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Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion (LEAP-DB)

Primary Purpose

Major Depressive Disorder

Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Duloxetine
Bupropion
Sponsored by
Alto Neuroscience
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, EEG, Biomarker, Antidepressant, Duloxetine, Bupropion

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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 (duloxetine, bupropion) 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 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 that began within less than 2 months prior to the first study visit

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Duloxetine

    Bupropion

    Arm Description

    Duloxetine 60 mg daily for 8 weeks

    Bupropion 150-450 mg daily for 8 weeks

    Outcomes

    Primary Outcome Measures

    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
    The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a 16 item self-report scale that measures depressive symptoms. The QIDS assesses the severity of all DSM-V criterion items required to diagnose a major depressive episode. It asks the patient to rate each of 16 items on a scale from 0 to 3. Additionally, it states the frequency and severity of symptoms that patients should consider while responding to items in the survey. Each item in the survey asks about depressive symptoms that the patient may have experienced in the past seven days.

    Secondary Outcome Measures

    Percentage decrease in depressive symptoms on the QIDS-SR at the week 8 endpoint as a function of biomarker score
    Quick Inventory of Depressive Symptoms (QIDS-SR)
    Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score
    Quick Inventory of Depressive Symptoms (QIDS-SR)

    Full Information

    First Posted
    May 11, 2020
    Last Updated
    October 13, 2020
    Sponsor
    Alto Neuroscience
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04388189
    Brief Title
    Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion
    Acronym
    LEAP-DB
    Official Title
    Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion (LEAP-DB): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Duloxetine Versus Bupropion in Adults With Major Depressive Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No participants enrolled
    Study Start Date
    October 15, 2020 (Anticipated)
    Primary Completion Date
    May 30, 2023 (Anticipated)
    Study Completion Date
    May 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alto Neuroscience

    4. Oversight

    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
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The LEAP-DB 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-DB 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 duloxetine or bupropion and followed for 8 weeks.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depressive Disorder
    Keywords
    Major Depressive Disorder, EEG, Biomarker, Antidepressant, Duloxetine, Bupropion

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Duloxetine
    Arm Type
    Experimental
    Arm Description
    Duloxetine 60 mg daily for 8 weeks
    Arm Title
    Bupropion
    Arm Type
    Active Comparator
    Arm Description
    Bupropion 150-450 mg daily for 8 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Duloxetine
    Other Intervention Name(s)
    Cymbalta
    Intervention Description
    FDA approved antidepressant
    Intervention Type
    Drug
    Intervention Name(s)
    Bupropion
    Other Intervention Name(s)
    Wellbutrin
    Intervention Description
    FDA approved antidepressant
    Primary Outcome Measure Information:
    Title
    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
    Description
    The Quick Inventory of Depressive Symptomatology (QIDS-SR) is a 16 item self-report scale that measures depressive symptoms. The QIDS assesses the severity of all DSM-V criterion items required to diagnose a major depressive episode. It asks the patient to rate each of 16 items on a scale from 0 to 3. Additionally, it states the frequency and severity of symptoms that patients should consider while responding to items in the survey. Each item in the survey asks about depressive symptoms that the patient may have experienced in the past seven days.
    Time Frame
    8 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage decrease in depressive symptoms on the QIDS-SR at the week 8 endpoint as a function of biomarker score
    Description
    Quick Inventory of Depressive Symptoms (QIDS-SR)
    Time Frame
    8 weeks
    Title
    Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score
    Description
    Quick Inventory of Depressive Symptoms (QIDS-SR)
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    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 (duloxetine, bupropion) 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 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 that began within less than 2 months prior to the first study visit
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Corey Keller, MD, PhD
    Organizational Affiliation
    Alto Neuroscience
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion

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