Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram (LEAP-SE)

Alto Neuroscience

Status and phase

Withdrawn

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Escitalopram

Drug: Sertraline

Study type

Interventional

Funder types

Industry

NIH

Identifiers

NCT04388202

1R44MH123373-01 (U.S. NIH Grant/Contract)

LEAP-SE

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

22 to 85 years old

Volunteers

No Healthy Volunteers

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-5.
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