Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram (LEAP-SE): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Sertraline Versus Escitalopram in Adults With Major Depressive Disorder
Overview
- Phase
- Phase 4
- Intervention
- Sertraline
- Conditions
- Major Depressive Disorder
- Sponsor
- Alto Neuroscience
- Primary Endpoint
- 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
- Status
- Withdrawn
- Last Updated
- 5 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female, aged 22 or older at the time of informed consent.
- •Diagnosis of Major Depressive Disorder (MDD) based on the Structured Clinical Interview for DSM-5 for depression.
- •Moderate or severe depression on DSM-5 depression criteria items, as assessed by a score of 10 or more on the Patient Health Questionnaire (PHQ-9)
- •Has not taken either study medications (sertraline, escitalopram) in the current episode
- •Has not received electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or esketamine treatment in the current episode
- •Provision of personally signed and dated written informed consent prior to any study procedures
- •Agrees to, and is eligible for all biomarker assessments (EEG, neurocognitive testing, activity and sleep monitoring, genetic testing)
- •Fluent in English
- •Ability to complete all assessments independently
- •Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria
- •Diagnosis of bipolar disorder or a psychotic disorder based on the Structured Clinical Interview for DSM-
- •Concurrent use of antidepressants, antipsychotics or mood stabilizers
- •Use of hypnotics, anxiolytics or opiate pain medications greater than three days per week and unable to reduce use to three or fewer days per week on an as needed basis
- •Pregnant or breastfeeding
- •Severe impediment to vision, hearing, comprehension, and/or hand movement that interferes with study tasks
- •Active substance use that interferes with ability to consent and/or complete assessments
- •Any contraindication to EEG (e.g. requiring high concentration oxygen)
- •Employees/family of employees of clinic site
- •Participation in another research study within 2 months prior to the first study visit
Arms & Interventions
Sertraline
Sertraline 100-200 mg daily for 8 weeks
Intervention: Sertraline
Escitalopram
Escitalopram 10-20 mg daily for 8 weeks
Intervention: Escitalopram
Outcomes
Primary Outcomes
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
Time Frame: 8 weeks
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.
Secondary Outcomes
- Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score(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(8 weeks)