ACP-211 for Adults With Depression That Has Not Improved on Antidepressants
Tests ACP-211 against placebo in adults whose depression did not improve with antidepressants.
Plain-language title generated from the registry record
Registry title: ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Key facts
- Where
- Birmingham, Brooklyn, Cary, Chino, Denver, Flowood, Fort Myers, Glendale, Hollywood, Houston, Katy, La Jolla, Largo, Las Vegas, Lincoln, Marlton, North Canton, Orange, Orlando, Saint Charles, Salt Lake City, Tampa, The Woodlands, Watertown, West Hills, West Palm Beach, and Worcester, United StatesSee the 28 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07284667, who can take part
Where in United States
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
- Integrative Clinical Trials, LLCBrooklyn, United StatesTaking people
- Magnolia Clinical Research LLCCary, United StatesTaking people
- Inland Psychiatric Medical Group.Chino, United StatesTaking people
- Mountain View Clinical ResearchDenver, United StatesTaking people
- Precise Research CentersFlowood, United StatesTaking people
- New Access Research and Medical Services, Inc.Fort Myers, United StatesTaking people
- Behavioral Research Specialists, LLCGlendale, United StatesTaking people
- The Medici Medical ResearchHollywood, United StatesTaking people
- Baylor College of MedicineHouston, United StatesTaking people
- Dynamed Clinical Research LP d/b/a DM Clinical ResearchHouston, United StatesNo longer taking part
- Olympus Clinical Research, LLCKaty, United StatesTaking people
- Kadima Neuropsychiatry InstituteLa Jolla, United StatesTaking people
- Sandhill Research, LLC/DBA Accel Research SitesLargo, United StatesNo longer taking part
- Redbird Research, LLCLas Vegas, United StatesTaking people
- Alivation Research, LLCLincoln, United StatesTaking people
- CenExel Hassman Research Institute, LLCMarlton, United StatesNo longer taking part
- Neuro-Behavioral Clinical ResearchNorth Canton, United StatesTaking people
- PNS Clinical Research LLC dba ATP Clinical ResearchOrange, United StatesTaking people
- Clinical Neuroscience Solutions, Inc.Orlando, United StatesTaking people
- St. Charles Psychiatric Associates, Inc. dba Midwest Research GroupSaint Charles, United StatesTaking people
- Aura WellnessSalt Lake City, United StatesTaking people
- IPTB Clinical ResearchTampa, United StatesTaking people
- Family Psychiatry of The WoodlandsThe Woodlands, United StatesTaking people
- Adams Clinical, Inc.Watertown, United StatesTaking people
- Focus Clinical Research, LLC d/b/a Alliance Clinical West HillsWest Hills, United StatesTaking people
- Neuroscience Research Institute, Inc.West Palm Beach, United StatesTaking people
- Vitalix Clinical, IncWorcester, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- ACADIA Pharmaceuticals Inc.
- Trial code
- NCT07284667
- Record updated
- 5 November 2026
- Original description
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).Read full original descriptionShow less
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
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?
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 ≥14 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: Positive urine drug test for an illicit drug or cannabis; Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode; Current diagnosis of certain personality disorders or persistent depressive disorder; Recent substance use disorders, excluding caffeine or nicotine; 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; Active suicidal risk or recent suicidal attempt; 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.