304 – Efficacy of bifeprunox in patients in the post-acute, maintenance phase of schizophrenia: Findings from a 6-month study

BackgroundThe symptoms and signs of schizophrenia have been firmly linked to high levels of dopamine in specific areas of the brain (limbic system). Antipsychotic drugs block the transmission of dopamine in the brain and reduce the acute symptoms of the disorder. This review examined whether antipsychotic drugs are also effective for relapse prevention. ObjectivesTo review the effects of maintaining antipsychotic drugs for people with schizophrenia compared to withdrawing these agents. Search methodsWe searched the Cochrane Schizophrenia Group's Specialised Register (November 2008), with additional searches of MEDLINE, EMBASE and clinicaltrials.gov (June 2011). Selection criteriaWe included all randomised trials comparing maintenance treatment with antipsychotic drugs and placebo for people with schizophrenia or schizophrenia-like psychoses. Data collection and analysisWe extracted data independently. For dichotomous data we calculated relative risks (RR) and their 95% confidence intervals (CI) on an intention-to-treat basis based on a random-effects model. For continuous data, we calculated mean differences (MD) or standardised mean differences (SMD) again based on a random-effects model. Main resultsThe review currently includes 65 randomised controlled trials (RCTs) and 6493 participants comparing antipsychotic medication with placebo. The trials were published from 1959 to 2011 and their size ranged between 14 and 420 participants. In many studies the methods of randomisation, allocation and blinding were poorly reported. Although this and other potential sources of bias limited 1 Maintenance treatment with antipsychotic drugs for schizophrenia (Review)

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Maintenance treatment with antipsychotic drugs for schizophrenia

Leucht

Tardy

Komossa

et al. 2012

Cochrane Database of Systematic Reviews

192

144

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Maintenance treatment with antipsychotic drugs for schizophrenia

Ceraso

Lin

Schneider‐Thoma

et al. 2020

Cochrane Database of Systematic Reviews

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Bifeprunox versus placebo for schizophrenia

Chattopadhyay

Frey

Green

2016

Cochrane Database of Systematic Reviews

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Our results showed some positive effects and a favourable adverse effect profile for bifeprunox, although there were few data overall and none were of high quality. It would seem that these data alone would not have been enough for the FDA to decide to halt progress of the drug to market. We can only assume that we are missing important data. Both the FDA and the relevant pharmaceutical companies have not made all relevant data accessible. As some of these trials also involved an additional haloperidol, olanzapine, quetiapine, or risperidone arm, these data are not only relevant to evaluation of bifeprunox. In not making all data accessible, it is hard to see how the FDA and the drug companies have fulfilled their full obligations to people with schizophrenia or their clinicians.

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304 – Efficacy of bifeprunox in patients in the post-acute, maintenance phase of schizophrenia: Findings from a 6-month study

Cited by 3 publications

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Maintenance treatment with antipsychotic drugs for schizophrenia

Maintenance treatment with antipsychotic drugs for schizophrenia

Maintenance treatment with antipsychotic drugs for schizophrenia

Bifeprunox versus placebo for schizophrenia

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