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WithdrawnNCT04388189LEAP-DBUpdated Oct 19, 2020

Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion

A Phase 4 interventional study of Duloxetine and Bupropion in Major Depressive Disorder, sponsored by Alto Neuroscience. Withdrawn. Open to participants aged 22 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-10-19.

Sponsored by Alto Neuroscience · Phase 4, Interventional, and Treatment

Why this study was withdrawn
No participants enrolled
Phase
Phase 4
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
22 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Major Depressive Disorder
  • EEG
  • Biomarker
  • Antidepressant
  • Duloxetine
  • Bupropion
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

Browse Depressive Disorder studies →

Lead sponsor

Alto Neuroscience is the lead sponsor of 11 studies on the registry; 4 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 85 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Duloxetine

    Duloxetine 60 mg daily for 8 weeks

    Drug: Duloxetine

  • Active comparator
    Bupropion

    Bupropion 150-450 mg daily for 8 weeks

    Drug: Bupropion

Interventions

  • DrugDuloxetine

    FDA approved antidepressant

    Also known as: Cymbalta

  • DrugBupropion

    FDA approved antidepressant

    Also known as: Wellbutrin

06

What researchers measure

Primary outcomes

  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

    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 outcomes

  1. 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)

    Time frame: 8 weeks

  2. 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)

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 19, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04388189
Lead sponsor
Alto Neuroscience
Responsible party
Sponsor
First posted
May 14, 2020
Start date
Oct 15, 2020 (estimated)
Primary completion
May 30, 2023 (estimated)
Completion
May 30, 2023 (estimated)
Last update
Oct 19, 2020

Study contacts

Corey Keller, MD, PhD
study director · Alto Neuroscience

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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