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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04388189
Recruitment Status : Withdrawn (No participants enrolled)
First Posted : May 14, 2020
Last Update Posted : October 19, 2020
Information provided by (Responsible Party):
Alto Neuroscience

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.

Condition or disease Intervention/treatment Phase
Major Depressive Disorder Drug: Duloxetine Drug: Bupropion Phase 4

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.

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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 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
Estimated Study Start Date : October 15, 2020
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants

Arm Intervention/treatment
Experimental: Duloxetine
Duloxetine 60 mg daily for 8 weeks
Drug: Duloxetine
FDA approved antidepressant
Other Name: Cymbalta

Active Comparator: Bupropion
Bupropion 150-450 mg daily for 8 weeks
Drug: Bupropion
FDA approved antidepressant
Other Name: Wellbutrin

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 ]
    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 :
  1. Percentage decrease in depressive symptoms on the 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT04388189

Sponsors and Collaborators
Alto Neuroscience
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Study Director: Corey Keller, MD, PhD Alto Neuroscience
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Responsible Party: Alto Neuroscience Identifier: NCT04388189    
Other Study ID Numbers: LEAP-DB
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
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Duloxetine Hydrochloride
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Serotonin and Noradrenaline Reuptake Inhibitors
Sensory System Agents
Peripheral Nervous System Agents