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

Detailed criteria

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…

Locations (26)

University of Alabama at Birmingham
Birmingham, Alabama
Inland Psychiatric Medical Group
Chino, California
Behavioral Research Specialists, LLC
Glendale, California
Kadima Neuropsychiatry Institute
La Jolla, California
PNS Clinical Research LLC dba ATP Clinical Research
Orange, California
Mountain View Clinical Research
Denver, Colorado

Summary

Eligibility

Interventions

Locations (26)