- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04663321
Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006)
September 26, 2023 updated by: Merck Sharp & Dohme LLC
A Phase 2a, Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-1942 Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression
The main purpose of this study is to assess the efficacy and safety of daily and intermittent dosing of MK-1942 compared to placebo among participants with Treatment-Resistant Depression (TRD) on a stable course of antidepressant therapy.
The dual primary hypotheses of the study are that the daily MK-1942 treatment and/or intermittent MK-1942 treatment are superior to placebo in reducing Montgomery-Asberg Depression Rating Scale (MADRS) score.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Toll Free Number
- Phone Number: 1-888-577-8839
- Email: Trialsites@merck.com
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham - School of Medicine-Psychiatry ( Site 1073)
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Arkansas
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Little Rock, Arkansas, United States, 72211
- Preferred Research Partners ( Site 1079)
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Little Rock, Arkansas, United States, 72211
- Woodland International Research Group ( Site 1017)
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California
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Bellflower, California, United States, 90706
- CITrials-Outpatient Facility ( Site 1098)
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Colton, California, United States, 92324
- Axiom Research ( Site 1053)
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Garden Grove, California, United States, 92845
- Collaborative Neuroscience Network, LLC. ( Site 1032)
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Santa Ana, California, United States, 92705
- CITrials ( Site 1105)
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Connecticut
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Hartford, Connecticut, United States, 06106
- Institute of Living ( Site 1061)
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Florida
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Fort Myers, Florida, United States, 33912
- Gulfcoast Clinical Research Center ( Site 1110)
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Hallandale Beach, Florida, United States, 33009
- Velocity Clinical Research, Hallandale Beach ( Site 1116)
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Jacksonville, Florida, United States, 32256
- Clinical Neuroscience Solutions, Inc. dba CNS Healthcare ( Site 1039)
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Lauderhill, Florida, United States, 33319
- Innovative Clinical Research ( Site 1044)
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Miami, Florida, United States, 33016
- Behavioral Clinical Research ( Site 1037)
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Naples, Florida, United States, 34105
- Aqualane Clinical Research ( Site 1113)
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Orlando, Florida, United States, 32803
- APG RESEARCH, LLC ( Site 1087)
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Tampa, Florida, United States, 33613
- University of South Florida-Psychiatry and Behavioral Neurosciences ( Site 1093)
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Winter Park, Florida, United States, 32792
- K2 Medical Research - Winter Park ( Site 1115)
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Georgia
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Atlanta, Georgia, United States, 30331
- Atlanta Center For Medical Research ( Site 1022)
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Decatur, Georgia, United States, 30030
- iResearch Atlanta ( Site 1040)
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Marietta, Georgia, United States, 30060
- Psych Atlanta ( Site 1108)
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Savannah, Georgia, United States, 31405
- iResearch Savannah ( Site 1041)
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Illinois
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Chicago, Illinois, United States, 60622
- Ascension Saint Elizabeth ( Site 1003)
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Maryland
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Gaithersburg, Maryland, United States, 20877
- CBH Health ( Site 1076)
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Massachusetts
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Boston, Massachusetts, United States, 02131
- Boston Clinical Trials ( Site 1028)
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Michigan
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Ann Arbor, Michigan, United States, 48026
- University of Michigan-Psychiatry ( Site 1051)
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Nevada
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Las Vegas, Nevada, United States, 89102
- Altea Research ( Site 1018)
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New Jersey
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Berlin, New Jersey, United States, 08009
- Hassman Research Institute ( Site 1036)
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Princeton, New Jersey, United States, 08540
- Global Medical Institutes LLC; Princeton Medical Institute ( Site 1049)
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Albuquerque Neuroscience Inc. ( Site 1107)
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New York
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New York, New York, United States, 10022
- Hapworth Research Inc.-Clinical Research Department ( Site 1090)
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New York, New York, United States, 10036
- Manhattan Behavioral Medicine ( Site 1096)
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Staten Island, New York, United States, 10314
- Richmond Behavioral Associates ( Site 1011)
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North Carolina
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Charlotte, North Carolina, United States, 28211
- New Hope Clinical Research ( Site 1082)
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Hickory, North Carolina, United States, 28601
- Clinical Trials of America, LLC ( Site 1103)
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Ohio
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North Canton, Ohio, United States, 44720
- Neuro-Behavioral Clinical Research ( Site 1045)
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73118
- Paradigm Research Professionals ( Site 1089)
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Pennsylvania
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Media, Pennsylvania, United States, 19063
- Suburban Research Associates-Clinical Research ( Site 1042)
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Philadelphia, Pennsylvania, United States, 19104
- Penn Medicine: University of Pennsylvania Health System-Mood Disorders Treatment and Research Proga
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Plymouth Meeting, Pennsylvania, United States, 19462
- Keystone Clinical Studies ( Site 1031)
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Texas
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Houston, Texas, United States, 77030
- Baylor College of Medicine ( Site 1019)
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Plano, Texas, United States, 75093
- AIM Trials, LLC ( Site 1111)
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Utah
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Draper, Utah, United States, 84020
- Cedar Clinical Research ( Site 1023)
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Vermont
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Woodstock, Vermont, United States, 05091
- Woodstock Research Center ( Site 1084)
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Washington
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Bellevue, Washington, United States, 98007
- Northwest Clinical Research Center ( Site 1112)
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Everett, Washington, United States, 98201
- Core Clinical Research ( Site 1081)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MK-1942 Daily Dose Group
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.
