Safety and tolerability of oral loading divalproex sodium in acutely manic bipolar patients.

R. M. Hirschfeld, M. H. Allen, J. P. McEvoy, P. E. Keck, J. M. Russell

Research output: Contribution to journalArticle

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Abstract

BACKGROUND: Achieving therapeutic blood levels of a mood stabilizer as quickly as possible is desirable in patients with acute mania. We examined the feasibility and safety of an accelerated oral loading strategy (divalproex, 30 mg/kg/day, on days 1 and 2, followed by 20 mg/kg/day on days 3-10) designed to bring serum valproate concentrations to therapeutic levels (i.e., above 50 microg/mL). METHOD: Fifty-nine patients who met DSM-IV diagnostic criteria for current manic episode and who had a Mania Rating Scale score > or = 14 were randomly assigned on a double-blind basis to receive divalproex oral loading (N = 20); divalproex nonloading (N = 20) at a starting dose of 250 mg t.i.d. on days 1 and 2, followed by standard dose titration for days 3 to 10; or lithium carbonate (N = 19) at a starting dose of 300 mg t.i.d., followed by standard dose titration for days 3 to 10. RESULTS: Eighty-four percent of the divalproex-loading patients, but only 30% of the divalproex-nonloading patients, had valproate serum levels above 50 microg/mL at day 3 of the study. None of the lithium-treated patients had serum lithium levels above 0.8 mEq/L at study day 3. No patient was removed from the study because of an adverse event. There were no significant differences between the groups in the frequencies or types of adverse events. CONCLUSION: Accelerated oral loading with divalproex sodium is a feasible and safe method to bring serum valproate concentrations to effective levels rapidly.

Original languageEnglish (US)
Pages (from-to)815-818
Number of pages4
JournalThe Journal of clinical psychiatry
Volume60
Issue number12
StatePublished - Dec 1999

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Valproic Acid
Safety
Serum
Bipolar Disorder
Lithium
Lithium Carbonate
Diagnostic and Statistical Manual of Mental Disorders
Therapeutics

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Clinical Psychology

Cite this

Hirschfeld, R. M., Allen, M. H., McEvoy, J. P., Keck, P. E., & Russell, J. M. (1999). Safety and tolerability of oral loading divalproex sodium in acutely manic bipolar patients. The Journal of clinical psychiatry, 60(12), 815-818.

Safety and tolerability of oral loading divalproex sodium in acutely manic bipolar patients. / Hirschfeld, R. M.; Allen, M. H.; McEvoy, J. P.; Keck, P. E.; Russell, J. M.

In: The Journal of clinical psychiatry, Vol. 60, No. 12, 12.1999, p. 815-818.

Research output: Contribution to journalArticle

Hirschfeld, RM, Allen, MH, McEvoy, JP, Keck, PE & Russell, JM 1999, 'Safety and tolerability of oral loading divalproex sodium in acutely manic bipolar patients.', The Journal of clinical psychiatry, vol. 60, no. 12, pp. 815-818.
Hirschfeld RM, Allen MH, McEvoy JP, Keck PE, Russell JM. Safety and tolerability of oral loading divalproex sodium in acutely manic bipolar patients. The Journal of clinical psychiatry. 1999 Dec;60(12):815-818.
Hirschfeld, R. M. ; Allen, M. H. ; McEvoy, J. P. ; Keck, P. E. ; Russell, J. M. / Safety and tolerability of oral loading divalproex sodium in acutely manic bipolar patients. In: The Journal of clinical psychiatry. 1999 ; Vol. 60, No. 12. pp. 815-818.
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