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

Sponsor

Rush University Medical Center (Other)

Overall Status

Terminated

CT.gov ID

NCT01309074

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Epilepsy Anxiety	Drug: Pregabalin-Lyrica Drug: Sertraline	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Pregabalin-Lyrica Pregabalin in a dose up to 300mg/day in BID dosing. Other Names: Lyrica.
Active Comparator: 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.	Drug: Sertraline Sertraline in a dose up to 200mg/day in BID dosing. Other Names: Zoloft.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Pregabalin-Lyrica

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

Other Names:

Lyrica.

Active Comparator: 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.

Drug: Sertraline

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

Other Names:

Zoloft.

Outcome Measures

Primary Outcome Measures

Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A. [27 weeks]
Change in severity of symptoms &/o remission of symptooms of anxiety between visit 0 & the end of treatment phase.

Secondary Outcome Measures

Change in Quality of life measures assessed with the QOLIE-89. [27 weeeks.]
A change in the toatal 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612

Sponsors and Collaborators

Rush University Medical Center

Investigators

Principal Investigator: Andre M. Kanner, MD, Director Laboratory Encephalography, Associate Director Section of Epilepsy and Rush Epilepsy Center and Senior Attending Neurologist Rush University Medical Center.