Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline

Study Overview
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Brief Summary
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The aim of the study is to compare the safety & efficacy of sertraline (up to a dose of 200mg/day) & pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety in patients with epilepsy.

Detailed Description
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Patients with epilepsy will be treated with either sertraline (up to a dose of 200mg/day) or pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety. Outcome measures will include changes in the anxiety severity scales.

Official Title
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Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline

Conditions
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Epilepsy, Anxiety

Intervention / Treatment
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* Drug: Pregabalin-Lyrica
* Drug: Sertraline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: GAD-7 total score above 10. Have a diagnosis of a Partial Seizure Disorder. Have a Hamilton-A total score 20 and above. 18-80 years of age. Able to read at a fourth grade level. If a woman of childbearing age, agrees to use an acceptable means of birth control. Exclusion Criteria: Unable to understand and sign a consent. Unable to follow instructions for the study. Displaying current suicidal ideation Having psychogenic non-epileptic seizures Have a history of drug or alcohol abuse. Use of any investigational drug within the last 30 days. Hypersensitivity reaction or other serious adverse event to PGB in prior trials.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pregabalin<br>Pregabalin is an antiepileptic medication which has been found in double blind placebo controlled trials to be effective and safe in the treatment of primary generalized anxiety disorder. It has an indication for the treatment of this condition in Europe & Canada but not in the US. | Drug: Pregabalin-Lyrica<br>* Pregabalin in a dose up to 300mg/day in BID dosing.<br>* Other names: Lyrica.;|
| Active Comparator: Sertraline<br>Sertraline is an SSRI found to be an effective treatment of generalized anxiety disorder in controlled trials. It does not have an indication for this in this country. | Drug: Sertraline<br>* Sertraline in a dose up to 200mg/day in BID dosing.<br>* Other names: Zoloft.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A. | Change in severity of symptoms &/o remission of symptoms of anxiety between visit 0 & the end of treatment phase. | 27 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of life measures assessed with the QOLIE-89. | A change in the total scores of the QOLIE-89 scores as well as in the individual subscales and change in the tolerance of antiepileptic medication assessed with change in the total score of the adverse event profile between baseline & the end of treatment phase. | 27 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety, Epilepsy