title: Tiagabine in the treatment of acute affective episodes in bipolar disorder: efficacy and acceptability.
abstract: 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. Some open-label reports have suggested that the anticonvulsant tiagabine 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 the treatment of acute affective episodes in bipolar disorder
  
  
  OBJECTIVE
  To review the evidence for the efficacy and acceptability of tiagabine in the treatment of acute mood episodes in bipolar disorder.
  
  
  METHODS
  The following databases were searched on 13-10-2005. The Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Registers (CCDANCTR-Studies and CCDANCTR-References),The Cochrane Controlled Clinical Trials Register (CCCTR),EMBASE,MEDLINE,LILACS,PsycLIT andPsyndex. Reference lists of relevant papers and major textbooks of mood disorder were searched. Handsearches were done (specialist journals and conference proceedings). Authors, other experts in the field and pharmaceutical companies were contacted for knowledge of suitable published or unpublished trials.
  
  
  METHODS
  Randomised controlled trials, which compared tiagabine with placebo or with active agents in the treatment of any acute mood episodes in bipolar disorder, were selected. Studies of participants with bipolar disorder were to be included. Subjects could be of either sex and of all ages.
  
  
  METHODS
  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
  
  
  RESULTS
  We did not find any studies which fulfilled the Cochrane criteria of randomised controlled trials. However, one uncontrolled open label study and one case series were found. There were also three case reports/series of acute treatment which were continued into maintenance therapy, and one open non-randomised study with this design. The results of these studies are inconsistent.
  
  
  CONCLUSIONS
  We found no randomised controlled trials of tiagabine in bipolar disorder. In the reported cases, a significant proportion of patients suffered episodes of syncope or seizure. There is a need for randomised controlled trials examining the efficacy and acceptability of tiagabine in the acute treatment of bipolar disorder, after the nature of these episodes has been clarified.
authors.affiliation: Royal Victoria Infirmary, Department of Psychiatry, Divison of Psychiatry, School of Neurology, Neurobiology and Psychiatry, University of Newcastle upon Tyne, Leazes Wing, Royal Victoria Infirmary, Newcastle-upon-Tyne, UK NW1 4LP. a.h.young@ncl.ac.uk
authors.forename: A H
authors.initials: AH
authors.lastname: Young
authors.forename: J R
authors.initials: JR
authors.lastname: Geddes
authors.forename: K
authors.initials: K
authors.lastname: Macritchie
authors.forename: S N K
authors.initials: SN
authors.lastname: Rao
authors.forename: S
authors.initials: S
authors.lastname: Watson
authors.forename: A
authors.initials: A
authors.lastname: Vasudev
mesh_terms: D018692:Antimanic Agents / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy*; D006801:Humans; D009557:Nipecotic Acids / Q000627:therapeutic use*; D000078308:Tiagabine
chemical_list: D018692:Antimanic Agents; D009557:Nipecotic Acids; D000078308:Tiagabine