Clinical trial NCT03522987: 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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Anxiety
Depression
Epilepsy
Keywords: Neurologic Disorders
Chronic Care
Management
Treatment
SSRI Medication
SNRI Medication
Learning Healthcare System
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Adherence to Intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Accrual
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi Munger Clary, MD
role: PRINCIPAL_INVESTIGATOR
References: