A Phase 4 interventional study of Pregabalin-Lyrica and Sertraline in Epilepsy and Anxiety, sponsored by Rush University Medical Center. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-02-02.
Sponsored by Rush University Medical Center · Phase 4, Interventional, and Treatment
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.
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.
1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.
Browse Epilepsy studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Pregabalin-Lyrica
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.
Drug: Sertraline
Pregabalin in a dose up to 300mg/day in BID dosing.
Also known as: Lyrica.
Sertraline in a dose up to 200mg/day in BID dosing.
Also known as: Zoloft.
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.
Time frame: 27 weeks
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.
Time frame: 27 weeks.
This study is withdrawn, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rush University Medical Center