Anxiety and Depression in Epilepsy: A Treatment Study
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|ClinicalTrials.gov Identifier: NCT03464383|
Recruitment Status : Enrolling by invitation
First Posted : March 14, 2018
Last Update Posted : September 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depression Epilepsy||Drug: Escitalopram 10mg Other: Referral to Psychiatry Other: Survey only||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|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.|
|Official Title:||Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study|
|Actual Study Start Date :||May 7, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Epileptologist-Driven Treatment
The intervention will consist of initiating a chronic care management plan in the epilepsy clinic and an initial prescription from the epileptologist for escitalopram 10mg daily. Escitalopram dose adjustment will be made based on biweekly repeated screening of anxiety and depression symptoms, as well as side effects identified on biweekly telephone calls or the 6-week advanced practice provider (APP) follow up visit. Escitalopram dose may be titrated up to a maximum of 20mg daily in 5-10mg increments every 2 weeks for treatment effect, or titrated down to 5mg if needed for adverse effects. If a participant is unable to tolerate escitalopram, then venlafaxine XR 37.5mg will be substituted, to be titrated in a similar manner biweekly based on side effects and anxiety and depression symptoms (with 37.5-75mg increment dose changes and maximum dose of 225mg daily).
Drug: Escitalopram 10mg
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.
Other Name: Lexapro
Active Comparator: Standard of Care
A psychiatry referral order placed by epileptologist under typical care circumstances (internal or external referral based on the participant's geographic preferences). Internal referrals will be processed by current clinic/institutional protocols. External referral orders will be printed and provided to the patient along with brief instructions on how to find a provider covered by the patient's insurance.
Other: Referral to Psychiatry
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.
This option will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are found to be ineligible for intervention arms of the study, or those who are eligible for the intervention arm but decline to participate in the intervention.
Other: Survey only
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.
- Adherence to Intervention [ Time Frame: 12 weeks ]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)
- Accrual [ Time Frame: 12 weeks ]Percentage of patients screened for the trial who are eligible
- Retention [ Time Frame: 12 weeks ]Percentage of participants who complete the 12 week outcome assessment
- Efficacy - Change in Depression Symptoms [ Time Frame: 12 weeks ]12 weeks change in 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.
- Efficacy - Change in Anxiety Symptoms [ Time Frame: 12 weeks ]12 week change in 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03464383
|United States, North Carolina|
|Wake Forest Baptist Medical Center|
|Winston-Salem, North Carolina, United States, 27157|
|Principal Investigator:||Heidi Munger Clary, MD||Wake Forest University Health Sciences|