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TERMINATED
NCT04663321
PHASE2

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

View on ClinicalTrials.gov

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

Interventions

DRUG

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.

DRUG

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