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New drug candidate for stubborn depression tested, but study halted early

NCT ID NCT04663321

Symptom relief Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether MK-1942, when added to standard antidepressants, could help people with treatment-resistant depression. About 99 participants were planned, but the trial was terminated early. The goal was to measure changes in depression scores and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MK-1942
What this could lead to
If successful, MK-1942 could offer a new option for people with depression that doesn't respond to standard antidepressants.
What could go wrong
This was an early-phase trial that was terminated, so results are limited. It's unclear if MK-1942 is effective or safe long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

99 people

The number who actually took part.

Started

May 2021

Finished

Sep 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Meets 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) * Is currently experiencing an episode of moderate-to-severe MDD * Had an inadequate response to 1 to 4 different courses of antidepressant therapy for the current episode of moderate-to-severe MDD * Has been on a stable course of antidepressant therapy for ≥4 weeks before Visit 1 (Screening) * Has not initiated psychotherapy for depressive symptoms in the last 3 months before Visit 1 (Screening) and agrees not to initiate a new psychotherapy for depressive symptoms or to modify their current regimen of psychotherapy for depressive symptoms from Visit 1 (Screening) to Visit 9 (Post-dose Follow-up Visit) * Male participants are eligible if they agree to the following during the intervention period and for at least 7 days after last dose of study intervention: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent or agrees to use contraception unless confirmed to be azoospermic (vasectomized or secondary to medical cause) * A female participant is eligible to participate if she is not a woman of childbearing potential (WOCBP) or a WOCBP who is not pregnant, breastfeeding, or within 3 months from postpartum. WOCBP should use contraceptive methods that are highly effective as per the study specifications or be abstinent from heterosexual intercourse as their preferred and usual lifestyle, have a negative pregnancy test at screening, immediately prior to the first dosing event, and at regular intervals during the study period, and abstain from breastfeeding during the study intervention period and for at least 7 days after last study intervention * Has a reliable contact person Exclusion Criteria: * Has an ongoing episode of MDD that started more than 2 years before Visit 1 (Screening) * Has a current or prior history of one or more of the following: a) diagnosis of a psychotic disorder b) chronic convulsive disorder, except febrile seizures during childhood c) neurodegenerative disorder, traumatic brain injury causing ongoing cognitive difficulties, or any chronic organic disease of the central nervous system d) intellectual disability of a severity that would affect the ability of the participant to participate in the study e) bipolar and related disorders, MDD with psychosis f) MDD with mixed features g) posttraumatic stress disorder if not in remission for at least 5 years before Visit 1 (Screening) h) obsessive-compulsive disorder i) autism spectrum disorder * Meets criteria for substance abuse or dependence disorder currently or within the 12 months before Visit 1 (Screening) * Has a known allergy or intolerance to the active or inert ingredients in MK-1942 * Has a history of malignancy ≤3 years before Visit 1 (Screening) except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * Has a Body Mass Index (BMI) \>40 kg/m2 * Has HIV or nonstable hypothyroidism, diabetes, cardiovascular disease, or respiratory disease * Failed to adequately respond to treatment with ketamine or esketamine for the current or a prior episode of MDD * Previously received electroconvulsive therapy within the past 10 years, deep brain stimulation, or vagal nerve stimulation for treatment of depression * Is imminent risk for self harm or harm to others * Is currently participating in or has previously participated in an interventional clinical study within the 2 months before Visit 1 (Screening), or has participated in \>4 interventional clinical studies within the 2 years before Visit 1 (Screening) * Has known renal disease or is experiencing renal insufficiency * Routinely consumes \>3 alcoholic drinks per day. One standard drink is defined as any beverage containing 14 gram (g) of pure alcohol * Requires use of a language interpreter to participate in the study * Had major surgery or donated or lost \>1 unit of blood within the 4 weeks before Visit 1 (Screening) * Is pregnant or is currently breastfeeding or plans to breastfeed during the course of the study * Is a woman with \<12 months of amenorrhea and is receiving hormone replacement therapy (HRT) or an estrogen-based contraceptive * Is or has an immediate family member who is investigational site or Sponsor staff directly involved with this study

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Treatment-resistant depression

Contacts and locations

Locations

  • AIM Trials, LLC ( Site 1111)

    Plano, Texas, 75093, United States

  • APG RESEARCH, LLC ( Site 1087)

    Orlando, Florida, 32803, United States

  • Albuquerque Neuroscience Inc. ( Site 1107)

