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Symptomatic Remission in Patients with Bipolar Mania: Results from a Double-Blind, Placebo-Controlled Trial of Risperidone Monotherapy

Published online by Cambridge University Press:  05 March 2007

Srihari Gopal
Affiliation:
Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ, USA; E-mail: SGopal2@PRDUS.JNJ.com
John L. Beyer
Affiliation:
Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA; E-mail: beyer001@mc.duke.edu
David C. Steffens
Affiliation:
Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA; E-mail: steff001@mc.duke.due
Michelle L. Kramer
Affiliation:
Johnson & Johnson Pharmaceutical Research and Development, LLC, Titusville, NJ, USA; E-mail: mkramer@prdus.jnj.com

Extract

ABSTRACT

Background: The purpose of this analysis was to compare symptomatic remission rates between risperidone and placebo in a completed randomized controlled trial. Design and Methods: Two hundred ninety (290) adult patients who met DSM-IV criteria for Bipolar I Disorder Manic or Mixed episode were randomized to flexible doses of risperidone or placebo for 3 weeks. An entry Young Mania Rating Scale (YMRS) score of > 20 was required at trial screening and baseline. Time to first onset of remission (as defined as a YMRS score of < 8) was assessed using Cox proportional hazards. Persence or absence of sustained remission was analyzed using logistic regression. Sustained remission was defined as maintaining a YMRS < 8 for the remainder of the trial or until censor. Results: After adjusting for presence of psychosis, baseline YMRS, gender, number of mood cycles in the previous year and treatment,the odds of sustained remission for subjects on risperidone was 5.6 (p < 0.0001). Similarly the adjusted hazard or remission for subjects on rsiperidone was 4.0 (p < 0.0001). Interpretaion: A statistically significant proportion of manic patients receiving risperidone monotherapy achieved symptomatic remission within 3 weeks as compared to placebo.

