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

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ClinicalTrials.gov Identifier: NCT04388202
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : May 14, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Alto Neuroscience

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
Major Depressive Disorder Drug: Sertraline Drug: Escitalopram 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.

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023


Arm Intervention/treatment
Experimental: Sertraline
Sertraline 100-200 mg daily for 8 weeks
Drug: Sertraline
FDA approved antidepressant
Other Name: Zoloft

Active Comparator: Escitalopram
Escitalopram 10-20 mg daily for 8 weeks
Drug: Escitalopram
FDA approved antidepressant
Other Name: Lexapro




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 [ 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 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 [ Time Frame: 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 [ Time Frame: 8 weeks ]
    Quick Inventory of Depressive Symptoms (QIDS-SR)



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04388202


Sponsors and Collaborators
Alto Neuroscience
National Institute of Mental Health (NIMH)
Investigators
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Study Director: Corey Keller, MD, PhD Alto Neuroscience
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Responsible Party: Alto Neuroscience
ClinicalTrials.gov Identifier: NCT04388202    
Other Study ID Numbers: LEAP-SE
1R44MH123373-01 ( U.S. NIH Grant/Contract )
First Posted: May 14, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Major Depressive Disorder
EEG
Biomarker
Antidepressant
Sertraline
Escitalopram
Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Citalopram
Sertraline
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs