Anxiety and Depression in Epilepsy: A Treatment Study
Condition: Anxiety; Depression; Epilepsy
MeSH terms: Epilepsy; Depression; Depressive Disorder; Anxiety Disorders
Intervention: Escitalopram 10mg; Referral to Psychiatry; Survey only
Intervention description: Participants will be given escitalopram 10mg by mouth daily and will be followed up with 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.; Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance.; One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Outcomes Assessor)
Masking description: Outcome assessment phone calls for gathering scaled instrument scores will be carried out by a second study coordinator, blinded to treatment assignment.
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Neurologic Disorders; Chronic Care; Management; Treatment; SSRI Medication; SNRI Medication; Learning Healthcare System

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.
    

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)