To evaluate the efficacy of NBI-1065846 compared with placebo on improving symptoms of anhedonia in participants with major depressive disorder (MDD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
93
Tablets for oral administration
Tablets for oral administration
Neurocrine Clinical Site
Birmingham, Alabama, United States
Change in Anhedonia Severity, as Measured by Change in DARS Score From Baseline to Day 57
The DARS is a dynamic scale that measured desire, motivation, effort and consummatory pleasure across hedonic domains. The DARS is a self-report questionnaire that measured anhedonia across 4 domains: hobbies/past-times, food/drinks, social activities, and sensory experiences. The DARs was rated on a five-point Likert scale from 0 (not at all) to 4 (very much), higher values indicating less anhedonia. All items were summed up to a total score in the range of 0 to 68.
Time frame: Baseline, Day 57
Change in Total MADRS Score From Baseline to Day 57 in Participants With Moderate or Higher Severity Depression
The MADRS is a validated rating scale designed to measure changes in the severity of depressive symptoms. The MADRS consists of 10 items scored on a 7-point scale (0 to 6). Higher MADRS scores indicate more severe depression. The MADRS total score was calculated as the sum of the 10 individual item scores which ranges from 0 to 60.
Time frame: Baseline, Day 57
CGI-S Scores
The CGI-S scale, which is based on a 7-point scale (range: 1=normal, not at all ill, 2 = borderline ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, and 7 = extremely ill), was used to rate the severity of the participants illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis.
Time frame: Baseline and Day 57
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