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RecruitingPhase 2

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ACP-211 alone for adults with major depression who have not improved enough with antidepressants. It compares ACP-211 with a placebo (a look-alike capsule with no medicine) and checks for side effects. Other rules also apply, and the study team will check who can join.

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?

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 65 years old.
  • Sign a form agreeing to join the study.
  • Have a diagnosis of major depression.
  • Have tried at least two antidepressants without enough improvement, with at least one such result recorded during the current period of depression.
  • Be taking an approved antidepressant at a steady dose before screening.
  • Meet these depression rating scores at screening and the starting visit: MADRS 28 or higher, CGI-S 4 or higher, and QIDS-SR16 16 or higher.
  • Women who can become pregnant must have a negative pregnancy test and agree to use acceptable birth control.
  • Men must agree to use barrier protection, such as condoms, and not donate sperm.

Who can't join

  • Have certain personality disorders or ongoing, long-term depression; or have a history of schizophrenia, other disorders involving loss of touch with reality, bipolar disorder, or depression with these symptoms.
  • Need treatment now for PTSD (stress after trauma), acute stress disorder, panic disorder, or OCD (unwanted thoughts and repeated actions); or have recently started or changed talk therapy.
  • Have a recent substance use disorder, except caffeine or nicotine, or a positive urine test for an illegal drug or cannabis.
  • Be at active risk of suicide or have recently attempted suicide.
  • Have a history of neuroleptic malignant syndrome or serotonin syndrome (serious medicine reactions), or epilepsy (a seizure disorder), except one fever-related seizure in infancy.
  • Have an allergy or sensitivity to ketamine or esketamine.
  • Have serious heart or blood vessel disease, a history of hepatitis B, hepatitis C, or HIV infection, unstable diabetes, or another uncontrolled health condition.
  • Have received brain or nerve stimulation treatments—ECT, TMS, VNS, or DBS—during the current period of depression.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (28)

AL

CA

CO

FL

MA

MO

MS

NC

NE

NJ

NV

NY

OH

TX

UT