ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
ACADIA Pharmaceuticals Inc.
Study ID
NCT07284667
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Depressive Disorder, Treatment-Resistant
  • Major Depressive Disorder (MDD)

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ACP-211 — DRUG
    ACP-211 monotherapy
  • Placebo — DRUG
    Placebo control

Study Details

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?

Key Dates

Start date
Nov 14, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
153 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ACP-211 600 mg
    ACP-211 600 mg, administered orally twice weekly
  • Experimental: ACP-211 300 mg
    ACP-211 300 mg, administered orally twice weekly
  • Placebo Comparator: Placebo
    Matching placebo, administered orally twice weekly

Primary Outcome Measure

Change from Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score at Day 28 [ Time Frame: Baseline and Day 28 ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Inland Psychiatric Medical GroupChinoCalifornia91710-
Kadima Neuropsychiatry InstituteLa JollaCalifornia92037-
PNS Clinical Research LLC dba ATP Clinical ResearchOrangeCalifornia92866-
Mountain View Clinical ResearchDenverColorado80209-
The Medici Medical ResearchHollywoodFlorida33021-
Sandhill Research, LLC/DBA Accel Research SitesLargoFlorida33777-
Clinical Neuroscience Solutions, Inc.OrlandoFlorida32801-
IPTB Clinical ResearchTampaFlorida33629-
Neuroscience Research Institute, Inc.West Palm BeachFlorida33407-
Vitalix Clinical, Inc.WorcesterMassachusetts01608-
St. Charles Psychiatric Associates, Inc. dba Midwest Research GroupSaint CharlesMissouri63304-
Redbird Research LLCLas VegasNevada89134-
CenExel Hassman Research Institute, LLCMarltonNew Jersey08053-
Integrative Clinical Trials LLCBrooklynNew York11229-
Magnolia Clinical Research, LLCCaryNorth Carolina27511-
Neuro-Behavioral Clinical ResearchNorth CantonOhio44720-
Baylor College of MedicineHoustonTexas77030-
Dynamed Clinical Research LP d/b/a DM Clinical ResearchHoustonTexas77081-
Olympus Clinical Research, LLCKatyTexas77450-
Family Psychiatry of The WoodlandsThe WoodlandsTexas77381-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALInland Psychiatric Medical Group· Chino, CAKadima Neuropsychiatry Institute· La Jolla, CAPNS Clinical Research LLC dba ATP Clinical Research· Orange, CAMountain View Clinical Research· Denver, COThe Medici Medical Research· Hollywood, FL

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