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

Rush

Status and phase: Withdrawn; Phase 4

Conditions: Epilepsy; Anxiety

Treatments: Drug: Sertraline; Drug: Pregabalin-Lyrica

Study type: Interventional

Funder types: Other

Identifiers

NCT01309074

GA0082BY

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Pregabalin

Experimental group

Description:

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.

Treatment:

Drug: Pregabalin-Lyrica

Sertraline

Active Comparator group

Description:

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.

Treatment:

Drug: Sertraline