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
ACADIA Pharmaceuticals Inc.
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
- Age range
- 18–65 years
- Sex
- All
- 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 a…
Interventions
- DrugACP-211
ACP-211 monotherapy
- DrugPlacebo
Placebo control
Locations (16)
- University of Alabama at BirminghamBirmingham, Alabama
- Inland Psychiatric Medical GroupChino, California
- PNS Clinical Research LLC dba ATP Clinical ResearchOrange, California
- Mountain View Clinical ResearchDenver, Colorado
- The Medici Medical ResearchHollywood, Florida
- Sandhill Research, LLC/DBA Accel Research SitesLargo, Florida