Back to results

Anxiety and Depression in Epilepsy: A Pilot Treatment Study

Primary Purpose

Anxiety, Depression, Epilepsy

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Escitalopram 10mg

About this trial

This is an interventional treatment trial for Anxiety focused on measuring Neurologic Disorders, Chronic Care, Management, Treatment, SSRI Medication, SNRI Medication, Learning Healthcare System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Provision of signed and dated informed consent form
Stated willingness to comply with all study procedures and availability for the duration of the study
Age 18 or older
Ability to take oral medication and the willing to adhere to the intervention regimen
Minimum of 1 prior clinic visit at the Comprehensive Epilepsy Center
Adequate cognition (MoCA score of 20 or greater)
Diagnosis of epilepsy: EEG with documented seizure or epileptiform discharges OR non-epileptiform EEG and seizure remission with antiseizure drug OR treating epileptologist's leading clinical impression is epilepsy
NDDI-E score greater than 15 and/or GAD-7 score greater than or equal to 10

Exclusion Criteria:

Pregnancy or lactation
Known allergic reactions to escitalopram or venlafaxine
Comorbid psychogenic nonepileptic seizures
Prior psychiatric hospitalization
Prior suicide attempt
History of manic or psychotic symptoms (past manic episode (SCID-I), or psychotic symptom screen positive)
Current treatment by a psychiatrist or counselor/theraptist
Active suicidality at the time of screening
Current treatment with buspirone or an SSRI/SNRI/atypical antidepressant (specifically bupropion, fluoxetine, levomilnacipran, citalopram, milnacipran, desvenlafaxine, mirtazapine, duloxetine, paroxetine, escitalopram, sertraline, fluvoxamine, venlafaxine, vilazodone, vortioxetine)

Sites / Locations

Wake Forest Baptist Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epileptologist-Driven Treatment

Arm Description

The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose adjustment will be made based on biweekly repeated screening of anxiety and depression symptoms, as well as side effects identified on biweekly telephone calls or the 6-week advanced practice provider (APP) follow up visit. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).

Outcomes

Primary Outcome Measures

Adherence to Intervention

Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit)

Secondary Outcome Measures

Accrual

Percentage of patients screened for the trial who are eligible

Full Information

NCT ID

NCT03522987

First Posted

April 20, 2018

Last Updated

September 11, 2019

Sponsor

Wake Forest University Health Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03522987

Brief Title

Anxiety and Depression in Epilepsy: A Pilot Treatment Study

Official Title

Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Decided not to perform the pilot phase

Study Start Date

May 2018 (Anticipated)

Primary Completion Date

May 2018 (Anticipated)

Study Completion Date

May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

As a potential solution to address high rates of depression and anxiety seen in epilepsy patients and poor mental health care access, this trial aims to carry out treatment for depression and anxiety directly in the epilepsy clinic. Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be enrolled in the intervention. The intervention will consist of an initial prescription for an FDA-approved medication to treat depression/anxiety and telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The purpose of this pre-piloting limited study is to streamline recruitment, intervention and outcome assessment process in preparation for a randomized, controlled pilot of the intervention.

Detailed Description

This trial is an innovative learning healthcare system approach to translate the concept of measurement-based depression care into a specialty clinic setting and extend the concept to treat depression and/or anxiety. The neurologist/APP-administered medication intervention utilizes FDA-approved drugs with advantageous features for use in epilepsy (escitalopram and venlafaxine) and a telephone-based chronic care management plan for repeated symptom measurement and side effect surveillance. The proposed intervention may overcome barriers to implementing mental health treatment interventions in generalized clinical settings by using healthcare providers commonly present in specialty clinics (physicians and APPs) along with a billable, best practices chronic care management intervention package. To test this idea, the study team seeks to pilot a feasibility trial of an epileptologist-driven medication treatment intervention for anxiety and depression, carried out directly in the epilepsy clinic during a regularly scheduled visit and supported by advanced practice provider (APP), using epilepsy as a paradigm for chronic medical illness with high prevalence of psychiatric comorbidity. In this limited, intervention only pre-piloting trial, the team will streamline recruitment, intervention, and outcome assessment procedures to prepare for a randomized, controlled pilot of the intervention.

6. Conditions and Keywords

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

Anxiety, Depression, Epilepsy

Keywords

Neurologic Disorders, Chronic Care, Management, Treatment, SSRI Medication, SNRI Medication, Learning Healthcare System

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Epileptologist-driven medication treatment intervention for anxiety and depression, carried out directly in the epilepsy clinic during a regularly scheduled visit and supported by advanced practice provider (APP).

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epileptologist-Driven Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Escitalopram 10mg

Other Intervention Name(s)

Lexapro

Intervention Description

Participants will be given escitalopram 10mg by mouth daily and will be followed up at 2, 4, 6, 8, and 10 weeks. Medication will be adjusted if side effects occur. If unable to tolerate escitalopram, then venlafaxine XR (Effexor XR) 37.5mg will be substituted.

Primary Outcome Measure Information:

Title

Adherence to Intervention

Description

Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit)

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Accrual

Description

Percentage of patients screened for the trial who are eligible

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Age 18 or older Ability to take oral medication and the willing to adhere to the intervention regimen Minimum of 1 prior clinic visit at the Comprehensive Epilepsy Center Adequate cognition (MoCA score of 20 or greater) Diagnosis of epilepsy: EEG with documented seizure or epileptiform discharges OR non-epileptiform EEG and seizure remission with antiseizure drug OR treating epileptologist's leading clinical impression is epilepsy NDDI-E score greater than 15 and/or GAD-7 score greater than or equal to 10 Exclusion Criteria: Pregnancy or lactation Known allergic reactions to escitalopram or venlafaxine Comorbid psychogenic nonepileptic seizures Prior psychiatric hospitalization Prior suicide attempt History of manic or psychotic symptoms (past manic episode (SCID-I), or psychotic symptom screen positive) Current treatment by a psychiatrist or counselor/theraptist Active suicidality at the time of screening Current treatment with buspirone or an SSRI/SNRI/atypical antidepressant (specifically bupropion, fluoxetine, levomilnacipran, citalopram, milnacipran, desvenlafaxine, mirtazapine, duloxetine, paroxetine, escitalopram, sertraline, fluvoxamine, venlafaxine, vilazodone, vortioxetine)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heidi Munger Clary, MD

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Anxiety and Depression in Epilepsy: A Pilot Treatment Study

We'll reach out to this number within 24 hrs