Clinical trial NCT05536414: Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depressive Disorder
Keywords: MDD
Centanafadine
SSRI
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 337
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: This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-arm trial to assess the efficacy, safety, and tolerability of centanafadine once-daily (QD) extended-release (XR) capsules for the treatment of adult subjects diagnosed with Major Depressive Disorder (MDD).

The trial will evaluate the efficacy and safety of centanafadine QD XR capsules as monotherapy or as adjunct to the selective serotonin reuptake inhibitor (SSRI), escitalopram.


Eligibility criteria: Key Inclusion Criteria:

* Male and Female subjects between 18-65 years of age, with a primary diagnosis of major depressive disorder and in a current major depressive episode.
* History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.

Key Exclusion Criteria:

* Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
* Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
* Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
* Sexually active subjects, who could become pregnant, not agreeing to practice 2 sponsor approved methods of birth control or remain abstinent during the trial and for 30 days (females) or 90 days (males) after last dose of study drug.

Primary outcomes:
measure: Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score.
timeFrame: Baseline, Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Yuma
country: United States
facility: Yuma CNS Research
state: Arizona
city: Bryant
country: United States
facility: SanRo Clinical Research Group LLC
state: Arkansas
city: Glendale
country: United States
facility: Behavioral Research Specialists-California-Irvine
state: California
city: Lafayette
country: United States
facility: Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
state: California
city: Lancaster
country: United States
facility: OM Research LLC - Lancaster - ClinEdge - PPDS
state: California
city: Lemon Grove
country: United States
facility: Synergy Research Centers - SRC - ERG - PPDS
state: California
city: Orange
country: United States
facility: ATP Clinical Research
state: California
city: Orange
country: United States
facility: NRC Research Institute - Orange - PPDS
state: California
city: Rancho Cucamonga
country: United States
facility: Prospective Research Innovations
state: California
city: Redlands
country: United States
facility: Anderson Clinical Research - ClinEdge - PPDS
state: California
city: San Jose
country: United States
facility: Lumos Clinical Research
state: California
city: Santa Ana
country: United States
facility: Syrentis Clinical Research
state: California
city: Sherman Oaks
country: United States
facility: Schuster Medical Research Institute
state: California
city: Temecula
country: United States
facility: Viking Clinical Research Ltd
state: California
city: Coral Springs
country: United States
facility: CNS Clinical Research Group
state: Florida
city: Fort Myers
country: United States
facility: Gulfcoast Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Miami Springs
country: United States
facility: South Florida Research Phase I - IV
state: Florida
city: North Miami
country: United States
facility: Behavioral Clinical Research, Inc
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Atlanta
country: United States
facility: Atlanta Center for Medical Research - CenExel ACMR - PPDS
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta - CenExel - PPDS
state: Georgia
city: Marietta
country: United States
facility: Psych Atlanta
state: Georgia
city: Peachtree Corners
country: United States
facility: Accelerated Clinical Trials,LLC
state: Georgia
city: Boise
country: United States
facility: Northwest Clinical Trials
state: Idaho
city: Chicago
country: United States
facility: Flourish Research - Andersonville - PPDS
state: Illinois
city: Elgin
country: United States
facility: Revive Research Institute
state: Illinois
city: Oak Brook
country: United States
facility: American Medical Research Inc
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Clinical Research, LLC
state: Louisiana
city: Baltimore
country: United States
facility: MTP Psychiatry, LLC
state: Maryland
city: Flowood
country: United States
facility: Precise Research Centers - ClinEdge - PPDS
state: Mississippi
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Brooklyn
country: United States
facility: Integrative Clinical Trials - Hunt - PPDS
state: New York
city: Brooklyn
country: United States
facility: SPRI Clinical Trials, LLC - ERG - PPDS
state: New York
city: New York
country: United States
facility: Fieve Clinical Research
state: New York
city: New York
country: United States
facility: Manhattan Behavioral Medicine
state: New York
city: Rochester
country: United States
facility: Finger Lakes Clinical Research
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Cincinnati
country: United States
facility: Patient Priority Clinical Sites LLC
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Garfield Heights
country: United States
facility: Charak Clinical Research Center
state: Ohio
city: North Canton
country: United States
facility: Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS
state: Ohio
city: Oklahoma City
country: United States
facility: Cutting Edge Research
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network, Inc. - Portland - Headlands - PPDS
state: Oregon
city: West Chester
country: United States
facility: Suburban Research Associates - ATLAS - West Chester - PPDS
state: Pennsylvania
city: Myrtle Beach
country: United States
facility: LLM Research - South Carolina
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc
state: Tennessee
city: Dallas
country: United States
facility: FutureSearch Trials of Dallas, LLC - IVY - PPDS
state: Texas
city: DeSoto
country: United States
facility: InSite Clinical Research, LLC
state: Texas
city: Houston
country: United States
facility: Houston Mind & Brain
state: Texas
city: Houston
country: United States
facility: Innovative Medical Research of Texas
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates P A
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
city: Plano
country: United States
facility: AIM Trials
state: Texas
city: Wichita Falls
country: United States
facility: Grayline Clinical Drug Trials
state: Texas
city: Clinton
country: United States
facility: Alpine Research Organization, Inc
state: Utah
city: Draper
country: United States
facility: Cedar Clinical Research - IVY - PPDS
state: Utah
city: Bennington
country: United States
facility: The Memory Clinic
state: Vermont
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
Study officials:
References: