March 14, 2018

Anxiety and Depression in Epilepsy Clinical Trial: A Treatment Study

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. 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.

Anticipated Study Start Date: April 2018
Estimated Primary Completion Date: March 2019
Estimated Study Completion Date: March 2019

Eligibility Criteria

Ages Eligible for Study: 18 Years and older (Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

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 (Montreal Cognitive Assessment, 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
  • (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)