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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
ACP-211
DrugACP-211 monotherapy
Placebo
DrugPlacebo control
Treatment groups
153 Participants
are divided into 3 treatment groupsGroup A: ACP-211 600 mgExperimental treatment 1 intervention
Group B: ACP-211 300 mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity.
Time frame
Baseline and Day 28Secondary outcomes
1
Change From Baseline in MADRS Total Score at Day 2
The MADRS is a clinician-rated scale that assesses the severity of depressive symptoms. It consists of 10 items, each scored from 0 (no symptoms) to 6 (severe symptoms), resulting in a total score range of 0 to 60. Higher scores indicate greater depression severity.
Time frame
Baseline and Day 2 (24 hours postdose)2
Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits
Time frame
Baseline through Day 283
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits
The CGI-S is a clinician-rated assessment of illness severity scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill). Higher scores indicate greater illness severity.
Time frame
Baseline through Day 284
Proportion of Subjects in Remission at Scheduled Postbaseline Visits (MADRS ≤10)
Time frame
Up to Day 28Sponsors and contacts
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Source ClinicalTrials.gov