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Am J Psychiatry 1996; 153:765-770
Copyright © 1996 by American Psychiatric Association
Relation of serum valproate concentration to response in mania
CL Bowden, PG Janicak, P Orsulak, AC Swann, JM Davis, JR Calabrese, P Goodnick, JG Small, AJ Rush, SE Kimmel, SC Risch and DD Morris
Department of Psychiatry, University of Texas Health Science Center, San Antonio 78284-7792, USA.
OBJECTIVE: This study was designed to determine the relation of valproate
serum levels to clinical improvement and development of adverse effects in
hospitalized patients with acute mania. The initial fixed-dose escalation
design, the monotherapy with divalproex, and the control of variables that
is possible only with hospitalized patients reduced the confounding factors
present in most outpatient studies of serum level-response relationships.
METHOD: Sixty-five hospitalized patients who met the Research Diagnostic
Criteria for bipolar disorder with mania were treated with divalproex, 750
mg/day for 2 days and then 1,000 mg/day on days 3-5; the dosage was
subsequently adjusted as clinically indicated for the remainder of the
21-day study. Manic symptoms were assessed with the Mania Rating Scale,
which is derived from the Schedule for Affective Disorders and
Schizophrenia. RESULTS: At day 5, patients with serum valproate levels >
or = 45 micrograms/ml were two to seven times as likely as patients with
levels < 45 micrograms/ml to show 20% or greater improvement in scores
on the manic syndrome subscale, the behavior and ideation subscale,
elevated mood, increased activity, motor hyperactivity, and psychosis.
Endpoint analyses yielded similar results. Adverse experiences
characteristic of divalproex treatment were disproportionately associated
with serum levels > or = 125 micrograms/ml. CONCLUSIONS: Acutely manic
patients treated with divalproex who have valproate serum levels between 45
and 100-125 micrograms/ml are much more likely to have efficacious and
well- tolerated responses than patients with lower or higher levels of
valproate.
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