Intervention Review

Topiramate for acute affective episodes in bipolar disorder

  1. Kamini Vasudev2,
  2. Karine Macritchie1,
  3. John Geddes3,
  4. Stuart Watson4,
  5. Allan H Young1,*

Editorial Group: Cochrane Depression, Anxiety and Neurosis Group

Published Online: 25 JAN 2006

Assessed as up-to-date: 24 AUG 2005

DOI: 10.1002/14651858.CD003384.pub2


How to Cite

Vasudev K, Macritchie K, Geddes J, Watson S, Young AH. Topiramate for acute affective episodes in bipolar disorder. Cochrane Database of Systematic Reviews 2006, Issue 1. Art. No.: CD003384. DOI: 10.1002/14651858.CD003384.pub2.

Author Information

  1. 1

    University of British Columbia, Department of Psychiatry, Vancouver, Canada

  2. 2

    Stanley Research Centre, Psychiatry, Newcastle, UK

  3. 3

    University of Oxford, Department of Psychiatry, Oxford, UK

  4. 4

    Royal Victoria Infirmary, Department of Psychiatry, Leazes Wing, Newcastle-upon-Tyne, Tyne and Wear, UK

*Allan H Young, Department of Psychiatry, University of British Columbia, Suite 430 Strangway Building, 5950 University Boulevard, Vancouver, V6T 1Z3, Canada. allan.young@ubc.ca.

Publication History

  1. Publication Status: Edited (no change to conclusions)
  2. Published Online: 25 JAN 2006

SEARCH

 

Abstract

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Background

Bipolar disorder is a common recurrent illness with high levels of chronicity. Treatment resistance persists despite the use of established medications, such as lithium and valproate. New medications are required for the treatment of refractory cases. Retrospective and open-label trials have suggested that the anticonvulsant topiramate may be efficacious in bipolar disorder. There is a need to clarify the evidence available in the form of randomised controlled trials for its use in bipolar disorder.

Objectives

To review the evidence for the efficacy and acceptability of topiramate in the treatment of acute mood episodes in bipolar disorder.

Search methods

The Cochrane Collaboration Depression, Anxiety and Neurosis (CCDAN) group search strategy was used. The following databases were searched:
The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), September 2003;
The Cochrane Controlled Clinical Trials Register (CCCTR), September 2003;
EMBASE (1980 to December 2003);
MEDLINE (1966 to December 2003);
LILACS;
PsycLIT;
Psyndex.

Reference lists of relevant papers and major textbooks of mood disorder. Handsearches (specialist journals and conference proceedings). Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable published or unpublished trials.

Selection criteria

Randomised controlled trials which compared topiramate with placebo or with active agents in the treatment of any acute mood episodes in bipolar disorder. Participants were patients with bipolar disorder and were males and females of all ages.

Data collection and analysis

Data extraction and methodological quality assessment were performed independently by two reviewers. For analysis, relative risk was used for binary efficacy outcomes and the weighted mean difference or standardised mean differerence was used for continuously distributed outcomes.

Main results

One randomised controlled trial met the inclusion criteria for the review, a comparison between topiramate and bupropion sustained release (SR) in the adjunctive treatment of depressed patients with bipolar disorder. However, the trial had several limitations in methodology and in the description of data. Its data regarding efficacy required clarification before it could be analysed according to the protocol of this systematic review. From the limited data available, topiramate had efficacy similar to bupropion SR in the adjunctive treatment of bipolar depression.

Both groups of subjects suffered a high drop-out rate. There was no significant difference between the topiramate and the bupropion treated groups in those dropping out for any reason (relative risk 1.60, 95% confidence interval 0.65 to 3.96). There was no significant difference in those withdrawing from the study due to adverse effects (relative risk 1.50, 95% confidence interval 0.51 to 4.43). Although the data on weight loss were not analysed formally, weight loss was marked in the topiramate treated group.

Several unpublished trials have been identified and data from these trials may be included in future reviews.

Authors' conclusions

There is insufficient evidence on which to base any recommendations regarding the use of topiramate in any phase of bipolar illness, either in monotherapy or as an adjunctive treatment.

