ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Recruiting · NCT07284667 · Interventional (participants receive a specific treatment) · Lead sponsor: ACADIA Pharmaceuticals Inc.
View the official record on ClinicalTrials.gov →Interventions studied
ACP-211Placebo
What this trial is about
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?
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
26 locations listed across 14 US states.
- University of Alabama at Birmingham - Birmingham, Alabama, United States
- Inland Psychiatric Medical Group - Chino, California, United States
- Behavioral Research Specialists, LLC - Glendale, California, United States
- Kadima Neuropsychiatry Institute - La Jolla, California, United States
- PNS Clinical Research LLC dba ATP Clinical Research - Orange, California, United States
- Mountain View Clinical Research - Denver, Colorado, United States
- New Access Research and Medical Services, Inc. - Fort Myers, Florida, United States
- The Medici Medical Research - Hollywood, Florida, 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
- Neuroscience Research Institute, Inc. - West Palm Beach, Florida, United States
- Adams Clinical, Inc. - Watertown, Massachusetts, United States
- Vitalix Clinical, Inc. - Worcester, Massachusetts, United States
- Precise Research Centers - Flowood, Mississippi, United States
- St. Charles Psychiatric Associates, Inc. dba Midwest Research Group - Saint Charles, Missouri, United States
- Alivation Research, LLC - Lincoln, Nebraska, 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
- Magnolia Clinical Research, LLC - Cary, North Carolina, United States
- Neuro-Behavioral Clinical Research - North Canton, Ohio, United States
- Baylor College of Medicine - Houston, Texas, United States
- Dynamed Clinical Research LP d/b/a DM Clinical Research - Houston, Texas, United States
- Olympus Clinical Research, LLC - Katy, Texas, United States
- Family Psychiatry of The Woodlands - The Woodlands, Texas, United States