← Back to Search

MK-1942 for Major Depressive Disorder

Phase 2
Waitlist Available
Research Sponsored by Merck Sharp & Dohme Corp.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Had an inadequate response to 1 to 4 different courses of antidepressant therapy for the current episode of moderate-to-severe MDD
Is currently experiencing an episode of moderate-to-severe MDD
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 (day 1): predose and 1-hour postdose and weeks 1, 2, 3 & 4: predose
Awards & highlights

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.

Eligible Conditions
  • Major Depressive Disorder

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have tried different antidepressant medications, but they didn't work well enough to treat your moderate-to-severe depression.
Select...
You are currently going through a period of moderate-to-severe depression.
Select...
You are currently going through a period of moderate to severe depression.
Select...
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 (day 1): predose and 1-hour postdose and weeks 1, 2, 3 & 4: predose
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (day 1): predose and 1-hour postdose and weeks 1, 2, 3 & 4: predose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline in MADRS Total Score to Week 1
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 3
Number of Participants Who Discontinued Study Treatment Due to an AE
+1 more
Secondary outcome measures
Change From Baseline in the CGI-S Total Score to Week 1
Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 3
Change From Baseline in the HAM-D17 Scale Total Score to Week 1
+2 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: MK-1942 Intermittent Dose GroupExperimental Treatment2 Interventions
Participants receive a total daily dose of 10 mg of MK-1942 twice weekly (BIW), orally, for Weeks 1-4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Group II: MK-1942 Daily Dose GroupExperimental Treatment2 Interventions
Participants receive a total daily dose titrated from 5 mg to 20 mg of MK-1942 twice daily (BID), orally, over 4 weeks of treatment duration: 5 mg in Week 1, 10 mg in Week 2, and 20 mg in Weeks 3 and 4. Participants receive MK-1942 and matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Group III: PlaceboPlacebo Group1 Intervention
Participants receive a dose-matched placebo BID, orally, for 4 weeks. Participants receive matching placebo packaged in blister cards with an equal number of capsules administered in the morning and evening regardless of treatment assignment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MK-1942
2021
Completed Phase 1
~30
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,581,812 Total Patients Enrolled
Merck Sharp & Dohme LLCLead Sponsor
3,862 Previous Clinical Trials
5,049,601 Total Patients Enrolled
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,769 Previous Clinical Trials
8,062,101 Total Patients Enrolled

Media Library

MK-1942 Clinical Trial Eligibility Overview. Trial Name: NCT04663321 — Phase 2
Major Depressive Disorder Research Study Groups: MK-1942 Daily Dose Group, MK-1942 Intermittent Dose Group, Placebo
Major Depressive Disorder Clinical Trial 2023: MK-1942 Highlights & Side Effects. Trial Name: NCT04663321 — Phase 2
MK-1942 2023 Treatment Timeline for Medical Study. Trial Name: NCT04663321 — Phase 2
Major Depressive Disorder Patient Testimony for trial: Trial Name: NCT04663321 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

Are aged-based restrictions in place for enrollment into this research?

"The eligibility criteria for this trial encompasses adults aged 18-65."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Georgia
Pennsylvania
Other
How old are they?
65+
18 - 65
What site did they apply to?
iResearch Savannah ( Site 1041)
Altea Research ( Site 1018)
Global Medical Institutes LLC; Princeton Medical Institute ( Site 1049)
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
0
3+

What questions have other patients asked about this trial?

Is there compensation? When does it start?
PatientReceived 1 prior treatment

Why did patients apply to this trial?

Need to try something different and willing to travel. I've tried many drugs over the years, as well as TMS and ECT. Nothing is helping.
PatientReceived 2+ prior treatments
I've been through so many medications and doctors and I have ALWAYS still been depressed.
PatientReceived no prior treatments
I would like to see if this drug will make my major depressive disorder symptoms better. So I can be more productive to society and take care of my family better.
PatientReceived 1 prior treatment
~26 spots leftby Mar 2025