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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
  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.


Condition Intervention Phase
Epilepsy
Anxiety
Drug: Pregabalin-Lyrica
Drug: Sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Pregabalin Improve Symptoms of Anxiety in Patients With Epilepsy? A Comparison With Sertraline

Resource links provided by NLM:


Further study details as provided by Rush University Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 2
Study Start Date: November 2009
Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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.
Drug: Sertraline
Sertraline in a dose up to 200mg/day in BID dosing.
Other Name: Zoloft.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309074

Locations
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
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.
  More Information

No publications provided

Responsible Party: Andres M. Kanner, MD, M.D., Rush University Medical Center
ClinicalTrials.gov Identifier: NCT01309074     History of Changes
Other Study ID Numbers: GA0082BY
Study First Received: March 2, 2011
Last Updated: December 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Rush University Medical Center:
Anxiety
Epilepsy

Additional relevant MeSH terms:
Anxiety Disorders
Epilepsy
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Nervous System Diseases
Pregabalin
Sertraline
Analgesics
Anticonvulsants
Antidepressive Agents
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014