Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion

• Status: Withdrawn
• Trial end date: 2023-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alto Neuroscience
• Treatments: Bupropion; Duloxetine Hydrochloride

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