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

NCT07284667 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2026-05-08

No results posted yet for this study

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?

Conditions

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

Interventions

DRUG

ACP-211

ACP-211 monotherapy

DRUG

Placebo

Placebo control

Sponsors & Collaborators

  • ACADIA Pharmaceuticals Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2027-08-31
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07284667 on ClinicalTrials.gov