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

NCT ID: NCT07284667
Registry status: Recruiting
Study type: Not specified in the registry data
Phase: Phase 2
Sponsor: ACADIA Pharmaceuticals Inc.

Overview

ClinicalTrials.gov lists this study as Recruiting.

Enrollment: 153 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages: Not specified in the registry data
Sex: Not specified in the registry data
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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.

Study locations

26 study locations are listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: United States

Alabama, United States: 1
California, United States: 4
Colorado, United States: 1
Florida, United States: 6
Massachusetts, United States: 2
Mississippi, United States: 1
Missouri, United States: 1
Nebraska, United States: 1
Nevada, United States: 1
New Jersey, United States: 1
New York, United States: 1
North Carolina, United States: 1
Ohio, United States: 1
Texas, United States: 4

Sample of listed locations

University of Alabama at Birmingham — Birmingham, Alabama, 35294, United States — Site recruitment status not specified in the registry data
Inland Psychiatric Medical Group — Chino, California, 91710, United States — Site recruitment status not specified in the registry data
Behavioral Research Specialists, LLC — Glendale, California, 91107, United States — Site recruitment status not specified in the registry data
Kadima Neuropsychiatry Institute — La Jolla, California, 92037, United States — Site recruitment status not specified in the registry data
PNS Clinical Research LLC dba ATP Clinical Research — Orange, California, 92866, United States — Site recruitment status not specified in the registry data
Mountain View Clinical Research — Denver, Colorado, 80209, United States — Site recruitment status not specified in the registry data
New Access Research and Medical Services, Inc. — Fort Myers, Florida, 33901, United States — Site recruitment status not specified in the registry data
The Medici Medical Research — Hollywood, Florida, 33021, United States — Site recruitment status not specified in the registry data
Sandhill Research, LLC/DBA Accel Research Sites — Largo, Florida, 33777, United States — Site recruitment status not specified in the registry data
Clinical Neuroscience Solutions, Inc. — Orlando, Florida, 32801, United States — Site recruitment status not specified in the registry data
IPTB Clinical Research — Tampa, Florida, 33629, United States — Site recruitment status not specified in the registry data
Neuroscience Research Institute, Inc. — West Palm Beach, Florida, 33407, United States — Site recruitment status not specified in the registry data
Adams Clinical, Inc. — Watertown, Massachusetts, 02472, United States — Site recruitment status not specified in the registry data
Vitalix Clinical, Inc. — Worcester, Massachusetts, 01608, United States — Site recruitment status not specified in the registry data
Precise Research Centers — Flowood, Mississippi, 39232, United States — Site recruitment status not specified in the registry data
St. Charles Psychiatric Associates, Inc. dba Midwest Research Group — Saint Charles, Missouri, 63304, United States — Site recruitment status not specified in the registry data
Alivation Research, LLC — Lincoln, Nebraska, 68526, United States — Site recruitment status not specified in the registry data
Redbird Research LLC — Las Vegas, Nevada, 89134, United States — Site recruitment status not specified in the registry data
CenExel Hassman Research Institute, LLC — Marlton, New Jersey, 08053, United States — Site recruitment status not specified in the registry data
Integrative Clinical Trials LLC — Brooklyn, New York, 11229, United States — Site recruitment status not specified in the registry data
Magnolia Clinical Research, LLC — Cary, North Carolina, 27511, United States — Site recruitment status not specified in the registry data
Neuro-Behavioral Clinical Research — North Canton, Ohio, 44720, United States — Site recruitment status not specified in the registry data
Baylor College of Medicine — Houston, Texas, 77030, United States — Site recruitment status not specified in the registry data
Dynamed Clinical Research LP d/b/a DM Clinical Research — Houston, Texas, 77081, United States — Site recruitment status not specified in the registry data
Olympus Clinical Research, LLC — Katy, Texas, 77450, United States — Site recruitment status not specified in the registry data

Study details

Start date: November 14, 2025
Primary completion date: August 1, 2027
First posted: December 16, 2025

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT07284667
Registry last updated: September 14, 2026
QualifiedStudies registry data refreshed: September 21, 2026

View NCT07284667 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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