Type
Review Article
Copyright
© 2007 Cambridge University Press

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References

American Psychiatric Association (2000). Diagnostic and Statistical Manual of Mental Disorders (4th ed. – Text Revision). Washington, DC: American Psychiatric Association, p. 382.
American Psychiatric Association (2002). Practice guideline for the treatment of patients with bipolar disorder (revision). American Journal of Psychiatry, 159 (Suppl. 4), 150.
Angst, J., & Sellaro, R. (2000). Historical perspectives and natural history of bipolar disorder. Biological Psychiatry, 48 (6), 445457.CrossRefGoogle Scholar
Bowden, C.L., Grunze, H., Mullen, J., Brecher, M., Paulsson, B., Jones, M., Vagero, M., & Svensson, K. (2005). A randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder. Journal of Clinical Psychiatry, 66 (1), 111121.CrossRefGoogle Scholar
Chengappa, K.N., Hennen, J., Baldessarini, R.J., Kupfer, D.J., Yatham, L.N., Gershon, S., Baker, R.W., & Tohen, M. (2005). Recovery and functional outcomes following olanzapine treatment for bipolar I mania. Bipolar Disorder, 7 (1), 6876.CrossRefGoogle Scholar
Fleiss, J.L., et al. (1976). The life table. A method for analyzing longitudinal studies. Archives of General Psychiatry, 33 (1), 107112.CrossRefGoogle Scholar
Frank, E. et al. (1991). Conceptualisation and rationale for consensus definitions of terms in major depressive disorder. Remission, recovery, relapse, and recurrence. Archives of General Psychiatry, 48, 851855Google Scholar
Gelenberg, A.J., et al. (1996). Antipyschotics in bipolar disorder. Journal of Clinical Psychiatry, 57 (Suppl. 9), 4952.Google Scholar
Goodwin, F.K., & Jamison, K.R. (1990). Manic Depressive Illness (1st ed.). New York: Oxford University Press; pp. 15.
Gopal, S., Steffens, D.C., Kramer, M.L., & Olsen, M.K. (2005). Symptomatic remission in patients with bipolar mania: results from a double-blind, placebo-controlled trial of risperidone monotherapy. Journal of Clinical Psychiatry, 66 (8), 10161020.CrossRefGoogle Scholar
Hirschfeld, R.M., Keck, Jr. P.E., Kramer, M., Karcher, K., Canuso, C., Eerdekens, M., & Grossman, F. (2004). Rapid antimanic effect of risperidone monotherapy: a 3-week multicenter, double-blind, placebo-controlled trial. American Journal of Psychiatry, 161 (6), 10571065.CrossRefGoogle Scholar
Judd, L.L., et al. (1998). A prospective 12-year study of subsyndromal and syndromal depressive symptoms in unipolar major depressive disorders 1998. Archives of General Psychiatry, 55, 694700.CrossRefGoogle Scholar
Khanna, S., Vieta, E., Lyons, B., Grossman, F., Eerdekens, M., & Kramer, M. (2005). Risperidone in the treatment of acute mania. Double-blind placebo-controlled study. British Journal of Psychiatry, 187, 229234.CrossRefGoogle Scholar
McIntyre, R.S., Brecher, M., Paulsson, B., Huizar, K., & Mullen, J. (2005). Quetiapine or haloperidol as monotherapy for bipolar mania – a 12-week, double-blind, randomised, parallel-group, placebo-controlled trial. European Neuropsychopharmacology, 15 (5), 573585.CrossRefGoogle Scholar
Perlis, R.H., Ostacher, M.J., Patel, J.K., Marangell, L.B., Zhang, H., Wisniewski, S.R., Ketter, T.A., Miklowitz, D.J., Otto, M.W., Gyulai, L., Reilly-Harrington, N.A., Nierenberg, A.A., Sachs, G.S., & Thase, M.E. (2006). Predictors of recurrence in bipolar disorder: primary outcomes from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). American Journal of Psychiatry, 163 (2), 217224.CrossRefGoogle Scholar
Potkin, S.G., Keck, Jr. P.E., Segal, S., Ice, K., & English, P. (2005). Ziprasidone in acute bipolar mania: a 21-day randomized, double-blind, placebo-controlled replication trial. Journal of Clinical Psychopharmacology, 25 (4), 301310.CrossRefGoogle Scholar
Roy-Byrne, P.P., et al. (1988). Suicide and course of illness in major affective disorder. Journal of Affective Disorders, 15, 18.CrossRefGoogle Scholar
Sachs, G.S., Grossman, F., Ghaemi, S.N., Okamoto, A., & Bowden, C.L. (2002). Combination of a mood stabilizer with risperidone or haloperidol for treatment of acute mania: a double-blind, placebo-controlled comparison of efficacy and safety. American Journal of Psychiatry, 159 (7), 11461154.CrossRefGoogle Scholar
Smulevich, A.B., Khanna, S., Eerdekens, M., Karcher, K., Kramer, M., & Grossman, F. (2005). Acute and continuation risperidone monotherapy in bipolar mania: a 3-week placebo-controlled trial followed by a 9-week double-blind trial of risperidone and haloperidol. European Neuropsychopharmacology, 15 (1), 7584.CrossRefGoogle Scholar
Tohen, M., Jacobs, T.G., Grundy, S.L., McElroy, S.L., Banov, M.C., Janicak, P.G., Sanger, T., Risser, R., Zhang, F., Toma, V., Francis, J., Tollefson, G.D., & Breier, A. (2000). Efficacy of olanzapine in acute bipolar mania: a double-blind, placebo-controlled study. The Olanzipine HGGW Study Group. Archives of General Psychiatry, 57 (9), 841849.CrossRefGoogle Scholar
Weissman, M.M., et al. (1990). Affective disorders. In: Robins, L.R.D. (ed.), Psychiatric Disorders of America: The Epidemiologic Catchment Area Study. New York, NY: Free Press, pp. 5880.
Yatham, L.N., Grossman, F., Augustyns, I., Vieta, E., & Ravindran, A. (2003). Mood stabilisers plus risperidone or placebo in the treatment of acute mania. International, double-blind, randomised controlled trial. British Journal of Psychiatry, 182, 141147.CrossRefGoogle Scholar

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Symptomatic Remission in Patients with Bipolar Mania: Results from a Double-Blind, Placebo-Controlled Trial of Risperidone Monotherapy
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