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MK-1942 (5 mg or 10 mg capsules) titrated from 5 mg to 20 mg dose BID or 10 mg BIW over 4 weeks.
Dose matched placebo capsules BID orally over 4 weeks.
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Experimental: MK-1942 Intermittent Dose Group
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.
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MK-1942 (5 mg or 10 mg capsules) titrated from 5 mg to 20 mg dose BID or 10 mg BIW over 4 weeks.
Dose matched placebo capsules BID orally over 4 weeks.
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Placebo Comparator: Placebo
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.
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Dose matched placebo capsules BID orally over 4 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 3
Time Frame: Baseline, Week 3
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The 10-item MADRS scale will be used to evaluate the severity of depressive symptoms.
Participants receiving daily dose of MK-1942 will be rated on 10 items, rated on a scale from 0 (normal, no symptom) to 6 (symptoms of maximum severity) with total scores ranging from 0 (normal/no symptom) to 60 (severe depression).
Higher scores correspond to greater symptom severity.
A negative change score indicates improvement.
The longitudinal analysis of covariance (ANCOVA) model will be used to report the mean change from baseline in the MADRS total score to Week 3.
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Baseline, Week 3
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Change From Baseline in MADRS Total Score to Week 1
Time Frame: Baseline, Week 1
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The 10-item MADRS scale will be used to evaluate the severity of depressive symptoms.
Participants receiving intermittent dose of MK-1942 will be rated on 10 items, rated on a scale from 0 (normal, no symptom) to 6 (symptoms of maximum severity) with total scores ranging from 0 (normal/no symptom) to 60 (severe depression).
Higher scores correspond to greater symptom severity.
A negative change score indicates improvement.
The longitudinal analysis of covariance (ANCOVA) model will be used to report the mean change from baseline in the MADRS total score to Week 1.
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Baseline, Week 1
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Number of Participants Who Experienced An Adverse Event (AE)
Time Frame: Up to approximately 6 Weeks
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Up to approximately 6 Weeks
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Number of Participants Who Discontinued Study Treatment Due to an AE
Time Frame: Up to approximately 4 Weeks
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
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Up to approximately 4 Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in the Hamilton Depression Rating Scale (HAM-D17) Total Score to Week 3
Time Frame: Baseline, Week 3
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The 17 item HAM-D17 scale will be used to evaluate the depressive symptoms experienced over the past week among participants who received daily dose of MK-1942.
Participants will be rated using 17 individual items.
Each item is rated on a scale from 0 to 2 or 0 to 4 reflective of severity (0 being absence of symptom and higher scores being more severe), with total scores ranging from 0 (no apparent symptoms) to 52 (most severe symptoms).
Higher scores correspond to greater symptom.
A negative change score indicates improvement.
The longitudinal ANCOVA model will be used to report the mean change from baseline in HAM-D17 total score to Week 3.
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Baseline, Week 3
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Change From Baseline in the HAM-D17 Scale Total Score to Week 1
Time Frame: Baseline, Week 1
|
The 17 item HAM-D17 scale will be used to evaluate the depressive symptoms experienced over the past week among participants who received intermittent dose of MK-1942.
Participants will be rated using 17 individual items.
Each item is rated on a scale from 0 to 2 or 0 to 4 reflective of severity (0 being absence of symptom and higher scores being more severe), with total scores ranging from 0 (no apparent symptoms) to 52 (most severe symptoms).
Higher scores correspond to greater symptom severity.
A negative change score indicates improvement.
The longitudinal ANCOVA model will be used to report the mean change from baseline in HAM-D17 total score to Week 1.
|
Baseline, Week 1
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Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 3
Time Frame: Baseline, Week 3
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A single-item CGI-S scale will be used to assess the severity of depression among participants who received daily dose of MK-1942.
The CGI-S is rated on a 7-point scale using a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Higher score corresponds to greater symptom severity.
A negative change score indicates improvement.
The longitudinal ANCOVA model will be used to report the mean change from baseline in CGI-S score to Week 3.
|
Baseline, Week 3
|
Change From Baseline in the CGI-S Total Score to Week 1
Time Frame: Baseline, Week 1
|
A single-item CGI-S scale will be used to assess the severity of depression among participants who received intermittent dose of MK-1942.
The CGI-S is rated on a 7-point scale using a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Higher score corresponds to greater symptom severity.
A negative change score indicates improvement.
The longitudinal ANCOVA model will be used to report the mean change from baseline in CGI-S score to Week 1.
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Baseline, Week 1
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Mean Plasma Concentration of MK-1942 plasma concentration
Time Frame: Week 0 (Day 1): Predose and 1-hour postdose and Weeks 1, 2, 3 & 4: Predose
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Blood samples will be collected at predetermined predose and postdose specified timepoints to report the mean plasma concentration of MK-1942 at prespecified timepoints.
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Week 0 (Day 1): Predose and 1-hour postdose and Weeks 1, 2, 3 & 4: Predose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Director, Merck Sharp & Dohme LLC
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 20, 2021
Primary Completion (Actual)
September 8, 2023
Study Completion (Actual)
September 8, 2023
Study Registration Dates
First Submitted
December 4, 2020
First Submitted That Met QC Criteria
December 4, 2020
First Posted (Actual)
December 11, 2020
Study Record Updates
Last Update Posted (Actual)
September 28, 2023
Last Update Submitted That Met QC Criteria
September 26, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1942-006
- MK-1942-006 (Other Identifier: Merck Protocol Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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