Expired Study
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Chicago, Illinois 60612


Purpose:

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.


Criteria:

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.


Study is Available At:


Original ID:

GA0082BY


NCT ID:

NCT01309074


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Terminated


Study Phase:

Phase 4


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Rush University Medical Center


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:

Only two subjects were enrolled and complete


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Para


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

2


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andre M. Kanner, MD
Principal Investigator
Director Laboratory Encephalography, Associate Director Section of Epilepsy and Rush Epilepsy Center

Study Dates

Start Date:November 2009
Completion Date:December 2012
Completion Type:Actual
Primary Completion Date:December 2012
Primary Completion Type:Anticipated
Verification Date:December 2012
Last Changed Date:December 6, 2012
First Received Date:March 2, 2011

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in Quality of life measures assessed with the QOLIE-89.
Time Frame:27 weeeks.
Safety Issues:True
Description: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 trea
Outcome Type:Primary Outcome
Measure:Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.
Time Frame:27 weeks
Safety Issues:True
Description:Change in severity of symptoms &/o remission of symptooms of anxiety between visit 0 & the end of treatment phase.

Study Interventions

Intervention Type:Drug
Name:Pregabalin-Lyrica
Description:Pregabalin in a dose up to 300mg/day in BID dosing.
Arm Name:Pregabalin
Other Name:Lyrica.
Intervention Type:Drug
Name:Sertraline
Description:Sertraline in a dose up to 200mg/day in BID dosing.
Arm Name:Sertraline
Other Name:Zoloft.

Study Arms

Study Arm Type:Active Comparator
Arm Name:Sertraline
Description: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.
Study Arm Type:Experimental
Arm Name:Pregabalin
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Rush University Medical Center

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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