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Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram (LEAP-SE)

Primary Purpose

Major Depressive Disorder

Status

Withdrawn

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Sertraline

Escitalopram

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, EEG, Biomarker, Antidepressant, Sertraline, Escitalopram

Eligibility Criteria

22 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sertraline

Escitalopram

Arm Description

Sertraline 100-200 mg daily for 8 weeks

Escitalopram 10-20 mg daily for 8 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

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)

Full Information

NCT ID

NCT04388202

First Posted

May 11, 2020

Last Updated

October 13, 2020

Sponsor

Alto Neuroscience

Collaborators

National Institute of Mental Health (NIMH)

1. Study Identification

Unique Protocol Identification Number

NCT04388202

Brief Title

Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Withdrawn

Why Stopped

No participants enrolled

Study Start Date

October 15, 2020 (Anticipated)

Primary Completion Date

May 30, 2023 (Anticipated)

Study Completion Date

May 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alto Neuroscience

Collaborators

National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Major Depressive Disorder, EEG, Biomarker, Antidepressant, Sertraline, Escitalopram

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sertraline

Arm Type

Experimental

Arm Description

Sertraline 100-200 mg daily for 8 weeks

Arm Title

Escitalopram

Arm Type

Active Comparator

Arm Description

Escitalopram 10-20 mg daily for 8 weeks

Intervention Type

Drug

Intervention Name(s)

Sertraline

Other Intervention Name(s)

Zoloft

Intervention Description

FDA approved antidepressant

Intervention Type

Drug

Intervention Name(s)

Escitalopram

Other Intervention Name(s)

Lexapro

Intervention Description

FDA approved antidepressant

Primary Outcome Measure Information:

Title

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

Description

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

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

Description

Quick Inventory of Depressive Symptoms (QIDS-SR)

Time Frame

8 weeks

Title

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

Description

Quick Inventory of Depressive Symptoms (QIDS-SR)

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

22 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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 (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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Corey Keller, MD, PhD

Organizational Affiliation

Alto Neuroscience

Official's Role

Study Director

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram

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