Can Australian psychiatrists prescribe clozapine off-label for treatment-refractory bipolar disorder?

The recent Royal Australian and New Zealand College of Psychiatrists (RANZCP) Guidelines (Malhi et al., 2015) for mood disorders supported clozapine’s use in treatment-refractory bipolar disorder (TRBD). The Guidelines noted that ‘Despite a lack of RCT evidence, clozapine is widely regarded as an option for treating severe refractory bipolar disorder’ (p. 1133). However, the Guidelines presented a major dilemma for psychiatrists as they also stated that the clozapine patient monitoring service (CPMS) would not allow prescription for any condition apart from schizophrenia.

The authors recognise the significance of the Guidelines recommending clozapine, having recently commented that the National Institute for Health and Care Excellence (NICE) Guidance was deficient in not including clozapine as an option for TRBD based on the evidence from 15 clinical trials that included 1044 patients (Bastiampillai et al., 2016). Clozapine might be the best antipsychotic medication for TRBD with unique mood-stabilising and anti-suicidal properties (Bastiampillai et al., 2016). Given the continuum that exists between schizo-affective disorder and schizophrenia, we would also suggest that clozapine be considered for treatment-refractory schizo-affective disorder.