Pilot comparison of extended-release and standard preparations of divalproex sodium in patients with bipolar and schizoaffective disorders.
OBJECTIVE
The authors compared the new extended-release and standard preparations of divalproex sodium.


METHODS
Twelve patients with DSM-IV bipolar disorder or schizoaffective disorder who were clinically stable while taking the standard form of divalproex participated in the study. These patients were given a single daily dose of the extended-release preparation of divalproex in an open 6-week trial. Clinical symptoms and adverse effects were rated weekly. Doses were adjusted to maintain steady serum valproate concentrations.


RESULTS
The medication change was associated with negligible changes in clinical status and tolerability. To maintain serum drug levels, however, 21% higher doses of the extended-release preparation were required.


CONCLUSIONS
Use of extended-release divalproex once a day was as well tolerated as the standard preparation, with no change in efficacy within 6 weeks, but the daily dose needed to maintain stable serum valproic acid concentration was 21% higher.
Centorrino
Franca
F
Department of Psychiatry, Harvard Medical School, Boston, USA. centorf@mcleanpo.mclean.org
Kelleher
James P
JP
Berry
Judith M
JM
Salvatore
Paola
P
Eakin
Marion
M
Fogarty
Kate V
KV
Fellman
Veronica
V
Baldessarini
Ross J
RJ
D000553:Ambulatory Care; D018692:Antimanic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000097:blood / Q000188:drug therapy*; D003692:Delayed-Action Preparations; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011618:Psychotic Disorders / Q000097:blood / Q000188:drug therapy*; D016896:Treatment Outcome; D014635:Valproic Acid / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use*
D018692:Antimanic Agents; D003692:Delayed-Action Preparations; D014635:Valproic Acid