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

Primary Purpose

Epilepsy, Anxiety

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Pregabalin-Lyrica
Sertraline
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Epilepsy focused on measuring Anxiety, Epilepsy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pregabalin

Sertraline

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in Quality of life measures assessed with the QOLIE-89.
A change in the total 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.

Full Information

First Posted
March 2, 2011
Last Updated
January 31, 2023
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01309074
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No subjects could be enrolled and therefore we decided to withdraw/stop the study.
Study Start Date
November 2009 (Actual)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Patients with epilepsy will be treated with either sertraline (up to a dose of 200mg/day) or pregabalin (up to a dose of 300mg/day) for the treatment of symptoms of anxiety. Outcome measures will include changes in the anxiety severity scales.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Anxiety
Keywords
Anxiety, Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pregabalin
Arm Type
Experimental
Arm 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.
Arm Title
Sertraline
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Pregabalin-Lyrica
Other Intervention Name(s)
Lyrica.
Intervention Description
Pregabalin in a dose up to 300mg/day in BID dosing.
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Zoloft.
Intervention Description
Sertraline in a dose up to 200mg/day in BID dosing.
Primary Outcome Measure Information:
Title
Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.
Description
Change in severity of symptoms &/o remission of symptoms of anxiety between visit 0 & the end of treatment phase.
Time Frame
27 weeks
Secondary Outcome Measure Information:
Title
Change in Quality of life measures assessed with the QOLIE-89.
Description
A change in the total 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.
Time Frame
27 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre M. Kanner, MD
Organizational Affiliation
Director Laboratory Encephalography
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

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

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