NCT05536414CompletedPhase 2
Trial of Centanafadine Efficacy and Safety as Monotherapy or as Adjunct to SSRI in Adults With Major Depressive Disorder
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
Source: ClinicalTrials.gov · Last updated 14 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 337 (actual)
- First submitted
- 7 Sept 2022
- Start date
- 12 Sept 2022
- Primary completion date
- 16 May 2025
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Diseases
- Depression
- NCT number
- NCT05536414
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 337
- From 12 Sept 2022 to the primary completion date, 16 May 2025
- 62 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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).
Other
- Subjects who report an inadequate response to more than 3 antidepressant treatments in the current episode.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (62)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atlanta Center for Medical Research - CenExel ACMR - PPDS Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| MTP Psychiatry, LLC Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| The Memory Clinic Coordinator of this site? Confirm its status | Bennington | United States | Unknown status |
| Northwest Clinical Trials Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| SPRI Clinical Trials, LLC - ERG - PPDS Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Integrative Clinical Trials - Hunt - PPDS Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Sanro Clinical Research Group, Llc Coordinator of this site? Confirm its status | Bryant | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Flourish Research - Andersonville - PPDS Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Patient Priority Clinical Sites LLC Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Alpine Research Organization, Inc Coordinator of this site? Confirm its status | Clinton | United States | Unknown status |
| CNS Clinical Research Group Coordinator of this site? Confirm its status | Coral Springs | United States | Unknown status |
| FutureSearch Trials of Dallas, LLC - IVY - PPDS Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| iResearch Atlanta - CenExel - PPDS Coordinator of this site? Confirm its status | Decatur | United States | Unknown status |
| InSite Clinical Research, LLC Coordinator of this site? Confirm its status | DeSoto | United States | Unknown status |
| Cedar Clinical Research - IVY - PPDS Coordinator of this site? Confirm its status | Draper | United States | Unknown status |
| Revive Research Institute Coordinator of this site? Confirm its status | Elgin | United States | Unknown status |
| Core Clinical Research Coordinator of this site? Confirm its status | Everett | United States | Unknown status |
| Precise Research Centers - ClinEdge - PPDS Coordinator of this site? Confirm its status | Flowood | United States | Unknown status |
| Gulfcoast Clinical Research Center Coordinator of this site? Confirm its status | Fort Myers | United States | Unknown status |
| Charak Clinical Research Center Coordinator of this site? Confirm its status | Garfield Heights | United States | Unknown status |
| Behavioral Research Specialists-California-Irvine Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Innovative Medical Research of Texas Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Houston Mind & Brain Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Red Oak Psychiatry Associates P A Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University Hills Clinical Research Coordinator of this site? Confirm its status | Irving | United States | Unknown status |
| Clinical NeuroScience Solutions Inc Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| OM Research LLC - Lancaster - ClinEdge - PPDS Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Synergy Research Centers - SRC - ERG - PPDS Coordinator of this site? Confirm its status | Lemon Grove | United States | Unknown status |
| Psych Atlanta Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Memphis | United States | Unknown status |
| South Florida Research Phase I - IV Coordinator of this site? Confirm its status | Miami Springs | United States | Unknown status |
| LLM Research - South Carolina Coordinator of this site? Confirm its status | Myrtle Beach | United States | Unknown status |
| Fieve Clinical Research Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Manhattan Behavioral Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS Coordinator of this site? Confirm its status | North Canton | United States | Unknown status |
| Behavioral Clinical Research, Inc Coordinator of this site? Confirm its status | North Miami | United States | Unknown status |
| American Medical Research Inc Coordinator of this site? Confirm its status | Oak Brook | United States | Unknown status |
| Psychiatric Care and Research Center Coordinator of this site? Confirm its status | O'Fallon | United States | Unknown status |
| Cutting Edge Research Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| NRC Research Institute - Orange - PPDS Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| ATP Clinical Research Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Clinical Neuroscience Solutions, Inc. Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Accelerated Clinical Trials, LLC Coordinator of this site? Confirm its status | Peachtree Corners | United States | Unknown status |
| AIM Trials Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Summit Research Network, Inc. - Portland - Headlands - PPDS Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Prospective Research Innovations Coordinator of this site? Confirm its status | Rancho Cucamonga | United States | Unknown status |
| Anderson Clinical Research - ClinEdge - PPDS Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Finger Lakes Clinical Research Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Lumos Clinical Research Coordinator of this site? Confirm its status | San Jose | United States | Unknown status |
| Syrentis Clinical Research Coordinator of this site? Confirm its status | Santa Ana | United States | Unknown status |
| Schuster Medical Research Institute Coordinator of this site? Confirm its status | Sherman Oaks | United States | Unknown status |
| Louisiana Clinical Research, LLC Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| Richmond Behavioral Associates Coordinator of this site? Confirm its status | Staten Island | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Viking Clinical Research Ltd Coordinator of this site? Confirm its status | Temecula | United States | Unknown status |
| Bio Behavioral Health Coordinator of this site? Confirm its status | Toms River | United States | Unknown status |
| Suburban Research Associates - ATLAS - West Chester - PPDS Coordinator of this site? Confirm its status | West Chester | United States | Unknown status |
| Grayline Clinical Drug Trials Coordinator of this site? Confirm its status | Wichita Falls | United States | Unknown status |
| Yuma CNS Research Coordinator of this site? Confirm its status | Yuma | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.