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New hope for tough depression? drug trial targets Non-Responders

NCT ID NCT07284667

Symptom relief Sponsor: ACADIA Pharmaceuticals Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 8 times

Summary

This study tests a new medicine called ACP-211 in adults with major depression who haven't gotten better with standard antidepressants. About 153 people will receive either the drug or a placebo for 28 days. The main goal is to see if ACP-211 reduces depression symptoms more than 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

About 153 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

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.

Inclusion Criteria: * Adults ≥18 and ≤65 years of age * Provides written informed consent * Clinical diagnosis of MDD * History of inadequate response to at least two antidepressants, with at least one inadequate response documented during the current episode * Currently treated with an approved antidepressant at a stable dose prior to Screening * MADRS total score ≥28, CGI-S score ≥4 , and QIDS-SR16 score ≥16 at Screening and Baseline * Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation Exclusion Criteria: * Current diagnosis of certain personality disorders or persistent depressive disorder * Recent substance use disorders, excluding caffeine or nicotine * Active suicidal risk or recent suicidal attempt * History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features * Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD * History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy) * Allergy or sensitivity to ketamine or esketamine * Significant cardiovascular disease * Positive history of hepatitis B, hepatitis C, or HIV infection * Unstable diabetes or uncontrolled medical conditions * Positive urine drug test for an illicit drug or cannabis * Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode * Recent initiation or change in psychotherapy Additional inclusion/exclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.

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Conditions

The condition(s) this trial relates to.

depressive disorder Depressive Disorder, Treatment-Resistant major depressive disorder

As listed by the trial registrant

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

Depressive disorder, treatment-resistant Major depressive disorder (MDD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Adams Clinical, Inc.

    RECRUITING

    Watertown, Massachusetts, 02472, United States

  • Alivation Research, LLC

    RECRUITING

    Lincoln, Nebraska, 68526, United States

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

  • Behavioral Research Specialists, LLC

    RECRUITING

    Glendale, California, 91107, United States

  • CenExel Hassman Research Institute, LLC

    WITHDRAWN

    Marlton, New Jersey, 08053, United States

  • Clinical Neuroscience Solutions, Inc.

    RECRUITING

    Orlando, Florida, 32801, United States

  • Dynamed Clinical Research LP d/b/a DM Clinical Research

    WITHDRAWN

    Houston, Texas, 77081, United States

  • Family Psychiatry of The Woodlands

    RECRUITING

    The Woodlands, Texas, 77381, United States

  • IPTB Clinical Research

    RECRUITING

    Tampa, Florida, 33629, United States

  • Inland Psychiatric Medical Group

    RECRUITING

    Chino, California, 91710, United States

  • Integrative Clinical Trials LLC

    RECRUITING

    Brooklyn, New York, 11229, United States

  • Kadima Neuropsychiatry Institute

    RECRUITING

    La Jolla, California, 92037, United States

  • Magnolia Clinical Research, LLC

    RECRUITING

    Cary, North Carolina, 27511, United States

  • Mountain View Clinical Research

    RECRUITING

    Denver, Colorado, 80209, United States

  • Neuro-Behavioral Clinical Research

    RECRUITING

    North Canton, Ohio, 44720, United States

  • Neuroscience Research Institute, Inc.

    RECRUITING

    West Palm Beach, Florida, 33407, United States

  • New Access Research and Medical Services, Inc.

    RECRUITING

    Fort Myers, Florida, 33901, United States

  • Olympus Clinical Research, LLC

    RECRUITING

    Katy, Texas, 77450, United States

  • PNS Clinical Research LLC dba ATP Clinical Research

    RECRUITING

    Orange, California, 92866, United States

  • Precise Research Centers

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Redbird Research LLC

    RECRUITING

    Las Vegas, Nevada, 89134, United States

  • Sandhill Research, LLC/DBA Accel Research Sites

    WITHDRAWN

    Largo, Florida, 33777, United States

  • St. Charles Psychiatric Associates, Inc. dba Midwest Research Group

    RECRUITING

    Saint Charles, Missouri, 63304, United States

  • The Medici Medical Research

    RECRUITING

    Hollywood, Florida, 33021, United States

  • University of Alabama at Birmingham

    WITHDRAWN

    Birmingham, Alabama, 35294, United States

  • Vitalix Clinical, Inc.

    RECRUITING

    Worcester, Massachusetts, 01608, United States

More trials for these conditions

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