COMPLETED

Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder

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Conditions

Major Depressive DisorderMDDCentanafadineSSRIDepressive DisorderDepressionDepressive Disorder, MajorMood DisordersMental DisordersBehavioral Symptoms

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-09-12
Study Completion:2025-05-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05536414

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * History of an inadequate response to at least 1 and no more than 3 antidepressant treatments in the current major depressive episode.
  1. * Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
  2. * Subjects with a lifetime history of schizophrenia spectrum or other psychotic disorder, bipolar or related disorder, neurocognitive disorder, or personality disorder.
  3. * Subjects with a current diagnosis of post-traumatic stress disorder, obsessive compulsive disorder, panic disorder, or eating disorder (including anorexia nervosa or bulimia).
  4. * 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.

Contacts and Locations

Study Locations (Sites)

Yuma CNS Research
Yuma, Arizona, 85365-4905
United States
SanRo Clinical Research Group LLC
Bryant, Arkansas, 72022-9252
United States
Behavioral Research Specialists-California-Irvine
Glendale, California, 91206-4282
United States
Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS
Lafayette, California, 94549
United States
OM Research LLC - Lancaster - ClinEdge - PPDS
Lancaster, California, 93534-5504
United States
Synergy Research Centers - SRC - ERG - PPDS
Lemon Grove, California, 91945-2956
United States
ATP Clinical Research
Orange, California, 92866
United States
NRC Research Institute - Orange - PPDS
Orange, California, 92868-2847
United States
Prospective Research Innovations
Rancho Cucamonga, California, 91730-4850
United States
Anderson Clinical Research - ClinEdge - PPDS
Redlands, California, 92374-4555
United States
Lumos Clinical Research
San Jose, California, 95124-4108
United States
Syrentis Clinical Research
Santa Ana, California, 92705-8675
United States
Schuster Medical Research Institute
Sherman Oaks, California, 91403-1747
United States
Viking Clinical Research Ltd
Temecula, California, 92591-5285
United States
CNS Clinical Research Group
Coral Springs, Florida, 33067-4644
United States
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912-4367
United States
Clinical Neuroscience Solutions Inc
Jacksonville, Florida, 32256-6040
United States
South Florida Research Phase I - IV
Miami Springs, Florida, 33166-7225
United States
Behavioral Clinical Research, Inc
North Miami, Florida, 33161-5832
United States
Clinical Neuroscience Solutions Inc
Orlando, Florida, 32801-2987
United States
University of South Florida
Tampa, Florida, 33613-4706
United States
Atlanta Center for Medical Research - CenExel ACMR - PPDS
Atlanta, Georgia, 30331
United States
iResearch Atlanta - CenExel - PPDS
Decatur, Georgia, 30030-3438
United States
Psych Atlanta
Marietta, Georgia, 30060-2585
United States
Accelerated Clinical Trials,LLC
Peachtree Corners, Georgia, 30071-2655
United States
Northwest Clinical Trials
Boise, Idaho, 83704-8638
United States
Flourish Research - Andersonville - PPDS
Chicago, Illinois, 60640-2831
United States
Revive Research Institute
Elgin, Illinois, 60123-9215
United States
American Medical Research Inc
Oak Brook, Illinois, 60523-1818
United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71101-4603
United States
MTP Psychiatry, LLC
Baltimore, Maryland, 21229-1506
United States
Precise Research Centers - ClinEdge - PPDS
Flowood, Mississippi, 39232
United States
Psychiatric Care and Research Center
O'Fallon, Missouri, 63368-8223
United States
Bio Behavioral Health
Toms River, New Jersey, 08755-6434
United States
Integrative Clinical Trials - Hunt - PPDS
Brooklyn, New York, 11229-3576
United States
SPRI Clinical Trials, LLC - ERG - PPDS
Brooklyn, New York, 11235-5660
United States
Fieve Clinical Research
New York, New York, 10017-1945
United States
Manhattan Behavioral Medicine
New York, New York, 10036-4543
United States
Finger Lakes Clinical Research
Rochester, New York, 14618-1609
United States
Richmond Behavioral Associates
Staten Island, New York, 10314
United States
Patient Priority Clinical Sites LLC
Cincinnati, Ohio, 45215-2123
United States
University of Cincinnati
Cincinnati, Ohio, 45219-2498
United States
Charak Clinical Research Center
Garfield Heights, Ohio, 44125-2946
United States
Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS
North Canton, Ohio, 44720-1528
United States
Cutting Edge Research
Oklahoma City, Oklahoma, 73116-1423
United States
Summit Research Network, Inc. - Portland - Headlands - PPDS
Portland, Oregon, 97210-5354
United States
Suburban Research Associates - ATLAS - West Chester - PPDS
West Chester, Pennsylvania, 19380-4370
United States
LLM Research - South Carolina
Myrtle Beach, South Carolina, 29577-5898
United States
Clinical Neuroscience Solutions Inc
Memphis, Tennessee, 38119-4806
United States
FutureSearch Trials of Dallas, LLC - IVY - PPDS
Dallas, Texas, 75251
United States
InSite Clinical Research, LLC
DeSoto, Texas, 75115-2066
United States
Houston Mind & Brain
Houston, Texas, 77055-6349
United States
Innovative Medical Research of Texas
Houston, Texas, 77065-4776
United States
Red Oak Psychiatry Associates P A
Houston, Texas, 77090-2607
United States
University Hills Clinical Research
Irving, Texas, 75062-2762
United States
AIM Trials
Plano, Texas, 75093-8346
United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309-1608
United States
Alpine Research Organization, Inc
Clinton, Utah, 84015-8563
United States
Cedar Clinical Research - IVY - PPDS
Draper, Utah, 84020-9884
United States
The Memory Clinic
Bennington, Vermont, 05201-9810
United States
University of Virginia
Charlottesville, Virginia, 22903-9353
United States
Core Clinical Research
Everett, Washington, 98201-4077
United States

Collaborators and Investigators

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-12
Study Completion Date2025-05-16

Study Record Updates

Study Start Date2022-09-12
Study Completion Date2025-05-16

Terms related to this study

Keywords Provided by Researchers

  • MDD
  • Centanafadine
  • SSRI
  • Depressive Disorder
  • Depression
  • Depressive Disorder, Major
  • Mood Disorders
  • Mental Disorders
  • Behavioral Symptoms

Additional Relevant MeSH Terms

  • Major Depressive Disorder