Overview

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Withdrawn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