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

September 7, 2021 updated by: Rush University Medical Center
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
27 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
27 weeeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 2, 2011

First Submitted That Met QC Criteria

March 3, 2011

First Posted (Estimate)

March 4, 2011

Study Record Updates

Last Update Posted (Actual)

September 14, 2021

Last Update Submitted That Met QC Criteria

September 7, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA0082BY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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