Trial Outcomes & Findings for Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD (NCT NCT02977299)

Participants were enrolled across 17 sites in the United States and Canada between July 13, 2017 and December 22, 2021.

Eligible participants with treatment-resistant depression receiving stable antidepressant therapy were randomized in a 1:1:1 ratio to aripiprazole augmentation, rTMS augmentation, or switch to venlafaxine XR/duloxetine.

Baseline demographic and clinical characteristics were assessed in all randomized participants

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-rated scale that assesses the severity of depressive symptoms. The scale consists of 10 items evaluating apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 to 6. Item scores are summed to calculate a total MADRS score ranging from 0 to 60, with higher scores indicating more severe depressive symptoms and a worse outcome.

The Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF) is a self-reported assessment tool used to evaluate an individual's degree of enjoyment and satisfaction across various areas of daily functioning. The questionnaire assesses domains such as physical health, mood, work, household activities, social relationships, leisure activities, and overall well-being. The short form consists of 16 items, with respondents rating their level of satisfaction and functioning over the past week. The first 14 items are summed to generate a total raw score ranging from 14 to 70, with higher scores indicating greater life satisfaction and better quality of life. Raw scores may also be converted to a percentage of the maximum possible score, ranging from 0% to 100%, to facilitate interpretation and comparison across studies. The final two items assess overall medication satisfaction and overall life satisfaction and are typically analyzed separately rather than included

The Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH CPFQ) is a self-reported assessment tool designed to evaluate cognitive and physical symptoms commonly associated with depression and its treatment. The questionnaire assesses areas such as motivation, wakefulness, energy, focus, memory, mental sharpness, and physical well-being. The instrument consists of 7 items, each rated on a 6-point scale from 1 (greater than normal functioning) to 6 (totally absent or severe impairment). Item scores are summed to generate a total score ranging from 7 to 42, with higher scores indicating greater impairment in cognitive and physical functioning. The MGH CPFQ is widely used in clinical research to assess functional deficits associated with depression and to monitor changes in cognitive and physical symptoms during treatment.