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Extended-release carbamazepine capsules as monotherapy in bipolar disorder : pooled results from two randomised, double-blind, placebo-controlled trials.

AbstractOBJECTIVES:
Recently, two large, 3-week, randomised, double-blind, placebo-controlled trials using nearly identical protocols demonstrated that monotherapy with carbamazepine extended-release capsules (CBZ-ERC) was effective for the treatment of acute mania in patients with bipolar I disorder. By pooling data from these two trials, a more highly powered analysis of the efficacy and safety of CBZ-ERC in bipolar I disorder could be conducted.
METHODS:
Efficacy was assessed with the Young Mania Rating Scale (YMRS), the Clinical Global Impression (CGI)-Severity (CGI-S) scale, the CGI-Improvement (CGI-I) scale and the Hamilton Depression Rating Scale (HDRS). A sub-analysis of the data based on manic versus mixed presentation was performed, as well as sub-analyses by age, sex and ethnicity.
RESULTS:
Of the 443 randomised patients in the pooled population, 240 completed the studies. Forty-two percent of CBZ-ERC-treated patients did not complete the studies, compared with 50% of placebo-treated patients (p=0.087). Ten percent of patients given CBZ-ERC withdrew because of lack of efficacy, compared with 22% of patients given placebo (p<0.001). At endpoint, CBZ-ERC compared with placebo was associated with significant improvements in mean YMRS total scores in patients experiencing both manic (p<0.0001) and mixed (p<0.01) episodes, using last-observation-carried-forward analyses. CGI-I and CGI-S scores also showed significant improvements from baseline for both manic and mixed patients at endpoint. In patients with mixed episodes, at endpoint there was a mean improvement in HDRS total score of 4.8 points with CBZ-ERC, compared with 2.3 points with placebo (p<0.05). Ninety percent of patients given CBZ-ERC experienced an adverse event, compared with 64% of those patients given placebo. Discontinuation because of adverse events occurred in 10.8% of patients taking CBZ-ERC, compared with 5.5% of patients taking placebo.
CONCLUSIONS:
These results confirm previous findings that CBZ-ERC is effective in the treatment of bipolar I disorder patients with either acute manic or mixed episodes. These data suggest that further randomised controlled studies are warranted to delineate the effect of CBZ-ERC on depressive symptoms in patients with bipolar disorder.
AuthorsRichard H Weisler, Robert Hirschfeld, Andrew J Cutler, Thomas Gazda, Terence A Ketter, Paul E Keck, Alan Swann, Amir Kalali, SPD417 Study Group
JournalCNS drugs (CNS Drugs) Vol. 20 Issue 3 Pg. 219-31 ( 2006) ISSN: 1172-7047 [Print] New Zealand
PMID16529527 (Publication Type: Comparative Study, Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)
Chemical References
  • Anticonvulsants
  • Capsules
  • Delayed-Action Preparations
  • Carbamazepine
Topics
  • Adolescent
  • Adult
  • Aged
  • Anticonvulsants (therapeutic use)
  • Bipolar Disorder (drug therapy)
  • Body Weight (drug effects)
  • Capsules (therapeutic use)
  • Carbamazepine (therapeutic use)
  • Case-Control Studies
  • Clinical Trials as Topic
  • Delayed-Action Preparations (therapeutic use)
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Female
  • Follow-Up Studies
  • Humans
  • Male
  • Middle Aged
  • Placebo Effect
  • Psychiatric Status Rating Scales (statistics & numerical data)
  • Randomized Controlled Trials as Topic
  • Time Factors
  • Treatment Outcome

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