Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram

Major Depressive Disorder Clinical Trial

— LEAP-SE  

Official title:

Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram (LEAP-SE): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Sertraline Versus Escitalopram in Adults With Major Depressive Disorder

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04388202
• Other study ID #: LEAP-SE
• Secondary ID: 1R44MH123373-01
• Status: Withdrawn
• Phase: Phase 4
• Start date: October 15, 2020
• Est. completion date: May 30, 2023

Study information

• Verified date: October 2020
• Source: Alto Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The LEAP-SE 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 sertraline or escitalopram and followed for 8 weeks.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 30, 2023
• Est. primary completion date: May 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 85 Years

Eligibility

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 (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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Sertraline
FDA approved antidepressant
• Escitalopram
FDA approved antidepressant

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alto Neuroscience	National Institute of Mental Health (NIMH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Quick Inventory of Depressive Symptoms (QIDS-SR)	8 weeks
Secondary	Absolute score decrease from baseline to the week 8 endpoint on the QIDS-SR as a function of biomarker score	Quick Inventory of Depressive Symptoms (QIDS-SR)	8 weeks