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New depression pill shows promise in early trial

NCT ID NCT05536414

Symptom relief Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new drug, centanafadine, in 337 adults with major depression who hadn't responded well to at least one prior treatment. Some participants took the drug alone, others added it to their current antidepressant. The main goal was to see if it reduced depression symptoms over 6 weeks compared to a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

337 people

The number who actually took part.

Started

Sep 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Behavioral Symptoms Depression depressive disorder major depressive disorder mood disorder psychiatric disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Major depressive disorder

Contacts and locations

Locations

  • AIM Trials

    Plano, Texas, 75093-8346, United States

  • ATP Clinical Research

    Orange, California, 92866, United States

  • Accelerated Clinical Trials,LLC

    Peachtree Corners, Georgia, 30071-2655, United States

  • Alpine Research Organization, Inc

    Clinton, Utah, 84015-8563, United States

  • American Medical Research Inc

    Oak Brook, Illinois, 60523-1818, United States

  • Anderson Clinical Research - ClinEdge - PPDS

    Redlands, California, 92374-4555, United States

  • Atlanta Center for Medical Research - CenExel ACMR - PPDS

    Atlanta, Georgia, 30331, United States

  • Behavioral Clinical Research, Inc

    North Miami, Florida, 33161-5832, United States

  • Behavioral Research Specialists-California-Irvine

    Glendale, California, 91206-4282, United States

  • Bio Behavioral Health

    Toms River, New Jersey, 08755-6434, United States

  • CNS Clinical Research Group

    Coral Springs, Florida, 33067-4644, United States

  • Cedar Clinical Research - IVY - PPDS

    Draper, Utah, 84020-9884, United States

  • Charak Clinical Research Center

    Garfield Heights, Ohio, 44125-2946, United States

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida, 32256-6040, United States

  • Clinical Neuroscience Solutions Inc

    Orlando, Florida, 32801-2987, United States

  • Clinical Neuroscience Solutions Inc

    Memphis, Tennessee, 38119-4806, United States

  • Core Clinical Research

    Everett, Washington, 98201-4077, United States

  • Cutting Edge Research

    Oklahoma City, Oklahoma, 73116-1423, United States

  • Fieve Clinical Research

    New York, New York, 10017-1945, United States

  • Finger Lakes Clinical Research

    Rochester, New York, 14618-1609, United States

  • Flourish Research - Andersonville - PPDS

    Chicago, Illinois, 60640-2831, United States

  • FutureSearch Trials of Dallas, LLC - IVY - PPDS

    Dallas, Texas, 75251, United States

  • Grayline Clinical Drug Trials

    Wichita Falls, Texas, 76309-1608, United States

  • Gulfcoast Clinical Research Center

    Fort Myers, Florida, 33912-4367, United States

  • Houston Mind & Brain

    Houston, Texas, 77055-6349, United States

  • InSite Clinical Research, LLC

    DeSoto, Texas, 75115-2066, United States

  • Innovative Medical Research of Texas

    Houston, Texas, 77065-4776, United States

  • Integrative Clinical Trials - Hunt - PPDS

    Brooklyn, New York, 11229-3576, United States

  • LLM Research - South Carolina

    Myrtle Beach, South Carolina, 29577-5898, United States

  • Louisiana Clinical Research, LLC

    Shreveport, Louisiana, 71101-4603, United States

  • Lumos Clinical Research

    San Jose, California, 95124-4108, United States

  • MTP Psychiatry, LLC

    Baltimore, Maryland, 21229-1506, United States

  • Manhattan Behavioral Medicine

    New York, New York, 10036-4543, United States

  • NRC Research Institute - Orange - PPDS

    Orange, California, 92868-2847, United States

  • Neuro-Behavioral Clinical Research Inc - ClinEdge - PPDS

    North Canton, Ohio, 44720-1528, United States

  • Northwest Clinical Trials

    Boise, Idaho, 83704-8638, United States

  • OM Research LLC - Lancaster - ClinEdge - PPDS

    Lancaster, California, 93534-5504, United States

  • Patient Priority Clinical Sites LLC

    Cincinnati, Ohio, 45215-2123, United States

  • Precise Research Centers - ClinEdge - PPDS

    Flowood, Mississippi, 39232, United States

  • Prospective Research Innovations

    Rancho Cucamonga, California, 91730-4850, United States

  • Psych Atlanta

    Marietta, Georgia, 30060-2585, United States

  • Psychiatric Care and Research Center

    O'Fallon, Missouri, 63368-8223, United States

  • Red Oak Psychiatry Associates P A

    Houston, Texas, 77090-2607, United States

  • Revive Research Institute

    Elgin, Illinois, 60123-9215, United States

  • Richmond Behavioral Associates

    Staten Island, New York, 10314, United States

  • SPRI Clinical Trials, LLC - ERG - PPDS

    Brooklyn, New York, 11235-5660, United States

  • SanRo Clinical Research Group LLC

    Bryant, Arkansas, 72022-9252, United States

  • Schuster Medical Research Institute

    Sherman Oaks, California, 91403-1747, United States

  • South Florida Research Phase I - IV

    Miami Springs, Florida, 33166-7225, United States

  • Suburban Research Associates - ATLAS - West Chester - PPDS

    West Chester, Pennsylvania, 19380-4370, United States

  • Summit Research Network, Inc. - Portland - Headlands - PPDS

    Portland, Oregon, 97210-5354, United States

  • Sunwise Clinical Research, LLC - Lafayette - IVY - PPDS

    Lafayette, California, 94549, United States

  • Synergy Research Centers - SRC - ERG - PPDS

    Lemon Grove, California, 91945-2956, United States

  • Syrentis Clinical Research

    Santa Ana, California, 92705-8675, United States

  • The Memory Clinic

    Bennington, Vermont, 05201-9810, United States

  • University Hills Clinical Research

    Irving, Texas, 75062-2762, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219-2498, United States

  • University of South Florida

    Tampa, Florida, 33613-4706, United States

  • University of Virginia

    Charlottesville, Virginia, 22903-9353, United States

  • Viking Clinical Research Ltd

    Temecula, California, 92591-5285, United States

  • Yuma CNS Research

    Yuma, Arizona, 85365-4905, United States

  • iResearch Atlanta - CenExel - PPDS

    Decatur, Georgia, 30030-3438, United States

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