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Efficacy and Safety of MK-1942 When Added to Stable Antidepressant Therapy in Participants With Treatment-Resistant Depression (TRD) (MK-1942-006)
Sponsor: Merck Sharp & Dohme LLC
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2021-05-20
Completion Date
2023-09-08
Last Updated
2026-05-04
Healthy Volunteers
No
Conditions
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.
Placebo
Dose matched placebo capsules BID orally over 4 weeks.
Locations (45)
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