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

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01309074
• Other study ID #: GA0082BY
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 2009
• Est. completion date: December 2012

Study information

• Verified date: January 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Epilepsy

Intervention

Drug:
• Pregabalin-Lyrica
Pregabalin in a dose up to 300mg/day in BID dosing.
• Sertraline
Sertraline in a dose up to 200mg/day in BID dosing.

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	27 weeks
Secondary	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.	27 weeks.