ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Purpose
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?
Conditions
- Major Depressive Disorder (MDD)
- Depressive Disorder, Treatment-Resistant
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental ACP-211 600 mg |
ACP-211 600 mg, administered orally twice weekly |
|
|
Experimental ACP-211 300 mg |
ACP-211 300 mg, administered orally twice weekly |
|
|
Placebo Comparator Placebo |
Matching placebo, administered orally twice weekly |
|
Recruiting Locations
Inland Psychiatric Medical Group
Chino, California 91710
Chino, California 91710
Behavioral Research Specialists, LLC
Glendale, California 91107
Glendale, California 91107
Kadima Neuropsychiatry Institute
La Jolla, California 92037
La Jolla, California 92037
PNS Clinical Research LLC dba ATP Clinical Research
Orange, California 92866
Orange, California 92866
Mountain View Clinical Research
Denver, Colorado 80209
Denver, Colorado 80209
New Access Research and Medical Services, Inc.
Fort Myers, Florida 33901
Fort Myers, Florida 33901
The Medici Medical Research
Hollywood, Florida 33021
Hollywood, Florida 33021
Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801
Orlando, Florida 32801
IPTB Clinical Research
Tampa, Florida 33629
Tampa, Florida 33629
Neuroscience Research Institute, Inc.
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
Adams Clinical, Inc.
Watertown, Massachusetts 02472
Watertown, Massachusetts 02472
Vitalix Clinical, Inc.
Worcester, Massachusetts 01608
Worcester, Massachusetts 01608
Precise Research Centers
Flowood, Mississippi 39232
Flowood, Mississippi 39232
St. Charles Psychiatric Associates, Inc. dba Midwest Research Group
Saint Charles, Missouri 63304
Saint Charles, Missouri 63304
Alivation Research, LLC
Lincoln, Nebraska 68526
Lincoln, Nebraska 68526
Redbird Research LLC
Las Vegas, Nevada 89134
Las Vegas, Nevada 89134
Integrative Clinical Trials LLC
Brooklyn, New York 11229
Brooklyn, New York 11229
Magnolia Clinical Research, LLC
Cary, North Carolina 27511
Cary, North Carolina 27511
Neuro-Behavioral Clinical Research
North Canton, Ohio 44720
North Canton, Ohio 44720
Baylor College of Medicine
Houston, Texas 77030
Houston, Texas 77030
Olympus Clinical Research, LLC
Katy, Texas 77450
Katy, Texas 77450
Family Psychiatry of The Woodlands
The Woodlands, Texas 77381
The Woodlands, Texas 77381
More Details
- Status
- Recruiting
- Sponsor
- ACADIA Pharmaceuticals Inc.