Clinical trial NCT03464383: Anxiety and Depression in Epilepsy: A Treatment Study
Official title: Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
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: 2018-03-14
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two groups. Those randomized to the intervention group will receive an epileptologist-driven medication treatment for anxiety and depression, carried out directly in the epilepsy clinic during a regularly scheduled visit and supported by advanced practice provider (APP). Those randomized to the control group will receive an referral order to psychiatry placed by their epileptologist.
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 randomized trial aims to study treatment for anxiety and depression in epilepsy taking place directly within the epilepsy clinic vs. psychiatry referral (typical care). Patients that meet eligibility criteria, including significant symptoms of depression and/or anxiety, will be randomized to the either the intervention group or the control group. Patients that do not meet eligibility requirement or decline the study intervention will have the option of participating in the survey arm of the study. 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 control group will receive usual care, which is a referral order to psychiatry placed by their treating neurologist. Participants in the survey arm of the study will complete a one time survey.

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 investigators' 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 and EMR-based clinical tools.To test this idea, the investigators seek to pilot a randomized trial of neurologist/APP medication management of depression and anxiety versus usual care with psychiatry referral in the epilepsy clinic, using epilepsy as a paradigm for chronic medical illness with high prevalence of psychiatric comorbidity. The optional survey arm is to help investigators understand the population that do not meet criteria or refuse 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
* Ability to complete questionnaires independently
* 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
* (Neurological Disorders Depression Inventory for epilepsy, NDDI-E score greater than 15 and/or Generalized Anxiety Disorder-7, 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/therapist
* 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: baseline
measure: Participants Eligible for Consent Into Treatment Arms
timeFrame: baseline
measure: Retention
timeFrame: 12 weeks
measure: Efficacy - Depression Symptoms
timeFrame: baseline
measure: Efficacy - Depression Symptoms
timeFrame: 12 weeks
measure: Efficacy - Anxiety Symptoms
timeFrame: baseline
measure: Efficacy - Anxiety Symptoms
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: