Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- Registration Number
- NCT05536414
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 336
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Centanafadine + Placebo Placebo - Escitalopram + Placebo Placebo - Placebo + Placebo Placebo - Centanafadine + Escitalopram Escitalopram - Escitalopram + Placebo Escitalopram - Centanafadine + Placebo Centanafadine - Centanafadine + Escitalopram Centanafadine -
- Primary Outcome Measures
Name Time Method Change from baseline to Week 6 in Montgomery-Asberg Depression Rating Scale (MADRS) Total score. Baseline, Week 6
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (60)
Yuma CNS Research
🇺🇸Yuma, Arizona, United States
SanRo Clinical Research Group LLC
🇺🇸Bryant, Arkansas, United States
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
🇺🇸Lafayette, California, United States
Behavioral Research Specialists-California-Irvine
🇺🇸Glendale, California, United States
Synergy Research Centers - SRC - ERG - PPDS
🇺🇸Lemon Grove, California, United States
OM Research LLC - Lancaster - ClinEdge - PPDS
🇺🇸Lancaster, California, United States
ATP Clinical Research
🇺🇸Orange, California, 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
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
Flourish Research - Andersonville - PPDS
🇺🇸Chicago, Illinois, 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
South Florida Research Phase I - IV
🇺🇸Miami Springs, Florida, United States
Behavioral Clinical Research, Inc
🇺🇸North Miami, 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
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
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
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
Clinical Neuroscience Solutions Inc
🇺🇸Memphis, Tennessee, United States