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

A

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Withdrawn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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Sertraline
Experimental group
Description:
Sertraline 100-200 mg daily for 8 weeks
Treatment:
Drug: Sertraline
Escitalopram
Active Comparator group
Description:
Escitalopram 10-20 mg daily for 8 weeks
Treatment:
Drug: Escitalopram

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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