Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
|ClinicalTrials.gov Identifier: NCT01309074|
Recruitment Status : 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.)
First Posted : March 4, 2011
Last Update Posted : December 7, 2012
|Condition or disease||Intervention/treatment||Phase|
|Epilepsy Anxiety||Drug: Pregabalin-Lyrica Drug: Sertraline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline|
|Study Start Date :||November 2009|
|Estimated Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
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.
- Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A. [ Time Frame: 27 weeks ]Change in severity of symptoms &/o remission of symptooms of anxiety between visit 0 & the end of treatment phase.
- Change in Quality of life measures assessed with the QOLIE-89. [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01309074
|United States, Illinois|
|Rush University Medical Center|
|Chicago, Illinois, United States, 60612|
|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.|