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

Sponsor
Alto Neuroscience (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04388202
Collaborator
National Institute of Mental Health (NIMH) (NIH)
0
2
31.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Anticipated Study Start Date :
Oct 15, 2020
Anticipated Primary Completion Date :
May 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sertraline

Sertraline 100-200 mg daily for 8 weeks

Drug: Sertraline
FDA approved antidepressant
Other Names:
  • Zoloft
  • Active Comparator: Escitalopram

    Escitalopram 10-20 mg daily for 8 weeks

    Drug: Escitalopram
    FDA approved antidepressant
    Other Names:
  • Lexapro
  • Outcome Measures

    Primary Outcome Measures

    1. 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 [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 Outcome Measures

    1. 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]

      Quick Inventory of Depressive Symptoms (QIDS-SR)

    2. Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score [8 weeks]

      Quick Inventory of Depressive Symptoms (QIDS-SR)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Alto Neuroscience
    • National Institute of Mental Health (NIMH)

    Investigators

    • Study Director: Corey Keller, MD, PhD, Alto Neuroscience

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alto Neuroscience
    ClinicalTrials.gov Identifier:
    NCT04388202
    Other Study ID Numbers:
    • LEAP-SE
    • 1R44MH123373-01
    First Posted:
    May 14, 2020
    Last Update Posted:
    Oct 19, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Alto Neuroscience
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2020