 

Plain language summary

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

Topiramate for acute affective episodes in bipolar disorder

This systematic review investigated the efficacy and acceptability of topiramate compared to placebo and other agents in the treatment of acute affective episodes in bipolar disorder. One randomised controlled trial met the inclusion criteria for the review, a comparison between topiramate and bupropion sustained release (SR) in the adjunctive treatment of depressed patients with bipolar disorder. However, the published data, particularly the data on efficacy, required clarification before it could be analysed according to the protocol of this systematic review. Several unpublished trials have been identified and data from these trials may be included in future reviews. Currently, there is insufficient evidence on which to base any recommendations regarding the use of topiramate in any phase of bipolar illness, either in monotherapy or as an adjunctive treatment. There is a need for randomised controlled trials examining the efficacy and acceptability of topiramate in the treatment of all acute affective episodes in bipolar disorder.

 

摘要

  1. Top of page
  2. Abstract
  3. Plain language summary
  4. 摘要

背景

Topiramate使用在雙相情感疾患的急性發作

雙相情感疾患是一個常見,會復發且高度慢性化的疾病。即使使用被認可的藥物,譬如lithium及valproate,仍存在治療效果不佳的情況。對於治療無效的個案需要新的藥物。回顧且開放性的試驗顯示抗癲癇藥物topiramate可能對於雙相情感疾患有效。現在有需要隨機控制試驗為基礎的證據來釐清它在雙相情感疾患使用的情形。S

目標

回顧topiramate在治療雙相情感疾患的急性發作,其療效與耐受性的證據。

搜尋策略

使用The Cochrane Collaboration Depression, Anxiety and Neurosis (CCDAN) group search strategy 。搜尋以 下的資料庫: The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register (CCDANCTR), September 2003;The Cochrane Controlled Clinical Trials Register (CCCTR), September 2003;EMBASE (1980 to December 2003);MEDLINE (1966 to December 2003);LILACS;PsycLIT;Psyndex. 相關文獻及重要教科書的引用文章也含括在內。手動方式搜尋專門的期刊及會議紀錄。為了瞭解所有適合的已發表或未發表的試驗,作者、領域內的專家、及藥廠都被聯絡,

選擇標準

隨機控制試驗,其在比較topiramate與安慰劑或其他活性藥物在雙相情感疾患任何情感發作的治療。受試者為雙相情感疾患患者,任何年齡的男女皆可。

資料收集與分析

有兩位回顧者獨立執行資料的收集及試驗方法學的品質評估。分析上,我們使用相對風險在二分法的療效結果,而加權平均差或標準差則使用在連續分佈的結果。

主要結論

有一個符合本篇回顧收入條件的隨機控制試驗,其比較topiramate與bupropion sustained release (SR) 在雙相情感疾患的憂鬱患者上的輔助治療(adjunctive treatment)然而此試驗有許多方法學及描述上的缺陷。針對此篇系統回顧的規定,這些資料須經過確認後方可被分析。從這有限的資料中顯示topiramate與bupropion SR在輔助治療的效果類似。兩組的都有很高的退出率。兩組在退出率上沒有任何顯著的差別,不論其退出的原因為何(relative risk 1.60, 95% confidence interval 0.65 to 3.96)。因為副作用而退出的部份,兩組也沒有顯著差異relative risk 1.50, 95% confidence interval 0.51 to 4.43)。雖然在體重減少的資料沒有正式分析,但在topiramate組減少的較明顯。許多未發表的試驗已被辨認,在未來的回顧將納入這些資料。

作者結論

使用topiramate在任何雙相情感疾患的發作(phase)上,不論在單處方治療(monotherapy)或輔助治療的方面,目前都沒有足夠證據的建議。

翻譯人

本摘要由彰化基督教醫院李柏賢翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

這篇系統性回顧是探究topiramate與安慰劑或其他藥物在雙相情感疾患任何情感發作的治療效果與耐受性。只有ㄧ個隨機控制試驗符合這篇回顧的收入條件,其比較在雙相情感疾患的憂鬱期患者上使用topiramate與bupropion sustained release (SR)作為輔助療法。然而,現有發表的資料,特別是在療效上,根據本篇回顧的規定,需要進ㄧ步的確認曾能進行系統性分析。許多未發表的的試驗已被辨認,在未來的回顧將納入這些資料。目前,使用topiramate在任何雙相情感疾患的發作(phase)上,不論在單處方治療(monotherapy)或輔助治療的方面,都沒有足夠證據的建議。有需要隨機控制試驗來驗證topiramate在雙相情感疾患的所有急性發作的治療效果及耐受性。