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ACP-211 Monotherapy for Major Depressive Disorder

This study is looking into whether ACP-211 can help adults with major depressive disorder (MDD) who haven't found enough relief from other antidepressant treatments. This includes people with treatment-resistant depression. Researchers want to see if ACP-211 works better than a placebo (a pill with no medicine) to reduce depression symptoms, and what side effects people might experience. You could be eligible if you are between 18 and 65 years old, have a diagnosis of MDD, and have not responded well to at least two previous antidepressants. The study aims to enroll 153 participants and will measure changes in depression symptoms using a scale called MADRS after 28 days. The current status of this study is unclear.

Study design
This is an interventional study comparing ACP-211 to a placebo. It plans to enroll 153 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Day 28, suggesting follow-up for at least this duration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07284667

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

Recruiting
PHASE2Ages 18–65InterventionalTreatment
ACADIA Pharmaceuticals Inc.
~153 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:ACP-211Placebo

At a glance

Recruiting sites
22 of 26 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
Measured over Baseline and Day 28

Conditions

Major Depressive Disorder (MDD)
Depressive Disorder, Treatment-Resistant

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Where it's being run

26 sites across 14 states
Florida6
California4
Texas4
Massachusetts2
Alabama1
Colorado1
Mississippi1
Missouri1

Who to contact

Sandy Filosi
[email protected]
+1(609) 250-6920
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28Baseline and Day 28

    The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity.