Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram

NCT04388202 | Withdrawn Phase 4 DMC

• 2 other identifiers: LEAP-SE1R44MH123373-01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The LEAP-SE 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; Sertraline; Escitalopram

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

  Response rate will be calculated as the percentage of participants meeting response criteria (\>50% reduction from baseline QIDS-SR total score at 8-week endpoint). The QIDS-SR is a 16-item, participant-rated short form of the Inventory of Depressive Symptomatology that assesses 9 domains: sad mood, concentration, self-outlook, suicidal ideation, involvement, energy/fatigability, sleep disturbance, appetite/weight increase/decrease and psychomotor agitation/retardation. Scores range from 0 (none) to 27 (very severe). The QIDS-SR total score was used to derive the mean change from baseline to endpoint depression.

  8 weeks

Secondary Outcomes (2)

• Percentage decrease in depressive symptoms on the patient-reported Quick Inventory of Depressive Symptoms (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)

Sertraline

EXPERIMENTAL

Sertraline 100-200 mg daily for 8 weeks

Drug: Sertraline

Escitalopram

ACTIVE COMPARATOR

Escitalopram 10-20 mg daily for 8 weeks

Drug: Escitalopram

Interventions

Sertraline DRUG

FDA approved antidepressant

Also known as: Zoloft

Sertraline

Escitalopram DRUG

FDA approved antidepressant

Also known as: Lexapro

Escitalopram

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 (sertraline, escitalopram) 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 antidepressants, 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 within 2 months prior to the first study visit

Sponsors & Collaborators

• Alto Neuroscience: lead
• National Institute of Mental Health (NIMH): collaborator

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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