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Comparative efficacy and safety of oxcarbazepine versus divalproex sodium in the treatment of acute mania: A pilot study

Published online by Cambridge University Press:  16 April 2020

Ashish Kumar Kakkar ,
H.S. Rehan ,
K.E.S. Unni ,
Neeraj Kumar Gupta ,
Deepti Chopra  and
Dinesh Kataria
Ashish Kumar Kakkar
Affiliation:
Department of Pharmacology, Lady Hardinge Medical College and SSK Hospital, Connaught Place, New Delhi110001, India
H.S. Rehan
Affiliation:
Department of Pharmacology, Lady Hardinge Medical College and SSK Hospital, Connaught Place, New Delhi110001, India
K.E.S. Unni
Affiliation:
Department of Psychiatry and Drug De-addiction Centre, Lady Hardinge Medical College and SSK Hospital, New Delhi110001, India
Neeraj Kumar Gupta
Affiliation:
Department of Psychiatry and Drug De-addiction Centre, Lady Hardinge Medical College and SSK Hospital, New Delhi110001, India
Deepti Chopra*
Affiliation:
Department of Pharmacology, Lady Hardinge Medical College and SSK Hospital, Connaught Place, New Delhi110001, India
Dinesh Kataria
Affiliation:
Department of Psychiatry and Drug De-addiction Centre, Lady Hardinge Medical College and SSK Hospital, New Delhi110001, India
*
*Corresponding author. Tel.: +91 9818710237. E-mail address: drdeeptichopra@yahoo.co.in (D. Chopra).
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Abstract

Objective

This study compared the efficacy and safety of oxcarbazepine and divalproex sodium in acute mania patients.

Subjects and methods

In this 12 week, randomized, double-blind pilot study, 60 patients diagnosed with acute mania (DSM-IV) and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexibly dosed oxcarbazepine (1000–2400 mg/day) or divalproex (750–2000 mg/day). The mean decrease in the YMRS score from baseline was used as the main outcome measure of response to treatment. A priori protocol-defined threshold scores were ≤12 for remission and ≥15 for relapse. Number of patients showing adequate response and the time taken to achieve improvement was compared. Adverse events were systematically recorded throughout the study.

Results

Over 12 weeks, mean improvement in YMRS scores was comparable for both the groups including the mean total scores as well as percentage fall from baseline. There were no significant differences between treatments in the rates of symptomatic mania remission (90% in divalproex and 80% in oxcarbazepine group) and subsequent relapse. Median time taken to symptomatic remission was 56 days in divalproex group while it was 70 days in the oxcarbazepine group (p = 0.123). A significantly greater number of patients in divalproex group experienced one or more adverse drug events as compared to patients in the oxcarbazepine group (66.7% versus 30%, p < 0.01).

Conclusion

Oxcarbazepine demonstrated comparable efficacy to divalproex sodium in the management of acute mania. Also the overall adverse event profile was found to be superior for oxcarbazepine.

Keywords

OxcarbazepineDivalproexAcute mania
Type
Original article
Information
European Psychiatry , Volume 24 , Issue 3 , April 2009 , pp. 178 - 182
Copyright
Copyright © Elsevier Masson SAS 2009

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References

Bowden, C.L., Singh, V.Valproate in bipolar disorder: 2000 onwards. Acta Psychiatr Scand 2005;111:S13–S20CrossRefGoogle Scholar
Cabrera, J.F., Muhlbauer, H.D., Schley, J., Stoll, K.D., Muller-Oerlinghausen, B.Long-term randomized clinical trial of oxcarbazepine vs. lithium in bipolar and schizoaffective disorder: preliminary results. Pharmacopsychiatry 1986;19:282–283CrossRefGoogle Scholar
Emrich, H.M.Studies with oxcarbazepine (Trileptal) in acute mania. Int Clin Psychopharmacol 1990;5:83–88Google Scholar
Emrich, H.M., Altman, H., Dose, M., Von Zerssen, D.Therapeutic effects of GABA-ergic drugs in affective disorder. A preliminary report. Pharmacol Biochem Behav 1983;19:369–372CrossRefGoogle ScholarPubMed
Emrich, H.M., Dose, M., Von Zerssen, D.The use of sodium valproate, carbamazepine, and oxcarbazepine in patients with affective disorders. J Affect Disord 1985;8:243–250CrossRefGoogle ScholarPubMed
Ghaemi, S.N., Berv, D.A., Klugman, J., Rosenquist, K.J., Hsu, D.J.Oxcarbazepine treatment of bipolar disorder. J Clin Psychiatry 2003;64:943–945CrossRefGoogle ScholarPubMed
Goodwin, F.K., Jamison, K.R.Manic-depressive illness New YorkOxford University Press 1990Google Scholar
Maj, M., Pirozzi, R., Kemali, D.Long term outcome of lithium prophylaxis in patients initially classified as complete responders. Psychopharmacology 1989;98:535–538CrossRefGoogle ScholarPubMed
Müller, A.A., Stoll, K.D.Carbamazepine and oxcarbazepine in the treatment of manic syndromes: studies in GermanyEmrich, H.M., Okuma, T., Müller, A.A.Anticonvulsants in affective disorders AmsterdamExcerpta Medica 1984 139–147Google Scholar
Naranjo, C.A., Busto, U., Sellers, E.M., Sandor, P., Ruiz, I., Roberts, E.A.et al.A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981;30:239–245CrossRefGoogle ScholarPubMed
Nasr, S.Oxcarbazepine for mood disorders. Am J Psychiatry 2002;159:1793CrossRefGoogle ScholarPubMed
Pope, H.G., McElroy, S.L., Keck, P.E., Hudson, J.I.Valproate in the treatment of acute mania. A placebo-controlled study. Arch Gen Psychiatry 1991;48:62–68CrossRefGoogle Scholar
Post, R.M., Altshuler, L.L.Mood disorders: treatment of bipolar disordersSadock, B.J., Sadock, V.A.Kaplan and Sadock’s comprehensive textbook of psychiatry 8th ed.Philadelphia, USALippincott William and Wilkins 2005 1661–1707Google Scholar
Reinstein, M.J., Sonnenberg, J.G., Hedberg, T.G., Jones, L.E., Reyngold, P.Oxcarbazepine versus divalproex sodium for the continuing treatment of mania. Clin Drug Invest 2003;23:671–677CrossRefGoogle ScholarPubMed
Tohen, M., Ketter, T.A., Zarate, C.A., Suppes, T., Frye, M., Altshuler, L.et al.Olanzapine versus divalproex sodium for the treatment of acute mania and maintenance of remission: a 47-week study. Am J Psychiatry 2003;160:1263–1271CrossRefGoogle ScholarPubMed
Velikonja, M.H.K.Effect of oxcarbazepine (GP 47.680) on affective and schizoaffective symptoms: a preliminary reportOkuma, T., Emrich, H.M., Muller, A.A.Anticonvulsants in affective disorders AmsterdamExcerpta Medica 1984 208–210Google Scholar
Weissman, M.M., Bland, R.C., Canino, G.J., Faravelli, C., Greenwald, S., Hwu, H.G.Crossnational epidemiology of major depression and bipolar disorder. JAMA 1996;276:293–299CrossRefGoogle Scholar
Yatham, L.N.Newer anticonvulsants in the treatment of bipolar disorder. J Clin Psychiatry 2004;65:S28–S35Google ScholarPubMed
Young, R.C., Biggs, J.J., Zeigler, V.E., Meyer, D.A.A rating scale for mania – reliability, validity and sensitivity. Br J Psychiatry 1978;133:429–435CrossRefGoogle ScholarPubMed
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