RecruitingPhase 2NCT07284667

ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response

A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment


Sponsor

ACADIA Pharmaceuticals Inc.

Enrollment

153 participants

Start Date

Nov 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (MDD) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD). The main questions the study aims to answer are: * Does ACP-211 work better than a placebo (a look-alike capsule with no medicine) to reduce symptoms of depression? * What adverse events do participants have when taking ACP-211?


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing ACP-211, a new drug, in adults with major depressive disorder (MDD) who have not responded well enough to at least two different antidepressants — sometimes called treatment-resistant depression. **You may be eligible if...** - You are between 18 and 65 years old - You have a clinical diagnosis of major depressive disorder (MDD) - You have not had an adequate response to at least 2 antidepressants, including at least one failure during your current depressive episode - You are currently taking an approved antidepressant at a stable dose - Your depression symptoms are severe based on standard rating scales (MADRS ≥28, CGI-S ≥4, QIDS-SR16 ≥16) - If you can become pregnant, you have a negative pregnancy test and agree to use contraception; males must use barrier protection **You may NOT be eligible if...** - You have certain personality disorders or persistent depressive disorder - You have had a recent substance use disorder (excluding caffeine or nicotine) - You are pregnant or unwilling to use contraception - You do not meet the severity thresholds on the depression rating scales Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGACP-211

ACP-211 monotherapy

DRUGPlacebo

Placebo control


Locations(13)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Inland Psychiatric Medical Group

Chino, California, United States

Mountain View Clinical Research

Denver, Colorado, United States

Sandhill Research, LLC/DBA Accel Research Sites

Largo, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

IPTB Clinical Research

Tampa, Florida, United States

Vitalix Clinical, Inc.

Worcester, Massachusetts, United States

Redbird Research LLC

Las Vegas, Nevada, United States

CenExel Hassman Research Institute, LLC

Marlton, New Jersey, United States

Integrative Clinical Trials LLC

Brooklyn, New York, United States

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States

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

Houston, Texas, United States

Olympus Clinical Research, LLC

Katy, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07284667


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