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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01309074

Enrollment

Registered

2011-03-04

Start date

2009-11-30

Completion date

2012-12-31

Last updated

2023-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Epilepsy

Keywords

Anxiety, Epilepsy

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.

Interventions

DRUGPregabalin-Lyrica

Pregabalin in a dose up to 300mg/day in BID dosing.

DRUGSertraline

Sertraline in a dose up to 200mg/day in BID dosing.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026