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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

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

ArmDescriptionAssigned Intervention
Experimental
ACP-211 600 mg 		ACP-211 600 mg, administered orally twice weekly
  • Drug: ACP-211
    ACP-211 monotherapy
Experimental
ACP-211 300 mg 		ACP-211 300 mg, administered orally twice weekly
  • Drug: ACP-211
    ACP-211 monotherapy
Placebo Comparator
Placebo 		Matching placebo, administered orally twice weekly
  • Drug: Placebo
    Placebo control

Recruiting Locations

University of Alabama at Birmingham
Birmingham, Alabama 35294

Inland Psychiatric Medical Group
Chino, California 91710

PNS Clinical Research LLC dba ATP Clinical Research
Orange, California 92866

Mountain View Clinical Research
Denver, Colorado 80209

The Medici Medical Research
Hollywood, Florida 33021

Sandhill Research, LLC/DBA Accel Research Sites
Largo, Florida 33777

Clinical Neuroscience Solutions, Inc.
Orlando, Florida 32801

IPTB Clinical Research
Tampa, Florida 33629

Neuroscience Research Institute, Inc.
West Palm Beach, Florida 33407

Vitalix Clinical, Inc.
Worcester, Massachusetts 01608

Redbird Research LLC
Las Vegas, Nevada 89134

CenExel Hassman Research Institute, LLC
Marlton, New Jersey 08053

Integrative Clinical Trials LLC
Brooklyn, New York 11229

Neuro-Behavioral Clinical Research
North Canton, Ohio 44720

Dynamed Clinical Research LP d/b/a DM Clinical Research
Houston, Texas 77081

Olympus Clinical Research, LLC
Katy, Texas 77450

More Details

Status
Recruiting
Sponsor
ACADIA Pharmaceuticals Inc.

Study Contact

Sandy Filosi
+1(609) 250-6920
sfilosi@ACADIA-Pharm.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.