MK-1942 for Depression
Phase-Based Progress Estimates
Effectiveness
Safety
Depression+3 More
MK-1942 - DrugEligibility
18+
All Sexes
What conditions do you have?
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Eligibility
18+
All Sexes
What conditions do you have?
Select
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
- Depression
- Unipolar Depression
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 5 Secondary · Reporting Duration: Week 0 (Day 1): Predose and 1-hour postdose and Weeks 1, 2, 3 & 4: Predose
Baseline, Week 1
Change From Baseline in MADRS Total Score to Week 1
Change From Baseline in the CGI-S Total Score to Week 1
Change From Baseline in the HAM-D17 Scale Total Score to Week 1
Baseline, Week 3
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 3
Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 3
Change From Baseline in the Hamilton Depression Rating Scale (HAM-D17) Total Score to Week 3
Week 4
Number of Participants Who Discontinued Study Treatment Due to an AE
Week 6
Number of Participants Who Experienced An Adverse Event (AE)
Week 1
Mean Plasma Concentration of MK-1942 plasma concentration
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
3 Treatment Groups
MK-1942 Intermittent Dose Group
1 of 3
MK-1942 Daily Dose Group
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
140 Total Participants · 3 Treatment Groups
Primary Treatment: MK-1942 · Has Placebo Group · Phase 2
MK-1942 Intermittent Dose GroupExperimental Group · 2 Interventions: MK-1942, Placebo · Intervention Types: Drug, Drug
MK-1942 Daily Dose GroupExperimental Group · 2 Interventions: MK-1942, Placebo · Intervention Types: Drug, Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: DrugTreatment
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
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 0 (day 1): predose and 1-hour postdose and weeks 1, 2, 3 & 4: predose
Who is running the clinical trial?
Merck Sharp & Dohme Corp.Lead Sponsor
2,286 Previous Clinical Trials
4,579,064 Total Patients Enrolled
13 Trials studying Depression
5,633 Patients Enrolled for Depression
Merck Sharp & Dohme LLCLead Sponsor
3,653 Previous Clinical Trials
4,953,467 Total Patients Enrolled
17 Trials studying Depression
7,748 Patients Enrolled for Depression
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,618 Previous Clinical Trials
7,936,685 Total Patients Enrolled
10 Trials studying Depression
923 Patients Enrolled for Depression
Eligibility Criteria
Age 18+ · All Participants · 8 Total Inclusion Criteria
Mark “yes” if the following statements are true for you: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 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 been on a stable course of antidepressant therapy for ≥4 weeks before Visit 1 (Screening).
You are currently experiencing an episode of moderate-to-severe MDD.
You have a reliable contact person.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| New Jersey | 16.7% |
| Maryland | 16.7% |
| Georgia | 8.3% |
| Other | 58.3% |
How old are they?
| 18 - 65 | 81.8% |
| 65+ | 18.2% |
What site did they apply to?
| Altea Research ( Site 1018) | 22.2% |
| Global Medical Institutes LLC; Princeton Medical Institute ( Site 1049) | 11.1% |
| Penn Medicine: University of Pennsylvania Health System-Mood Disorders Treatment and Research Proga | 11.1% |
| Other | 55.6% |
What portion of applicants met pre-screening criteria?
| Met criteria | 81.8% |
| Did not meet criteria | 18.2% |
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