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Recruiting NCT07284667

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

Phase II Interventional Major Depressive Disorder (MDD) Depressive Disorder, Treatment-Resistant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ACP-211, Placebo.
Who it may be relevant to
Registry conditions: Major Depressive Disorder (MDD), Depressive Disorder, Treatment-Resistant. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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?

Interventions

  • Drug ACP-211
    ACP-211 monotherapy
  • Drug Placebo
    Placebo control

Primary outcome measures

  • Change From Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Day 28 [Time frame: Baseline and Day 28]
Secondary outcome measures (7)
  • Change From Baseline in MADRS Total Score at Day 2 [Time frame: Baseline and Day 2 (24 hours postdose)]
  • Change From Baseline in MADRS Total Score at Scheduled Postbaseline Visits [Time frame: Baseline through Day 28]
  • Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Scheduled Postbaseline Visits [Time frame: Baseline through Day 28]
  • Proportion of Subjects in Remission at Scheduled Postbaseline Visits (MADRS ≤10) [Time frame: Up to Day 28]
  • Proportion of Subjects With Response at Scheduled Postbaseline Visits (≥50% Reduction From Baseline in MADRS Total Score) [Time frame: Up to Day 28]
  • Proportion of Subjects With Sustained Response From Day 2 Through Day 28 [Time frame: Day 2 through Day 28]
  • Proportion of Subjects With Clinical Global Impression of Improvement (CGI-I) Score of 1 or 2 at Scheduled Postbaseline Visits [Time frame: Up to Day 28]

Eligibility criteria

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 antidepressant at a stable dose prior to Screening
  • MADRS total score ≥28, CGI-S score ≥4 , and QIDS-SR16 score ≥16 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

Exclusion criteria

  • Current diagnosis of certain personality disorders or persistent depressive disorder
  • Recent substance use disorders, excluding caffeine or nicotine
  • Active suicidal risk or recent suicidal attempt
  • History of schizophrenia, psychotic disorders, bipolar disorder, or MDD with psychotic features
  • Current treatment requirement for PTSD, acute stress disorder, panic disorder, or OCD
  • History of neuroleptic malignant syndrome, serotonin syndrome, or epilepsy (except single febrile seizure in infancy)
  • Allergy or sensitivity to ketamine or esketamine
  • Significant cardiovascular disease
  • Positive history of hepatitis B, hepatitis C, or HIV infection
  • Unstable diabetes or uncontrolled medical conditions
  • Positive urine drug test for an illicit drug or cannabis
  • Received neuromodulation therapies (ECT, TMS, VNS, DBS) in the current depressive episode
  • Recent initiation or change in psychotherapy

Additional inclusion/exclusion criteria apply. Participants will be evaluated at Screening to ensure that all criteria for study participation are met.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 26 centers
  • University of Alabama at Birmingham — Birmingham
  • Inland Psychiatric Medical Group — Chino
  • Behavioral Research Specialists, LLC — Glendale
  • Kadima Neuropsychiatry Institute — La Jolla
  • PNS Clinical Research LLC dba ATP Clinical Research — Orange
  • Mountain View Clinical Research — Denver
  • New Access Research and Medical Services, Inc. — Fort Myers
  • The Medici Medical Research — Hollywood
  • … and 18 more centers

Identifiers

NCT: NCT07284667 · ACP-211-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