Levetiracetam in the Treatment of Acute Mania: An Open Add-On Study With an On-Off-On Design
J Clin Psychiatry 2003;64(7):781-784
© Copyright 2015 Physicians Postgraduate Press, Inc.
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Background: Levetiracetam is a novel
antiepileptic drug with a broad spectrum of efficacy in epilepsy.
We have tested the antimanic properties of the drug as an add-on
to haloperidol in an open trial.
Method: After giving informed written
consent, 10 bipolar I acutely manic (DSM-IV) inpatients were
investigated in an on-off-on study design. All patients were
treated with 5 to 10 mg/day of haloperidol, depending on
tolerability, throughout the investigation. Levetiracetam (up to
4000 mg/day) was added until day 14, then discontinued and
reintroduced at day 21. The psychopathologic changes were
assessed with the Young Mania Rating Scale (YMRS).
Results: After a mean decrease of the YMRS
scores from 29.6 to 17.2 during the first "on" phase,
manic symptoms worsened during the "off" period (YMRS
score 20.9) and ameliorated again during the second
"on" phase, with a decrease of the mean YMRS score to
14.7 at the end of the study. The mean dose of levetiracetam was
3125 mg/day. At day 14, only 2 (20%) of 10 patients were
responders (defined as a decrease in YMRS scores of 50%) compared
with 7 (70%) of 10 responders at the end of the study at day 28.
Conclusion: The results from this open on-off-on
add-on study suggest that levetiracetam exhibited additional
antimanic effects. Controlled studies are clearly required.