Depot bromperidol decanoate for schizophrenia.

BACKGROUND

Antipsychotic drugs are the mainstay treatment for schizophrenia. Long-acting depot injections of drugs such as bromperidol decanoate are extensively used as a means of long-term maintenance treatment.

OBJECTIVES

To assess the effects of depot bromperidol versus placebo, oral antipsychotics and other depot antipsychotic preparations for people with schizophrenia in terms of clinical, social and economic outcomes.

SEARCH STRATEGY

Relevant trials were identified by searching Biological Abstracts (1982-1999), Cochrane Library (Issue 2, 1999), Cochrane Schizophrenia Group's Register (May 1999), EMBASE (1980-1999), MEDLINE (1966-1999) and PsycLIT (1974-1999). References of all identified trials were inspected and Janssen-Cilag was contacted in order to identify more trials. An update search was undertaken in October 2003. The Schizophrenia Groups trials register is based on regular searches of BIOSIS Inside; CENTRAL; CINAHL; EMBASE; MEDLINE and PsycINFO; the hand searching of relevant journals and conference proceedings, and searches of several key grey literature sources. A full description is given in the Group's module.

SELECTION CRITERIA

All randomised trials focusing on people with schizophrenia where depot bromperidol, oral antipsychotics or other depot preparations were sought. Primary outcomes were death, clinically significant change in global function, mental state, relapse, hospital admission, adverse effects and acceptability of treatment.

DATA COLLECTION AND ANALYSIS

Data were extracted independently by two reviewers and cross-checked. Fixed effects relative risks (RR) and 95% confidence intervals (CI) were calculated for dichotomous data. Weighted or standardised means were calculated for continuous data. Where possible, the number needed to treat statistic (NNT) was calculated. Analysis was by intention-to-treat.

MAIN RESULTS

Four controlled clinical trials were included (total n=117). We identified a single small study of six months duration comparing bromperidol decanoate with placebo injection. Similar numbers left the study before completion (n=20, 1 RCT, RR 0.4 CI 0.1 to 1.6) and there was no clear differences between bromperidol decanoate and placebo for a list of adverse effects (n=20, 1 RCT, RR akathisia 2.0 CI 0.21 to 18.69, RR increased weight 3.0 CI 0.14 to 65.9, RR tremor 0.33 CI 0.04 to 2.69). When bromperidol decanoate was compared with fluphenazine depot we found no important change on global outcome (n=30, RR no clinical important improvement 1.50 CI 0.29 to 7.73). People allocated to fluphenazine decanoate and haloperidol decanoate had less relapses than those given bromperidol decanoate (n=77, RR 3.92 Cl 1.05 to 14.60, NNH 6 CI 2 to 341). People allocated bromperidol decanoate required additional antipsychotic medication somewhat more frequently than those taking fluphenazine decanoate and haloperidol decanoate but the results did not reach conventional levels of statistical significance (n=77, 2 RCTs, RR 1.72 CI 0.7 to 4.2). The use of benzodiazepine drugs was very similar in both groups (n=77, 2 RCTs, RR 1.08 CI 0.68 to 1.70). People left the bromperidol decanoate group with the same frequency as those allocated other depots (n=97, 3 RCTs, RR 1.92 CI 0.8 to 4.6). Anticholinergic adverse effects were equally common between bromperidol and other depots (n=47, RR 3.13 CI 0.7 to 14.0) and additional anticholinergic medication was needed with equal frequency in both depot groups, although results did tend to favour the bromperidol decanoate group (n=97, 3 RCTs, RR 0.80 CI 0.64 to 1.01). The incidence of movement disorders was similar in both depot groups (n=77, 2 RCTs, RR 0.74 CI 0.47 to 1.17).

REVIEWERS' CONCLUSIONS: Currently, minimal poorly reported trial data suggests that bromperidol decanoate may be better than placebo injection but less valuable than fluphenazine or haloperidol decanoate. If bromperidol decanoate is available it may be a viable choice, especially when there are reasons not to use fluphenazine or haloperidol decanoate. Well-conducted and reported randomised trials are needed to inform practice in Belgium, Germany, Italy and the Netherlands.