Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
This study has been terminated.
(Only two subjects were enrolled and completed the trial and enrollment of additional subjects was too slow. Accordingly, it was decided to terminate the study.)
Rush University Medical Center
Information provided by (Responsible Party):
Andres M. Kanner, MD, Rush University Medical Center
First received: March 2, 2011
Last updated: December 6, 2012
Last verified: December 2012
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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Rush University Medical Center:
Primary Outcome Measures:
- Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A. [ Time Frame: 27 weeks ] [ Designated as safety issue: Yes ]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. [ Time Frame: 27 weeeks. ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2009|
|Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
Pregabalin in a dose up to 300mg/day in BID dosing.
Other Name: 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.
Sertraline in a dose up to 200mg/day in BID dosing.
Other Name: Zoloft.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309074
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
Sponsors and Collaborators
Rush University Medical Center
|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.|