This is a protocol for a Cochrane Review (Intervention). The objectives are as follows:

1. To determine the efficacy of Tiagabine:
1.1 in alleviating manic symptoms episodes of bipolar disorder.
1.2 in alleviating mixed affective symptoms in acute episodes of bipolar disorder.
1.3 in alleviating depressive symptoms in acute episodes of bipolar disorder.
1.4 on patients' general health and social functioning as measured by global clinical impression.

2. To review the acceptability of treatment with Tiagabine to patients, measured by numbers and reasons for dropping out of trials, adherence to treatment, and by reference to patients' expressed views regarding treatment.

3. To investigate the adverse effects of Tiagabine treatment including the general prevalence of adverse effects. Some of the adverse effects that have been reported are
dizziness, somnolence, fatigue, headache, tremor, irritability, difficulties in concentration, confusion, insomnia, nystagmus, depression, amnesia, speech difficulties, paraesthesias and incoordination (Leppik 1999). We will elicit the incidence of these adverse events in the review and also record other adverse events, if any, as reported by other authors.

4. To determine the overall mortality rates on Tiagabine treatment and also:
Mortality excluding suicide and verdicts of undetermined death.
Mortality due to iatrogenic causes.
Suicide and verdicts of undetermined death.