ACP-211 alone for adults whose depression hasn't improved with antidepressants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, randomized, double-blind trial comparing ACP-211 monotherapy to placebo in adults aged 18–65 with major depressive disorder who have not responded adequately to at least two antidepressants. Eligible participants must be on a stable approved antidepressant dose and have moderate-to-severe symptoms at screening (MADRS ≥28, CGI-S ≥4, QIDS-SR16 ≥16). The study will measure changes in depressive symptom scores over the treatment period and closely monitor adverse events. Results will compare symptom improvement and safety between the ACP-211 and placebo groups.

Why it matters

Who can join: the full rules

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 ≥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 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.

Where it's running

• Inland Psychiatric Medical Group
  Chino, California, United States Recruiting
• Behavioral Research Specialists, LLC
  Glendale, California, United States Recruiting
• Kadima Neuropsychiatry Institute
  La Jolla, California, United States Recruiting
• PNS Clinical Research LLC dba ATP Clinical Research
  Orange, California, United States Recruiting
• Focus Clinical Research, LLC d/b/a Alliance Clinical West Hills
  West Hills, California, United States Recruiting
• Mountain View Clinical Research
  Denver, Colorado, United States Recruiting

Study contacts

• Study coordinator: Sandy Filosi
• Email: sfilosi@ACADIA-Pharm.com
• Phone: +1(609) 250-6920

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.