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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
99
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 3
The change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score is presented. MADRS includes 10 participant-rated items, each scored on a scale from 0 (normal, no symptom) to 6 (symptoms of maximum severity) \[total scores range from 0 (normal/no symptom) to 60 (severe depression). Higher scores correspond to greater symptom severity, whereas a negative change from baseline score indicates improvement.
Time frame: Baseline and Week 3
Change From Baseline in MADRS Total Score to Week 1
The change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) score is presented. MADRS includes 10 participant-rated items, each scored on a scale from 0 (normal, no symptom) to 6 (symptoms of maximum severity) \[total scores range from 0 (normal/no symptom) to 60 (severe depression). Higher scores correspond to greater symptom severity, whereas a negative change from baseline score indicates improvement.
Time frame: Baseline and Week 1
Number of Participants Who Experienced An Adverse Event (AE)
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.
Time frame: Up to approximately 6 Weeks
Number of Participants Who Discontinued Study Treatment Due to an AE
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.
Time frame: Up to approximately 4 Weeks
Change From Baseline in the Hamilton Depression Rating Scale (HAM-D17) Total Score to Week 3
The HAM-D17 scale was used to evaluate the depressive symptoms experienced over the past week. The HAM-D17 is a 17-item participant-rated scale, with each item scored from 0 to 2 or 4 (depending on the question) reflective of severity (0 is absence of symptom and higher scores indicate greater symptom severity). The total score ranges from 0 (no apparent symptoms) to 52 (most severe symptoms). A negative change from baseline indicates symptom improvement, and vice versa.
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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
...and 35 more locations
Time frame: Baseline and Week 3
Change From Baseline in the HAM-D17 Scale Total Score to Week 1
The HAM-D17 scale was used to evaluate the depressive symptoms experienced over the past week. The HAM-D17 is a 17-item participant-rated scale, with each item scored from 0 to 2 or 4 (depending on the question) reflective of severity (0 is absence of symptom and higher scores indicate greater symptom severity). The total score ranges from 0 (no apparent symptoms) to 52 (most severe symptoms). A negative change from baseline indicates symptom improvement, and vice versa.
Time frame: Baseline and Week 1
Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 3
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, and vice versa.
Time frame: Baseline and Week 3
Change From Baseline in the Clinician Global Impression-Severity (CGI-S) Total Score to Week 1
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, and vice versa.
Time frame: Baseline and Week 1
Mean Plasma Concentration of MK-1942 Plasma Concentration
The mean plasma concentration of MK-1942 10 mg given as a single or multiple dose regimen was determined.
Time frame: Day 15: 12 (Daily Dose) or 72 (Intermittent Dose) hours postdose