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

Phase 4

Withdrawn

• Conditions: Epilepsy; Anxiety
• Interventions: Drug: Pregabalin-Lyrica; Drug: Sertraline

• Registration Number: NCT01309074
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-03-02
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-04
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-31
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pregabalin	Pregabalin-Lyrica	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	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.

Primary Outcome Measures

Name	Time	Method
Improvement of anxiety symptoms measured with the changes of the total scores of GAD-7 & HAM-A.	27 weeks	Change in severity of symptoms \&/o remission of symptoms of anxiety between visit 0 \& the end of treatment phase.

Secondary Outcome Measures

Name	Time	Method
Change in Quality of life measures assessed with the QOLIE-89.	27 weeks.	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.

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States