Study designs of evaluations included in the review
Randomised controlled trials (RCTs) were eligible for inclusion in the review. The duration of follow-up ranged from 3 to 8 weeks in the included studies.
Specific interventions included in the review
Studies that compared adjunctive drug therapy with monotherapy, or an alternative adjunctive drug with drugs currently licensed in the UK or USA for the treatment of bipolar disorder, were eligible for inclusion (eligible drugs were listed). The included studies evaluated adjunctive treatment with quetiapine, loperidol, risperidone, olanzapine and ziprasidone. Mood tabilisers included lithium, valproate semisodium and
Participants included in the review
Studies that reported results separately for patients with acute bipolar mania were eligible for inclusion. Studies of mixed populations had to have randomised patients by bipolar type. In all but one of the included studies patients were diagnosed with bipolar disorder using the American Psychiatric Association's DSM-IV or DSM-III criteria. All participants were currently manic or had mixed mania. With the exception of one study, which was in adolescents, the studies were in adults. In some of the included studies patients were taking a mood stabiliser at study entry.
Outcomes assessed in the review
Inclusion criteria were not specified in terms of the outcomes. The review assessed the following outcomes: changes in mania symptom scores on the Young Mania Rating Scale (YMRS); mania
response (at least 50% improvement from baseline to end point on the YMRS); withdrawal for any reason, lack of efficacy or adverse event; extrapyramidal symptoms; and weight change.
How were decisions on the relevance of primary studies made?
Two reviewers independently selected the studies and resolved any disagreements on inclusion through recourse to a third author.