The LEAP-SE study will be conducted to validate the utility of EEG biomarkers as an aid to antidepressant treatment selection in adults with MDD.
The LEAP-SE study is an 8-week, multicenter, randomized, blinded study to evaluate the performance of EEG-based biomarkers in predicting treatment outcome. Study participants will be randomized in a 1:1 ratio to receive either sertraline or escitalopram and followed for 8 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
FDA approved antidepressant
FDA approved antidepressant
Response rate on the 16-item patient-reported Quick Inventory of Depressive Symptoms (QIDS-SR) at the week 8 endpoint as a function of biomarker score
Response rate will be calculated as the percentage of participants meeting response criteria (\>50% reduction from baseline QIDS-SR total score at 8-week endpoint). The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.
Time frame: 8 weeks
Percentage decrease in depressive symptoms on the patient-reported Quick Inventory of Depressive Symptoms (QIDS-SR) at the week 8 endpoint as a function of biomarker score
Quick Inventory of Depressive Symptoms (QIDS-SR)
Time frame: 8 weeks
Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score
Quick Inventory of Depressive Symptoms (QIDS-SR)
Time frame: 8 weeks
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