Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
NCT ID: NCT05536414
Last Updated: 2025-05-30
Study Results
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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COMPLETED
PHASE2
337 participants
INTERVENTIONAL
2022-09-12
2025-05-16
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Centanafadine + Placebo
Centanafadine
capsule
Placebo
capsule
Centanafadine + Escitalopram
Centanafadine
capsule
Escitalopram
capsule
Escitalopram + Placebo
Escitalopram
capsule
Placebo
capsule
Placebo + Placebo
Placebo
capsule
Interventions
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Centanafadine
capsule
Escitalopram
capsule
Placebo
capsule
Eligibility Criteria
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Inclusion Criteria
* History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
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Locations
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Yuma CNS Research
Yuma, Arizona, United States
SanRo Clinical Research Group LLC
Bryant, Arkansas, United States
Behavioral Research Specialists-California-Irvine
Glendale, California, United States
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
Lafayette, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, United States
Synergy Research Centers - SRC - ERG - PPDS
Lemon Grove, California, United States
ATP Clinical Research
Orange, California, United States
NRC Research Institute - Orange - PPDS
Orange, California, United States
Prospective Research Innovations
Rancho Cucamonga, California, United States
Anderson Clinical Research - ClinEdge - PPDS
Redlands, California, United States
Lumos Clinical Research
San Jose, California, United States
Syrentis Clinical Research
Santa Ana, California, United States
Schuster Medical Research Institute
Sherman Oaks, California, United States
Viking Clinical Research Ltd
Temecula, California, United States
CNS Clinical Research Group
Coral Springs, Florida, United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, United States
South Florida Research Phase I - IV
Miami Springs, Florida, United States
Behavioral Clinical Research, Inc
North Miami, Florida, United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
Atlanta Center for Medical Research - CenExel ACMR - PPDS
Atlanta, Georgia, United States
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia, United States
Psych Atlanta
Marietta, Georgia, United States
Accelerated Clinical Trials,LLC
Peachtree Corners, Georgia, United States
Northwest Clinical Trials
Boise, Idaho, United States
Flourish Research - Andersonville - PPDS
Chicago, Illinois, United States
Revive Research Institute
Elgin, Illinois, United States
American Medical Research Inc
Oak Brook, Illinois, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, United States
MTP Psychiatry, LLC
Baltimore, Maryland, United States
Precise Research Centers - ClinEdge - PPDS
Flowood, Mississippi, United States
Psychiatric Care and Research Center
O'Fallon, Missouri, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Integrative Clinical Trials - Hunt - PPDS
Brooklyn, New York, United States
SPRI Clinical Trials, LLC - ERG - PPDS
Brooklyn, New York, United States
Fieve Clinical Research
New York, New York, United States
Manhattan Behavioral Medicine
New York, New York, United States
Finger Lakes Clinical Research
Rochester, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Charak Clinical Research Center
Garfield Heights, Ohio, United States
Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS
North Canton, Ohio, United States
Cutting Edge Research
Oklahoma City, Oklahoma, United States
Summit Research Network, Inc. - Portland - Headlands - PPDS
Portland, Oregon, United States
Suburban Research Associates - ATLAS - West Chester - PPDS
West Chester, Pennsylvania, United States
LLM Research - South Carolina
Myrtle Beach, South Carolina, United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, United States
FutureSearch Trials of Dallas, LLC - IVY - PPDS
Dallas, Texas, United States
InSite Clinical Research, LLC
DeSoto, Texas, United States
Houston Mind & Brain
Houston, Texas, United States
Innovative Medical Research of Texas
Houston, Texas, United States
Red Oak Psychiatry Associates P A
Houston, Texas, United States
University Hills Clinical Research
Irving, Texas, United States
AIM Trials
Plano, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Alpine Research Organization, Inc
Clinton, Utah, United States
Cedar Clinical Research - IVY - PPDS
Draper, Utah, United States
The Memory Clinic
Bennington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Core Clinical Research
Everett, Washington, United States
Countries
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Other Identifiers
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405-201-00062
Identifier Type: -
Identifier Source: org_study_id
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