Anxiety and Depression in Epilepsy: A Pilot Treatment Study

NCT03522987 | Withdrawn Phase 4 DMC FDA Drug

• 2 other identifiers: IRB00048584-1st5UL1TR001420-03
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Epilepsy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

  12 weeks

Secondary Outcomes (1)

• Accrual

  12 weeks

Study Arms (1)

Epileptologist-Driven Treatment

EXPERIMENTAL

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).

Drug: Escitalopram 10mg

Interventions

Escitalopram 10mg DRUG

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.

Also known as: Lexapro

Epileptologist-Driven Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression; Epilepsy; Nervous System Diseases

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Heidi Munger Clary, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 14, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: September 12, 2019

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)