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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing ACP-211 for Major Depressive Disorder (MDD)

The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (major depression) 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 dummy treatment (placebo) (a look-alike capsule with no medicine) to reduce symptoms of depression?

Official registry: https://clinicaltrials.gov/study/NCT07284667 · ACADIA Pharmaceuticals Inc. · enrollment listed as 153

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are ACP-211, or Placebo. The registry lists allocation as randomized. The goal of this clinical trial is to learn if ACP-211 can help treat adults with major depressive disorder (major depression) who have not improved with antidepressant therapy (ADT), including those with treatment resistant depression (TRD).

They plan to enroll about 153 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: ACP-211, Placebo

Primary outcome (registry wording): Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28

Who it is for (from inclusion criteria)

  • Ages 18 Years to 65 Years
  • Adults ≥18 and ≤65 years of age
  • Clinical diagnosis of major depression
  • 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 antidepressant at a stable dose prior to Screening
  • MADRS total score ≥28, CGI-S score ≥4, and QIDS-SR16 score ≥14 at Screening and Baseline
  • Females of childbearing potential must have a negative pregnancy test and agree to use acceptable contraception; males must agree to use barrier protection and refrain from sperm donation

Public study contact (from the registry)

Sandy Filosi

+1(609) 250-6920

sfilosi@ACADIA-Pharm.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

28 listed

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FAQ about this NCT record

Is NCT07284667 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07284667?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07284667?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary