Hostname: page-component-cd9895bd7-p9bg8 Total loading time: 0 Render date: 2024-12-25T19:34:56.749Z Has data issue: false hasContentIssue false

Studies of Carbamazepine Extended-Release Capsules in Bipolar Disorder

Published online by Cambridge University Press:  08 April 2017

Extract

This discussion reviews data from two 3-week, double-blind, placebo-controlled pivotal trials of carbamazepine extended release capsules (CBZ ERC; SPD417.301 and SPD417.304); pooled results from these trials; data from a 3-week, double-blind, placebo-controlled trial in lithium non-responders or non-tolerators (SPD417.302); and additional supportive data from a 6-month, open-label, extension trial (SPD417.303). In addition, information on a retrospective chart review of 600 adolescent and adult bipolar patients on CBZ ERC is presented.

In the first large double-blind, placebo-controlled study assessing CBZ ERC in acute mania, manic and mixed bipolar patients from multiple centers were hospitalized and all medications were discontinued. After reaching a stable baseline 2–5 days later, the patients were randomized to CBZ ERC (n=101; 59% with mixed states) or placebo (n=103; 47% with mixed states) for 3 weeks. An aggressive initial titration schedule was implemented, beginning with 200 mg BID and increased by 200 mg/day until good clinical response was achieved or the patient could not tolerate the dosage. Many patients were taking 1,200–1,600 mg/day by the end of week 1. Efficacy was assessed using the Young Mania Rating Scale (YMRS). The Clinical Global Impressions (CGI) scale and the Hamilton Rating Scale for Depression (HAM-D) were also followed.

Type
Research Article
Copyright
Copyright © Cambridge University Press 2005

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

1.Weisler, RH, Keck, PE Jr, Swann, AC, et al.Extended-release carbamazepine capsules as monotherapy for acute mania in bipolar disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2005;66(3):323330.Google Scholar
2. Data on file, Shire Pharmaceutical Development.Google Scholar
3.Weisler, RH, Kalali, AH, Ketter, TA; SPD417 Study Group. A multicenter, randomized, double-blind, placebo-controlled trial of extended-release carbamazepine capsules as monotherapy for bipolar disorder patients with manic or mixed episodes. J Clin Psychiatry. 2004;65(4):478484.Google Scholar
4.Weisler, RH, Kalali, AH, Ketter, TA. Carbamazepine extended release treatment of manic and mixed symptoms. Poster presented at: 157th Annual Meeting of the American Psychiatric Association; May 1-6, 2004; New York, NY.Google Scholar
5.Keck, PE Jr, Marcus, R, Tourkodimitris, S, et al.A placebo-controlled, double-blind study of the efficacy and safety of aripiprazole in patients with acute bipolar mania. Am J Psychiatry. 2003;160(9):16511658.Google Scholar
6.Keck, PE Jr, Versiani, M, Potkin, S, et al.Ziprasidone in the treatment of acute bipolar mania: a three-week, placebo-controlled, double-blind, randomized trial. Am J Psychiatry. 2003;160(4):741748.Google Scholar
7.Jones, MW, Huizar, K. Quetiapine monotherapy for acute mania associated with bipoler disorder (STAMP 1 and STAMP 2). Poster presented at: The 156th Annual Meeting of the American Psychiatric Association; May 17-22, 2003; San Francisco, CA. Abstract NR432.Google Scholar
8.Tohen, M, Sanger, TM, McElroy, SL, et al.Olanzapine versus placebo in the treatment of acute mania. Olanzapine HGEH Study Group. Am J Psychiatry. 1999;156(5):702709.CrossRefGoogle ScholarPubMed
9.Tohen, M, Jacobs, TG, Grundy, SL, et al.Efficacy of olanzapine in acute bipolar mania: a double-blind, placebo-controlled study. The Olanzapine HGGW Study Group. Arch Gen Psychiatry. 2000;57(9):841849.Google Scholar
10.Hirschfeld, RMA, Keck, PE, Karcher, K, Kramer, ML, Grossman, F. Rapid antimanic effect of risperidone monotherapy: a three-week, multicenter, randomized, double-blind, placebo-controlled trial. Poster presented at: The 156th Annual Meeting of the American Psychiatric Association; May 17-22, 2003; San Francisco, CA. Abstract NR182.Google Scholar
11.Ketter, TA, Kalali, AH, Weisler, RH; SPD417 Study Group. A 6-month, multi-center, open-label evaluation of beaded, extended-release carbamazepine capsule monotherapy in bipolar disorder patients with manic or mixed episodes. J Clin Psychiatry. 2004;65(5):668673.CrossRefGoogle ScholarPubMed
12.Weisler, RH, Keck, PE Jr, Ketter, TA, Swann, AC, Kalali, AH, Cutler, AJ. Efficacy of switching to extended-release carbamazepine in bipolar disorder. Poster presented at: 158th Annual Meeting of the AMerican Psychiatic Asociation; May 21-26, 2005; Atlanta, GA.Google Scholar
13.Ginsberg, LD, Data on file, Red Oak Psychiatry Associates.Google Scholar