Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Email this article to a Colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My Articles & Searches Download to citation manager Citing Articles via HighWire Citing Articles via Google Scholar Articles by Keck, P. E. Articles by the Ziprasidone in Mania Study Group Search for Related Content PubMed Citation Articles by Keck, P. E., Jr. Articles by the Ziprasidone in Mania Study Group, Bipolar Disorder Atypical Neuroleptics

Ziprasidone in the Treatment of Acute Bipolar Mania: A Three-Week, Placebo-Controlled, Double-Blind, Randomized Trial

OBJECTIVE: The study evaluated the efficacy and tolerability of ziprasidone, compared with placebo, in the treatment of adult patients with acute bipolar mania. METHOD: Patients with a primary DSM-IV diagnosis of bipolar I disorder and a current manic or mixed episode (confirmed by the Structured Clinical Interview for DSM-IV Axis I Disorders, Patient Edition) (N=210) were randomly assigned in a 2:1 ratio to 3 weeks of double-blind treatment with ziprasidone (40–80 mg twice daily) or placebo. Efficacy was assessed with the Schedule for Affective Disorders and Schizophrenia, Change Version (which contains the Mania Rating Scale), Positive and Negative Syndrome Scale, Clinical Global Impression (CGI) severity scale, CGI improvement scale, and Global Assessment of Functioning Scale. Primary efficacy variables were differences from baseline to endpoint (last observation carried forward) in mean Mania Rating Scale and CGI severity scale scores between the ziprasidone and placebo groups. Safety evaluations included monitoring of adverse events, vital signs, electrocardiogram results, and clinical laboratory values and assessment of movement disorders and akathisia. RESULTS: Ziprasidone produced rapid, sustained improvements relative to baseline and placebo on all primary and most secondary efficacy measures at endpoint. Significant improvements were typically observed within 2 days after treatment commenced and were maintained throughout the 3 weeks. Ziprasidone was well tolerated and associated with a low rate of extrapyramidal symptoms; neither weight gain nor clinically significant changes in vital signs or other safety parameters were observed with ziprasidone. CONCLUSIONS: Ziprasidone monotherapy was significantly superior to placebo in reducing symptoms of acute mania in patients with bipolar I disorder. Onset of action was rapid, and tolerability of ziprasidone was generally comparable to that of placebo.

This article has been cited by other articles:

				K. Aitchison, M Bienroth, J Cookson, R Gray, P. Haddad, B Moore, L Ratna, G Sullivan, D Taylor, M Taylor, et al. A UK consensus on the administration of aripiprazole for the treatment of mania J Psychopharmacol, May 1, 2009; 23(3): 231 - 240. [Abstract] [PDF]

				G. L. Jensen Drug-Induced Hyperphagia: What Can We Learn From Psychiatric Medications? JPEN J Parenter Enteral Nutr, September 1, 2008; 32(5): 578 - 581. [Abstract] [Full Text] [PDF]

				H. Scherk, F. G. Pajonk, and S. Leucht Second-Generation Antipsychotic Agents in the Treatment of Acute Mania: A Systematic Review and Meta-analysis of Randomized Controlled Trials Arch Gen Psychiatry, April 1, 2007; 64(4): 442 - 455. [Abstract] [Full Text] [PDF]

				R. M. A. Hirschfeld Guideline Watch (November 2005): Practice Guideline for the Treatment of Patients with Bipolar Disorder, 2nd Edition Focus, January 1, 2007; 5(1): 34 - 39. [Abstract] [Full Text] [PDF]

				Bibliography BIPOLAR DISORDER Focus, January 1, 2007; 5(1): 40 - 43. [Full Text] [PDF]

				G. Sachs, R. Sanchez, R. Marcus, E. Stock, R. Mcquade, W. Carson, N. Abou-Gharbia, C. Impellizzeri, S. Kaplita, L. Rollin, et al. Aripiprazole in the treatment of acute manic or mixed episodes in patients with bipolar I disorder: a 3-week placebo-controlled study J Psychopharmacol, July 1, 2006; 20(4): 536 - 546. [Abstract] [PDF]

				M. Tohen, J. R. Calabrese, G. S. Sachs, M. D. Banov, H. C. Detke, R. Risser, R. W. Baker, J. C.-Y. Chou, and C. L. Bowden Randomized, Placebo-Controlled Trial of Olanzapine as Maintenance Therapy in Patients With Bipolar I Disorder Responding to Acute Treatment With Olanzapine Am J Psychiatry, February 1, 2006; 163(2): 247 - 256. [Abstract] [Full Text] [PDF]

				P. A Marken and R. W Pies Emerging Treatments for Bipolar Disorder: Safety and Adverse Effect Profiles Ann. Pharmacother., February 1, 2006; 40(2): 276 - 285. [Abstract] [Full Text] [PDF]

				Drug treatments for bipolar disorder: 1 - Acute manic or depressive DTB, April 1, 2005; 43(4): 28 - 32. [Abstract] [Full Text] [PDF]

				K. R. R. Krishnan Psychiatric and Medical Comorbidities of Bipolar Disorder Psychosom Med, January 1, 2005; 67(1): 1 - 8. [Abstract] [Full Text] [PDF]

				D. E. ROSS Ziprasidone and Mania Am J Psychiatry, August 1, 2004; 161(8): 1503 - 1503. [Full Text] [PDF]

				W. O. Cooper, G. B. Hickson, C. Fuchs, P. G. Arbogast, and W. A. Ray New Users of Antipsychotic Medications Among Children Enrolled in TennCare Arch Pediatr Adolesc Med, August 1, 2004; 158(8): 753 - 759. [Abstract] [Full Text] [PDF]

				R. M.A. Hirschfeld, P. E. Keck Jr., M. Kramer, K. Karcher, C. Canuso, M. Eerdekens, and F. Grossman Rapid Antimanic Effect of Risperidone Monotherapy: A 3-Week Multicenter, Double-Blind, Placebo-Controlled Trial Am J Psychiatry, June 1, 2004; 161(6): 1057 - 1065. [Abstract] [Full Text] [PDF]

				M. Tohen, J. F. Goldberg, A. M. Gonzalez-Pinto Arrillaga, J. M. Azorin, E. Vieta, M.-C. Hardy-Bayle, W. B. Lawson, R. A. Emsley, F. Zhang, R. W. Baker, et al. A 12-Week, Double-blind Comparison of Olanzapine vs Haloperidol in the Treatment of Acute Mania Arch Gen Psychiatry, December 1, 2003; 60(12): 1218 - 1226. [Abstract] [Full Text] [PDF]

				P. E. Keck Jr., R. Marcus, S. Tourkodimitris, M. Ali, A. Liebeskind, A. Saha, G. Ingenito, and the Aripiprazole Study Group A Placebo-Controlled, Double-Blind Study of the Efficacy and Safety of Aripiprazole in Patients With Acute Bipolar Mania Am J Psychiatry, September 1, 2003; 160(9): 1651 - 1658. [Abstract] [Full Text] [PDF]

				J. Rosack Psychiatr News, May 16, 2003; 38(10): 46 - 47. [Full Text]

Get information about faster international access.

Privacy Policy

Copyright © 2003 American Psychiatric Association. All rights reserved.

Home | Search | Current Issue | Past Issues | Subscribe | All APPI Journals | Help | Contact Us