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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.)
Sponsor:
Information provided by (Responsible Party):
Andres M. Kanner, MD, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT01309074
First received: March 2, 2011
Last updated: December 6, 2012
Last verified: December 2012

March 2, 2011
December 6, 2012
November 2009
December 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01309074 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline
Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Epilepsy
  • Anxiety
  • Drug: Pregabalin-Lyrica
    Pregabalin in a dose up to 300mg/day in BID dosing.
    Other Name: Lyrica.
  • Drug: Sertraline
    Sertraline in a dose up to 200mg/day in BID dosing.
    Other Name: Zoloft.
  • 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.
    Intervention: Drug: Pregabalin-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.
    Intervention: Drug: Sertraline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
December 2012
December 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01309074
GA0082BY
No
Andres M. Kanner, MD, Rush University Medical Center
Rush University Medical Center
Not Provided
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.
Rush University Medical Center
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP