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ACP-211

Phase 2

Major Depressive Disorder (MDD) | Small molecule | Psychiatry |ACADIA Pharmaceuticals Inc.|Last Updated: Jul 16, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment153
FDA Designations
No designations recorded
Clinical trial landscape

ACP-211 · 1 trial · 2 indications

Phase 2 1
NCT07284667ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant ResponseMajor Depressive Disorder (MDD)
RECRUITING153 Analytics
PHASE2RECRUITING
ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
Major Depressive Disorder (MDD)Unlock trial analytics
Study Endpoints
Primary Endpoints
Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28
Baseline and 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.

Secondary Endpoints
Change From Baseline in MADRS Total Score at Day 2
Baseline and Day 2 (24 hours postdose)
Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits
Baseline through Day 28
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits
Baseline through Day 28
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ACP-211 600 mgEXPERIMENTALACP-211 600 mg, administered orally twice weekly
ACP-211 300 mgEXPERIMENTALACP-211 300 mg, administered orally twice weekly
PlaceboPLACEBO_COMPARATORMatching placebo, administered orally twice weekly
Interventions
NameTypeDescription
ACP-211DRUGACP-211 monotherapy
PlaceboDRUGPlacebo control
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Eligibility Criteria
Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites23

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 an...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJul 17, 2026NCT07284667lastUpdatePostDate: changed
LOWJul 17, 2026NCT07284667lastUpdatePostDate: changed
LOWJul 17, 2026NCT07284667lastUpdatePostDate: changed
LOWJul 13, 2026NCT07284667lastUpdatePostDate: changed
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LOWJun 8, 2026NCT07284667lastUpdatePostDate: changed
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LOWJun 8, 2026NCT07284667lastUpdatePostDate: changed
LOWMay 26, 2026NCT07284667primaryCompletionDate: changed
LOWMay 24, 2026NCT07284667studyFirstPostDate: changed