The LEAP-DB study will be conducted to validate the utility of EEG biomarkers as an aid to antidepressant treatment selection in adults with MDD.
The LEAP-DB 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 duloxetine or bupropion 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
The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a 16 item self-report scale that measures depressive symptoms. The QIDS assesses the severity of all DSM-V criterion items required to diagnose a major depressive episode. It asks the patient to rate each of 16 items on a scale from 0 to 3. Additionally, it states the frequency and severity of symptoms that patients should consider while responding to items in the survey. Each item in the survey asks about depressive symptoms that the patient may have experienced in the past seven days.
Time frame: 8 weeks
Percentage decrease in depressive symptoms on the 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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