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) - 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.
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 5336537, California 5332921 91710
Chino 5336537, California 5332921 91710
Clinical Neuroscience Solutions, Inc.
Orlando 4167147, Florida 4155751 32801
Orlando 4167147, Florida 4155751 32801
IPTB Clinical Research
Tampa 4174757, Florida 4155751 33629
Tampa 4174757, Florida 4155751 33629
CenExel Hassman Research Institute, LLC
Marlton 4502911, New Jersey 5101760 08053
Marlton 4502911, New Jersey 5101760 08053
Integrative Clinical Trials LLC
Brooklyn 5110302, New York 5128638 11229
Brooklyn 5110302, New York 5128638 11229
Neuro-Behavioral Clinical Research
North Canton 5164706, Ohio 5165418 44720
North Canton 5164706, Ohio 5165418 44720
More Details
- Status
- Recruiting
- Sponsor
- ACADIA Pharmaceuticals Inc.