Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006)

NCT ID: NCT04663321

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-20
• Study Completion Date: 2023-09-08

Brief Summary

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 or intermittent MK-1942 treatment are superior to placebo in reducing Montgomery-Asberg Depression Rating Scale (MADRS) score.

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

MK-1942

Intervention Type: DRUG

MK-1942 (5 mg or 10 mg capsules) titrated from 5 mg to 20 mg dose BID or 10 mg BIW over 4 weeks.

Placebo

Intervention Type: DRUG

Dose matched placebo capsules BID orally over 4 weeks.

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.

Group Type: EXPERIMENTAL

MK-1942

Intervention Type: DRUG

MK-1942 (5 mg or 10 mg capsules) titrated from 5 mg to 20 mg dose BID or 10 mg BIW over 4 weeks.

Placebo

Intervention Type: DRUG

Dose matched placebo capsules BID orally over 4 weeks.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Dose matched placebo capsules BID orally over 4 weeks.

Interventions

MK-1942

MK-1942 (5 mg or 10 mg capsules) titrated from 5 mg to 20 mg dose BID or 10 mg BIW over 4 weeks.

Intervention Type: DRUG

Placebo

Dose matched placebo capsules BID orally over 4 weeks.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Birmingham, Alabama, United States

Preferred Research Partners ( Site 1079)

Little Rock, Arkansas, United States

Woodland International Research Group ( Site 1017)

Little Rock, Arkansas, United States

CITrials-Outpatient Facility ( Site 1098)

Bellflower, California, United States

Axiom Research ( Site 1053)

Colton, California, United States

Collaborative Neuroscience Network, LLC. ( Site 1032)

Garden Grove, California, United States

CITrials ( Site 1105)

Santa Ana, California, United States

Institute of Living ( Site 1061)

Hartford, Connecticut, United States

Gulfcoast Clinical Research Center ( Site 1110)

Fort Myers, Florida, United States

Velocity Clinical Research, Hallandale Beach ( Site 1116)

Hallandale, Florida, United States

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

Jacksonville, Florida, United States

Innovative Clinical Research ( Site 1044)

Lauderhill, Florida, United States

Behavioral Clinical Research ( Site 1037)

Miami, Florida, United States

Aqualane Clinical Research ( Site 1113)

Naples, Florida, United States

APG RESEARCH, LLC ( Site 1087)

Orlando, Florida, United States

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

Tampa, Florida, United States

K2 Medical Research - Winter Park ( Site 1115)

Winter Park, Florida, United States

Atlanta Center for Medical Research ( Site 1022)

Atlanta, Georgia, United States

iResearch Atlanta ( Site 1040)

Decatur, Georgia, United States

Psych Atlanta ( Site 1108)

Marietta, Georgia, United States

iResearch Savannah ( Site 1041)

Savannah, Georgia, United States

Ascension Saint Elizabeth ( Site 1003)

Chicago, Illinois, United States

CBH Health ( Site 1076)

Gaithersburg, Maryland, United States

Boston Clinical Trials ( Site 1028)

Boston, Massachusetts, United States

University of Michigan-Psychiatry ( Site 1051)

Ann Arbor, Michigan, United States

Altea Research ( Site 1018)

Las Vegas, Nevada, United States

Hassman Research Institute ( Site 1036)

Berlin, New Jersey, United States

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

Princeton, New Jersey, United States

Albuquerque Neuroscience Inc. ( Site 1107)

Albuquerque, New Mexico, United States

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

New York, New York, United States

Manhattan Behavioral Medicine ( Site 1096)

New York, New York, United States

Richmond Behavioral Associates ( Site 1011)

Staten Island, New York, United States

New Hope Clinical Research ( Site 1082)

Charlotte, North Carolina, United States

Clinical Trials of America, LLC ( Site 1103)

Hickory, North Carolina, United States

Neuro-Behavioral Clinical Research ( Site 1045)

North Canton, Ohio, United States

Paradigm Research Professionals ( Site 1089)

Oklahoma City, Oklahoma, United States

Suburban Research Associates-Clinical Research ( Site 1042)

Media, Pennsylvania, United States

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

Philadelphia, Pennsylvania, United States

Keystone Clinical Studies ( Site 1031)

Plymouth Meeting, Pennsylvania, United States

Baylor College of Medicine ( Site 1019)

Houston, Texas, United States

AIM Trials, LLC ( Site 1111)

Plano, Texas, United States

Cedar Clinical Research ( Site 1023)

Draper, Utah, United States

Woodstock Research Center ( Site 1084)

Woodstock, Vermont, United States

Northwest Clinical Research Center ( Site 1112)

Bellevue, Washington, United States

Core Clinical Research ( Site 1081)

Everett, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

MK-1942-006

Identifier Type: OTHER

Identifier Source: secondary_id

1942-006

Identifier Type: -

Identifier Source: org_study_id