ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorACADIA Pharmaceuticals Inc.
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ACP-211
- Placebo
Treatment groups
153 Participants
are divided into 3 treatment groupsLocations
23Alabama
University of Alabama at Birmingham35294, Birmingham United States
California
Inland Psychiatric Medical Group91710, Chino United States
Behavioral Research Specialists, LLC91107, Glendale United States
Kadima Neuropsychiatry Institute92037, La Jolla United States
Sponsors and collaborators
ACADIA Pharmaceuticals Inc.
Lead sponsor
Source ClinicalTrials.gov