A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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?
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Inland Psychiatric Medical Group
RECRUITING
Chino
Colorado
Mountain View Clinical Research
RECRUITING
Denver
Florida
Sandhill Research, LLC/DBA Accel Research Sites
RECRUITING
Largo
Clinical Neuroscience Solutions, Inc.
RECRUITING
Orlando
IPTB Clinical Research
RECRUITING
Tampa
Massachusetts
Vitalix Clinical, Inc.
RECRUITING
Worcester
New Jersey
CenExel Hassman Research Institute, LLC
RECRUITING
Marlton
Nevada
Redbird Research LLC
RECRUITING
Las Vegas
New York
Integrative Clinical Trials LLC
RECRUITING
Brooklyn
Ohio
Neuro-Behavioral Clinical Research
RECRUITING
North Canton
Texas
Dynamed Clinical Research LP d/b/a DM Clinical Research