Actively Recruiting
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Led by ACADIA Pharmaceuticals Inc. · Updated on 2026-05-08
153
Participants Needed
16
Research Sites
93 weeks
Total Duration
On this page
AI-Summary
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?
CONDITIONS
Official Title
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults and 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 , CGI-S score , and QIDS-SR16 score 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
You will not qualify if you...
- 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)
- Documented non-response to ADT, including ketamine or esketamine
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 16 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Inland Psychiatric Medical Group
Chino, California, United States, 91710
Actively Recruiting
3
PNS Clinical Research LLC dba ATP Clinical Research
Orange, California, United States, 92866
Actively Recruiting
4
Mountain View Clinical Research
Denver, Colorado, United States, 80209
Actively Recruiting
5
The Medici Medical Research
Hollywood, Florida, United States, 33021
Actively Recruiting
6
Sandhill Research, LLC/DBA Accel Research Sites
Largo, Florida, United States, 33777
Actively Recruiting
7
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
Actively Recruiting
8
IPTB Clinical Research
Tampa, Florida, United States, 33629
Actively Recruiting
9
Neuroscience Research Institute, Inc.
West Palm Beach, Florida, United States, 33407
Actively Recruiting
10
Vitalix Clinical, Inc.
Worcester, Massachusetts, United States, 01608
Actively Recruiting
11
Redbird Research LLC
Las Vegas, Nevada, United States, 89134
Actively Recruiting
12
CenExel Hassman Research Institute, LLC
Marlton, New Jersey, United States, 08053
Actively Recruiting
13
Integrative Clinical Trials LLC
Brooklyn, New York, United States, 11229
Actively Recruiting
14
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
15
Dynamed Clinical Research LP d/b/a DM Clinical Research
Houston, Texas, United States, 77081
Actively Recruiting
16
Olympus Clinical Research, LLC
Katy, Texas, United States, 77450
Actively Recruiting
Research Team
S
Sandy Filosi
CONTACT
L
Lori Lykens
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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