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

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Pregabalin; Sertraline

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.