    Albuquerque, New Mexico, 87109, United States

  • Altea Research ( Site 1018)

    Las Vegas, Nevada, 89102, United States

  • Aqualane Clinical Research ( Site 1113)

    Naples, Florida, 34105, United States

  • Ascension Saint Elizabeth ( Site 1003)

    Chicago, Illinois, 60622, United States

  • Atlanta Center for Medical Research ( Site 1022)

    Atlanta, Georgia, 30331, United States

  • Axiom Research ( Site 1053)

    Colton, California, 92324, United States

  • Baylor College of Medicine ( Site 1019)

    Houston, Texas, 77030, United States

  • Behavioral Clinical Research ( Site 1037)

    Miami, Florida, 33016, United States

  • Boston Clinical Trials ( Site 1028)

    Boston, Massachusetts, 02131, United States

  • CBH Health ( Site 1076)

    Gaithersburg, Maryland, 20877, United States

  • CITrials ( Site 1105)

    Santa Ana, California, 92705, United States

  • CITrials-Outpatient Facility ( Site 1098)

    Bellflower, California, 90706, United States

  • Cedar Clinical Research ( Site 1023)

    Draper, Utah, 84020, United States

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare ( Site 1039)

    Jacksonville, Florida, 32256, United States

  • Clinical Trials of America, LLC ( Site 1103)

    Hickory, North Carolina, 28601, United States

  • Collaborative Neuroscience Network, LLC. ( Site 1032)

    Garden Grove, California, 92845, United States

  • Core Clinical Research ( Site 1081)

    Everett, Washington, 98201, United States

  • Global Medical Institutes LLC; Princeton Medical Institute ( Site 1049)

    Princeton, New Jersey, 08540, United States

  • Gulfcoast Clinical Research Center ( Site 1110)

    Fort Myers, Florida, 33912, United States

  • Hapworth Research Inc.-Clinical Research Department ( Site 1090)

    New York, New York, 10022, United States

  • Hassman Research Institute ( Site 1036)

    Berlin, New Jersey, 08009, United States

  • Innovative Clinical Research ( Site 1044)

    Lauderhill, Florida, 33319, United States

  • Institute of Living ( Site 1061)

    Hartford, Connecticut, 06106, United States

  • K2 Medical Research - Winter Park ( Site 1115)

    Winter Park, Florida, 32792, United States

  • Keystone Clinical Studies ( Site 1031)

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Manhattan Behavioral Medicine ( Site 1096)

    New York, New York, 10036, United States

  • Neuro-Behavioral Clinical Research ( Site 1045)

    North Canton, Ohio, 44720, United States

  • New Hope Clinical Research ( Site 1082)

    Charlotte, North Carolina, 28211, United States

  • Northwest Clinical Research Center ( Site 1112)

    Bellevue, Washington, 98007, United States

  • Paradigm Research Professionals ( Site 1089)

    Oklahoma City, Oklahoma, 73118, United States

  • Penn Medicine: University of Pennsylvania Health System-Mood Disorders Treatment and Research Proga

    Philadelphia, Pennsylvania, 19104, United States

  • Preferred Research Partners ( Site 1079)

    Little Rock, Arkansas, 72211, United States

  • Psych Atlanta ( Site 1108)

    Marietta, Georgia, 30060, United States

  • Richmond Behavioral Associates ( Site 1011)

    Staten Island, New York, 10314, United States

  • Suburban Research Associates-Clinical Research ( Site 1042)

    Media, Pennsylvania, 19063, United States

  • University of Alabama at Birmingham - School of Medicine-Psychiatry ( Site 1073)

    Birmingham, Alabama, 35233, United States

  • University of Michigan-Psychiatry ( Site 1051)

    Ann Arbor, Michigan, 48026, United States

  • University of South Florida-Psychiatry and Behavioral Neurosciences ( Site 1093)

    Tampa, Florida, 33613, United States

  • Velocity Clinical Research, Hallandale Beach ( Site 1116)

    Hallandale, Florida, 33009, United States

  • Woodland International Research Group ( Site 1017)

    Little Rock, Arkansas, 72211, United States

  • Woodstock Research Center ( Site 1084)

    Woodstock, Vermont, 05091, United States

  • iResearch Atlanta ( Site 1040)

    Decatur, Georgia, 30030, United States

  • iResearch Savannah ( Site 1041)

    Savannah, Georgia, 31405, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.