MK-1942 for Depression

No longer recruiting at 47 trial locations

Overseen By Toll Free Number

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Merck Sharp & Dohme Corp.

Must be taking: Antidepressants

Must not be taking: Ketamine, Esketamine

Disqualifiers: Psychotic disorder, Bipolar, Substance abuse, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new medication, MK-1942, to determine its effectiveness and safety for individuals with Treatment-Resistant Depression (TRD) who are already on stable antidepressant therapy. The trial compares two dosing schedules of MK-1942—daily and intermittent—against a placebo (a harmless pill with no active medicine). Suitable candidates are those experiencing moderate-to-severe depression despite trying at least one but no more than four antidepressants and have maintained steady antidepressant treatment for at least four weeks. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in depression treatment.

Will I have to stop taking my current medications?

The trial requires participants to be on a stable course of antidepressant therapy for at least 4 weeks before joining, so you will not need to stop your current antidepressant medications.

Is there any evidence suggesting that MK-1942 is likely to be safe for humans?

A previous study found that MK-1942 is generally well-tolerated. Participants reported mild side effects, such as headaches and nausea, which are common with many medications. Importantly, the study reported no serious side effects, suggesting that MK-1942 is safe for short-term use. As this trial is in an early phase, further research is needed to confirm its long-term safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about MK-1942 because it offers a novel approach to treating treatment-resistant depression (TRD), a condition where traditional antidepressants like SSRIs and SNRIs often fall short. Unlike these common treatments, which primarily focus on altering serotonin or norepinephrine levels, MK-1942 targets different pathways in the brain, potentially offering relief to patients who haven't responded to existing options. Additionally, MK-1942 is being tested in both daily and intermittent dosing schedules, providing potential flexibility in how it's administered. This could make it a game-changer for those struggling with TRD, offering hope for faster and potentially more effective results.

What evidence suggests that this trial's treatments could be effective for Treatment-Resistant Depression?

This trial will compare different dosing regimens of MK-1942 with a placebo. Research has shown that MK-1942 may benefit people with Alzheimer's disease. Earlier studies tested its effectiveness alongside other treatments. While these studies primarily focused on Alzheimer's, they suggest that MK-1942 might also aid other brain conditions. It targets specific pathways in the brain, potentially improving mood and cognitive skills. Although limited data exists on its effectiveness for treatment-resistant depression, these early findings offer hope for success in this new area. ^{6 7 8 9 10}

Who Is on the Research Team?

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

Inclusion Criteria

You are currently going through a period of moderate to severe depression.

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.

Has a reliable contact person

Exclusion Criteria

You have struggled with substance abuse or addiction in the past year or currently.

You have HIV or unstable conditions like hypothyroidism, diabetes, heart problems, or lung problems.

You are allergic to any of the ingredients in the medication MK-1942.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive MK-1942 or placebo for 4 weeks, with daily or intermittent dosing

4 weeks

Weekly visits for monitoring and dose adjustments

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• MK-1942
• Placebo

How Is the Trial Designed?

Group I: MK-1942 Intermittent Dose Group Experimental Treatment 2 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 Group Experimental Treatment 2 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: Placebo Placebo Group 1 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.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme Corp.

Lead Sponsor

Trials

2,287

Recruited

4,582,000+

Chirfi Guindo

Merck Sharp & Dohme Corp.

Chief Medical Officer

Engineering degree from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme Corp.

Chief Executive Officer since 2021

J.D. from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

In a study involving 24 rabbits undergoing spine fusion, daily subcutaneous injections of abaloparatide resulted in a 100% fusion rate compared to only 45% in the control group, indicating its strong efficacy in promoting spinal fusion.

Radiographic analysis showed that abaloparatide significantly increased bone formation and quality, with higher bone volume and improved trabecular structure, suggesting it enhances the biological processes necessary for successful spinal fusion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Abaloparatide Enhances Fusion and Bone Formation in a Rabbit Spinal Arthrodesis Model. Morse, KW., Moore, H., Kumagai, H., et al.[2023]

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

MK-8389 was found to be generally safe and well tolerated in healthy young women over a 14-day period, although it caused transient changes in thyroid function tests that limited dose escalation above 40 mg.

While MK-8389 showed acceptable systemic exposure, it did not have a clinically meaningful effect on follicular development, although higher doses did increase inhibin B levels, indicating some early follicular activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral follicle-stimulating hormone agonist tested in healthy young women of reproductive age failed to demonstrate effect on follicular development but affected thyroid function. Gerrits, MG., Kramer, H., el Galta, R., et al.[2016]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05602727?tab=results

Study Results | Efficacy and Safety of MK-1942 as an Adjunct ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05602727

Efficacy and Safety of MK-1942 as an Adjunct Therapy in ... The main purpose of this study was to assess the safety and efficacy of MK-1942 as adjunctive therapy in participants with mild to moderate Alzheimer's Disease ...

3. clinicaltrials.eu clinicaltrials.eu/inn/mk-1942/

MK-1942: A Promising New Drug for Alzheimer's Disease ... MK-1942 is still in the early stages of clinical development, but it shows promise for potentially helping patients with Alzheimer's disease and treatment- ...

4. ctv.veeva.com ctv.veeva.com/study/efficacy-and-safety-of-mk-1942-as-an-adjunct-therapy-in-participants-with-mild-to-moderate-alzheimer

Efficacy and Safety of MK-1942 as an Adjunct Therapy in ... The main purpose of this study was to assess the safety and efficacy of MK-1942 as adjunctive therapy in participants with mild to moderate ...

5. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2021-006336-94/IT

Clinical Trials Register To assess the efficacy of MK-1942 at 5 mg and 15 mg bid as adjunctive therapy on the ADAS-Cog11 score compared with placebo at Week 12. 2 ...

6. fishersci.com fishersci.com/store/msds?partNumber=AA12363A3&productDescription=ammonium-nitrate-acs--min-thermo-scientifictrade&vendorId=VN00024248&keyword=true&countryCode=US&language=en

SAFETY DATA SHEET Precautionary Statements. Prevention. Keep/Store away from clothing/ other combustible materials. Take any precaution to avoid mixing with ...

7. sigmaaldrich.com sigmaaldrich.com/sds/sigald/221244?srsltid=AfmBOorFnpPmiDbZc8oH1zoiQa40WB6d7E492fLH6qv1kECs_d2BmTan

SAFETY DATA SHEET Handle uncleaned containers like the product itself. SECTION 14: Transport information. DOT (US). UN number: 1942 Class: 5.1. Packing group: III.

8. assets.greenbook.net assets.greenbook.net/M106135.pdf

Material Safety Data Sheet - Greenbook.net Ingestion: No hazard in normal industrial use. Ingestion of large amount may cause systemic ammonia poisoning and nitrate poisoning. Inhalation:.

9. spectrumchemical.com spectrumchemical.com/MSDS/A1215_AGHS.pdf?srsltid=AfmBOor6UEaogATFG0i7GZtXJDB41wBmbR2bs78NeEuZw5s2iloj5yjy

SAFETY DATA SHEET Runoff may create fire or explosion hazard. Explosion data. Sensitivity to mechanical impact none. Sensitivity to static discharge yes. Special ...

10. products.nutrien.com products.nutrien.com/docs/578

Ammonium Nitrate Solution, 83-86% Prevention. : Keep away from heat, hot surfaces, sparks, open flames and other ignition sources. No smoking. Take any precaution to avoid ...