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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-12-31

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.

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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.

Conditions

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Epilepsy Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Pregabalin

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.

Group Type EXPERIMENTAL

Pregabalin-Lyrica

Intervention Type DRUG

Pregabalin in a dose up to 300mg/day in BID dosing.

Sertraline

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.

Group Type ACTIVE_COMPARATOR

Sertraline

Intervention Type DRUG

Sertraline in a dose up to 200mg/day in BID dosing.

Interventions

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Pregabalin-Lyrica

Pregabalin in a dose up to 300mg/day in BID dosing.

Intervention Type DRUG

Sertraline

Sertraline in a dose up to 200mg/day in BID dosing.

Intervention Type DRUG

Other Intervention Names

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Lyrica. Zoloft.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No