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MK-1942 for Major Depressive Disorder
Study Summary
This trial is testing whether the study drug, MK-1942, is better than placebo at reducing depression scores for people who haven't responded to other antidepressants.
- Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have struggled with substance abuse or addiction in the past year or currently.You are currently going through a period of moderate to severe depression (MDD).You have HIV or unstable conditions like hypothyroidism, diabetes, heart problems, or lung problems.You are currently going through a period of moderate to severe depression.You are allergic to any of the ingredients in the medication MK-1942.You have tried 1 to 4 different antidepressant medications for your current episode of moderate-to-severe depression, but they did not work well enough for you.You have been experiencing depression for more than 2 years without any significant improvement.You meet the diagnostic criteria for moderate-to-severe major depressive disorder (MDD) without psychotic features according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria at Visit 1 (Screening).You have not had electroconvulsive therapy, deep brain stimulation, or vagal nerve stimulation for treating depression in the past 10 years.You have tried different antidepressant medications, but they didn't work well enough to treat your moderate-to-severe depression.You have been on a stable course of antidepressant therapy for ≥4 weeks before Visit 1 (Screening).You are currently going through a period of moderate-to-severe depression.You are a female and at least one of the following conditions apply: You are not pregnant or breastfeeding, and you are aged 18 years or older.You have a reliable contact person.You didn't get better after trying ketamine or esketamine for your depression in the past.You are currently at a high risk of hurting yourself or others.You drink more than 3 alcoholic drinks every day. A standard drink is a beverage that contains 14 grams of pure alcohol.
- Group 1: MK-1942 Daily Dose Group
- Group 2: MK-1942 Intermittent Dose Group
- Group 3: Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What adverse effects have been linked to MK-1942 use?
"Given the Phase 2 status of MK-1942, our team has assessed its safety as a score of two due to some data being available in regards to safety yet none for efficacy."
How many participants has this clinical trial enrolled thus far?
"According to Merck Sharp & Dohme Corp., the sponsoring organisation of this medical trial, a total 140 compliant participants must be enrolled for it to start. These can come from Ascension Saint Elizabeth (Site 1003) in Chicago or Richmond Behavioral Associates( Site 1011) on Staten Island."
Are there still open slots for participants in this experiment?
"Absolutely. According to clinicaltrials.gov, this medical research endeavour began on May 20th 2021 and will accept applicants until October 28th 2022. 140 volunteers are needed for the trial at 36 different sites across the nation."
What are the overarching goals of this research endeavor?
"Merck Sharp & Dohme Corp., the trial sponsor, has identified two main objectives to be measured during this clinical study. The primary outcome is Number of Participants Who Discontinued Study Treatment Due to an AE over a Baseline, Week 1 timeline. Secondary outcomes include Change From Baseline in Clinician Global Impression-Severity (CGI-S) Total Score to Week 3 and Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) total score at both Weeks 1 and 3. CGI-S uses a 7 point scale with higher numbers representing greater symptom severity while HAM-D17 assigns scores"
What is the eligibility criteria for enrollment in this research?
"This medical trial is seeking 140 individuals, aged 18 to 65 and struggling with depression. To be eligible for enrollment, participants must meet the DSM-5 criteria of major depressive disorder and have had an inadequate response to antidepressant therapy in the past four weeks. Furthermore, male patients are required to remain abstinent or use contraception while female participants cannot currently be pregnant nor breastfeeding. Additionally, all enrollees should maintain contact with a reliable person throughout their participation in the study."
Are aged-based restrictions in place for enrollment into this research?
"The eligibility criteria for this trial encompasses adults aged 18-65."
How many sites are engaged in this experiment?
"At this time, 36 medical centres across the nation are participating in the trial. Locations span from Chicago to Staten Island and Charlotte, as well as many other places. Therefore, it is best to pick a nearby site which will reduce your travelling burden if you choose to take part."
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