
3. The participant has a primary diagnosis of recurrent Major Depressive Disorder (MDD) or persistent depressive disorder.
4. Participant must have had inadequate response to antidepressant treatment.
5. Participant must have a Total Hamilton Depression Rating Scale-17 Item (HAMD-17) score ≥ 22 at screening.
6. Participants currently receiving pharmacological treatment for depression must have been taking current antidepressant medication(s) for ≥8 weeks prior to screening. Subjects not currently receiving pharmacologic treatment for depression must have received the most recent antidepressant medication(s) for ≥8 weeks in the current episode of depression.
7. Participants must be willing and able to comply with all study procedures.

Key Exclusion Criteria:

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

1. Participant is pregnant or breastfeeding or plans to become pregnant during the study.
2. Participant has an unstable medical condition or unstable chronic disease.
3. Participant has a history of neurological abnormalities.
4. Participant has a current or prior psychiatric disorder that was the primary focus of treatment other than MDD.
5. The participant's depressive symptoms have previously demonstrated nonresponse to an adequate course of treatment with electroconvulsive therapy (ECT).
6. The participant has an alcohol or substance use disorder.
7. In the Investigator's opinion, the participant is not capable of adhering to the protocol requirements.

Primary outcomes:
measure: Change from Baseline in Total Montgomery Åsberg Depression Rating Scale (MADRS) Score at Day 28
timeFrame: Baseline, Day 28
Secondary outcomes:
measure: Change from Baseline in Total MADRS Score at Day 7, Day 14, and Day 56
timeFrame: Baseline, Days 7, 14, and 56
measure: Change from Baseline in Clinical Global Impression - Severity (CGI-S) Score at Day 28 and Day 56
timeFrame: Baseline, Days 28 and 56
measure: Response, defined as ≥50% decrease in MADRS from baseline, at Day 28 and Day 56
timeFrame: Baseline, Days 28 and 56
measure: Remission, defined as MADRS ≤10, at Days 28 and 56
timeFrame: Days 28 and 56
measure: Change from Baseline in Patient Health Questionnaire-9 (PHQ-9) Score at Day 28 and Day 56
timeFrame: Baseline, Days 28 and 56
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Neurocrine Clinical Site
state: Alabama
city: Huntsville
country: United States
facility: Neurocrine Clinical Site
state: Alabama
city: Riverside
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Diego
country: United States
facility: Neurocrine Clinical Site
state: California
city: San Francisco
country: United States
facility: Neurocrine Clinical Site
state: California
city: Torrance
country: United States
facility: Neurocrine Clinical Site
state: California
city: Hartford
country: United States
facility: Neurocrine Clinical Site
state: Connecticut
city: Palmetto Bay
country: United States
facility: Neurocrine Clinical Site
state: Florida
city: Gaithersburg
country: United States
facility: Neurocrine Clinical Site
state: Maryland
city: Weldon Spring
country: United States
facility: Neurocrine Clinical Site
state: Missouri
city: Columbus
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: North Canton
country: United States
facility: Neurocrine Clinical Site
state: Ohio
city: Oklahoma City
country: United States
facility: Neurocrine Clinical Site
state: Oklahoma
city: Memphis
country: United States
facility: Neurocrine Clinical Site
state: Tennessee
city: Dallas
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Houston
country: United States
facility: Neurocrine Clinical Site
state: Texas
city: Draper
country: United States
facility: Neurocrine Clinical Site
state: Utah
city: Plovdiv
country: Bulgaria
facility: Neurocrine Clinical Site
city: Ruse
country: Bulgaria
facility: Neurocrine Clinical Site
city: Sofia
country: Bulgaria
facility: Neurocrine Clinical Site
city: Tsarev Brod
country: Bulgaria
facility: Neurocrine Clinical Site
city: Varna
country: Bulgaria
facility: Neurocrine Clinical Site
city: Veliko Tarnovo
country: Bulgaria
facility: Neurocrine Clinical Site
city: Vratsa
country: Bulgaria
facility: Neurocrine Clinical Site
city: Kladno
country: Czechia
facility: Neurocrine Clinical Site
city: Plzen
country: Czechia
facility: Neurocrine Clinical Site
city: Praha 10
country: Czechia
facility: Neurocrine Clinical Site
city: Praha 6
country: Czechia
facility: Neurocrine Clinical Site
city: Praha 8
country: Czechia
facility: Neurocrine Clinical Site
city: Bełchatów
country: Poland
facility: Neurocrine Clinical Site
city: Chełmno
country: Poland
facility: Neurocrine Clinical Site
city: Gdańsk
country: Poland
facility: Neurocrine Clinical Site
city: Katowice
country: Poland
facility: Neurocrine Clinical Site
city: Košice
country: Slovakia
facility: Neurocrine Clinical Site
city: Rimavská Sobota
country: Slovakia
facility: Neurocrine Clinical Site
city: Trenčín
country: Slovakia
facility: Neurocrine Clinical Site
city: Vranov Nad Topľou
country: Slovakia
facility: Neurocrine Clinical Site
city: Göteborg
country: Sweden
facility: Neurocrine Clinical Site
city: Halmstad
country: Sweden
facility: Neurocrine Clinical Site
city: Lund
country: Sweden
facility: Neurocrine Clinical Site
city: Stockholm
country: Sweden
facility: Neurocrine Clinical Site
Study officials:
affiliation: Neurocrine Biosciences
name: Clinical Development Lead
role: STUDY_DIRECTOR
References: