Pilot Study of Levetiracetam (Keppra® (Registered Trademark)) for Bipolar Illness
Status:
Completed
Trial end date:
2003-04-01
Target enrollment:
Participant gender:
Summary
This study will explore the possible effectiveness of levetiracetam in patients with bipolar
illness who have not responded adequately to standard treatments. Levetiracetam was recently
approved to treat seizures. Other drugs in the same class as levetiracetam, including
carbamazepine and valproate, are widely recognized as substitute medications for lithium or
are used as an adjunct to it, and other anticonvulsants have also shown promise in improving
bipolar symptoms.
Patients with bipolar illness whose manic, depressed or unstable moods are not adequately
controlled by their current treatment and who have not responded previously to two standard
treatments (i.e., lithium, valproate, carbamazepine or neuroleptics) may be eligible for this
study.
Participants will take levetiracetam starting at 500 mg daily. If this dose is well
tolerated, it will be increased to 500 mg twice a day. Every 3 days, doses may be increased
until the target dose of 3000 mg/day is reached. Higher doses, not to exceed 4000 mg/day, may
be tried in patients who do not respond fully to the lower doses. Patients and observers will
use standard ratings to evaluate the patients' response to therapy during the 8-week study.
If, after 8 weeks, the results appear promising, patients may continue treatment for an
additional 6 months to evaluate longer-term effects.