Anxiety and Depression in Epilepsy: A Treatment Study



Status:Enrolling by invitation
Conditions:Anxiety, Depression, Depression, Neurology, Epilepsy
Therapuetic Areas:Neurology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:May 7, 2018
End Date:March 2020

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

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. 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.

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. 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.

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)
We found this trial at
1
site
Winston-Salem, North Carolina 27157
Phone: 336-713-5026
?
mi
from
Winston-Salem, NC
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