Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion

NCT ID: NCT04388189

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2023-05-30

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duloxetine

Duloxetine 60 mg daily for 8 weeks

Group Type: EXPERIMENTAL

Duloxetine

Intervention Type: DRUG

FDA approved antidepressant

Bupropion

Bupropion 150-450 mg daily for 8 weeks

Group Type: ACTIVE_COMPARATOR

Bupropion

Intervention Type: DRUG

FDA approved antidepressant

Interventions

Duloxetine

FDA approved antidepressant

Intervention Type: DRUG

Bupropion

FDA approved antidepressant

Intervention Type: DRUG

Other Intervention Names

Cymbalta; Wellbutrin

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

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alto Neuroscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Corey Keller, MD, PhD

Role: STUDY_DIRECTOR

Alto Neuroscience

Other Identifiers

LEAP-DB

Identifier Type: -

Identifier Source: org_study_id