Depression Clinical Trial
Official title:
Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study
Verified date | September 2019 |
Source | Wake Forest University Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 69 |
Est. completion date | September 20, 2019 |
Est. primary completion date | September 20, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest Baptist Medical Center | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Adherence to Intervention | Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit) | 12 weeks | |
Secondary | Accrual | Percentage of patients screened for the trial who are eligible | baseline | |
Secondary | Participants Eligible for Consent Into Treatment Arms | Percent eligible who consent to participate in treatment study | baseline | |
Secondary | Retention | Percentage of participants who complete the 12 week outcome assessment | 12 weeks | |
Secondary | Efficacy - Depression Symptoms | Using Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome. | baseline | |
Secondary | Efficacy - Depression Symptoms | Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome. | 12 weeks | |
Secondary | Efficacy - Anxiety Symptoms | Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes. | baseline | |
Secondary | Efficacy - Anxiety Symptoms | Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes. | 12 weeks |
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