Anxiety and Depression in Epilepsy: A Pilot Treatment Study

Wake Forest University (WFU)

Status and phase: Withdrawn; Phase 4

Conditions: Epilepsy; Depression; Anxiety

Treatments: Drug: Escitalopram 10mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03522987

IRB00048584-1st

5UL1TR001420-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Epileptologist-Driven Treatment

Experimental group

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).

Treatment:

Drug: Escitalopram 10mg