Major Depressive Disorder study: ACP-211
Official title ACP-211 Monotherapy for Major Depressive Disorder With Inadequate Antidepressant Response
ClinicalTrials.gov ID: NCT07284667
What this study is testing
What is ACP-211?
ACP-211 is an investigational medicine being studied to see if it can help treat major depressive disorder.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether ACP-211 works better than a pretend pill to reduce depression symptoms. It also looks at how safe the medicine is and what side effects it causes.
- Who it's for
- You may be able to join if you are an adult with major depression that has not improved with other antidepressant treatments.
- What's involved
- You would take a pill every day. You would also have check-ins to see how you are feeling and to report any side effects.
- Time commitment
- The study lasts for a set time, and you will need to come in for regular visits.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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
You likely can't join if
- 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)
See the full eligibility 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 ≥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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Chino, California, United States
- Glendale, California, United States
- La Jolla, California, United States
- Orange, California, United States
- West Hills, California, United States
- Denver, Colorado, United States
- Fort Myers, Florida, United States
- Hollywood, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Watertown, Massachusetts, United States
- Worcester, Massachusetts, United States
- Flowood, Mississippi, United States
- Saint Charles, Missouri, United States
- Lincoln, Nebraska, United States
- Las Vegas, Nevada, United States
- Brooklyn, New York, United States
- Cary, North Carolina, United States
- North Canton, Ohio, United States
+ 4 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chino, California, United States; Glendale, California, United States; La Jolla, California, United States; Orange, California, United States; West Hills, California, United States; Denver, Colorado, United States and 18 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.