NCT07284667

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

A Double-Blind, Placebo-Controlled, Parallel Group, Efficacy and Safety Study of ACP-211 Monotherapy in Adults With Major Depressive Disorder and Inadequate Response to Antidepressant Treatment

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (estimated)
• Sponsor: ACADIA Pharmaceuticals Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	ACP-211	ACP-211 monotherapy
DRUG	Placebo	Placebo control

Timeline

• Start date: 2025-11-14
• Primary completion: 2027-08-01
• Completion: 2027-09-01
• First posted: 2025-12-16
• Last updated: 2026-04-17

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study