Leveraging EEG for Antidepressant Prediction With Duloxetine and Bupropion

NCT04388189 | Withdrawn Phase 4 DMC

• 1 other identifier: LEAP-DB
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; EEG; Biomarker; Antidepressant; Duloxetine; Bupropion

Outcome Measures

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.

  8 weeks

Secondary Outcomes (2)

• Percentage decrease in depressive symptoms on the QIDS-SR at the week 8 endpoint as a function of biomarker score

  8 weeks

• Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score

  8 weeks

Study Arms (2)

Duloxetine

EXPERIMENTAL

Duloxetine 60 mg daily for 8 weeks

Drug: Duloxetine

Bupropion

ACTIVE COMPARATOR

Bupropion 150-450 mg daily for 8 weeks

Drug: Bupropion

Interventions

Duloxetine DRUG

FDA approved antidepressant

Also known as: Cymbalta

Duloxetine

Bupropion DRUG

FDA approved antidepressant

Also known as: Wellbutrin

Bupropion

Eligibility Criteria

• Age: 22 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alto Neuroscience: lead

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride; Bupropion

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Propiophenones; Ketones

Study Officials

• Corey Keller, MD, PhD

  Alto Neuroscience

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2020
• First Posted: May 14, 2020
• Study Start: October 15, 2020
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: October 19, 2020

Record last verified: 2020-10