The treatment of bipolar disorder is complex due to the presence of varying configurations of symptoms in patients. The primary treatments for bipolar disorder are pharmacological, and often involve second generation antipsychotics. Based on its high affinity for both serotonin and dopamine receptors, clozapine has been proposed as a treatment for the disorder.

What is the evidence for clozapine?

Moderate to low quality evidence suggests improved symptoms and reduced hospitalisation, suicidal ideation, and aggressive behaviour, and also improved social functioning with clozapine in people with treatment-resistant bipolar disorder. There were no differences in efficacy for mania symptoms between clozapine and olanzapine or quetiapine.

November 2021

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Bipolar disorder is a persistent, episodic, and debilitating condition associated with recurring episodes of mania, hypomania, depression, and mixed manic-depressive states. These symptoms can lead to severe functional impairment, substance abuse, and suicidal behaviour. Treatment guidelines advocate the use of individual medications, with multiple medications indicated when a patient relapses on maintenance treatment. Unsatisfactory response to therapies is common in bipolar disorder, particularly during depressive episodes. Hence, there is a need to study medications that specifically target people with treatment resistance.

What is the evidence for medication for treatment resistance?

Moderate quality evidence finds the dopamine agonist pramipexole added to standard mood stabilisers can improve treatment-resistant bipolar depression. There may also be some improvement with the mood stabilisers modafinil or armodafinil. A single infusion of ketamine can improve depression one day after infusion, but is not sustained by two weeks after infusion.

Moderate to low quality evidence suggests clozapine and triiodothyronine may be effective for treatment-resistant bipolar disorder, including mania symptoms with clozapine, although the side effects of clozapine require careful monitoring.

November 2021

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Antipsychotic medications provide symptom respite and improvement in quality of life for many people with schizophrenia. However, for a subset of people with schizophrenia, antipsychotic medications do not provide adequate relief from symptoms. Treatment-resistant schizophrenia has many definitions that vary depending on the individual study, but a broad definition includes those patients whose symptoms have not responded to antipsychotic medications, or only partially responded.

What is the evidence for treatment resistance?

Moderate to high quality evidence finds a general pattern of superiority of clozapine, olanzapine or risperidone over other antipsychotics for improving symptoms in people with treatment-resistant schizophrenia.

For people with inadequate response to clozapine, moderate to high quality evidence finds augmenting clozapine with other second-generation antipsychotics may improve negative and depressive symptoms, but not necessarily positive symptoms. Adjunctive sulpiride and adjunctive ziprasidone were particularly effective for negative symptoms, and adjunctive aripiprazole and adjunctive ziprasidone were particularly effective for depressive symptoms. Moderate to low quality evidence finds improved total symptoms with clozapine augmentation of antidepressants fluoxetine, paroxetine and duloxetine. Adding mood stabilisers topiramate, sodium valproate or lithium to clozapine may also improve total symptoms, while adding memantine, a glutamatergic agent, may improve negative symptoms. Adding electroconvulsive therapy may also improve treatment response.

High quality evidence finds better clozapine response in younger people and in people diagnosed with paranoid schizophrenia. Moderate to low quality evidence suggests patients with lower Positive And Negative Syndrome Scale negative subscale scores at baseline also have a better response to clozapine. There were no relationships between response to clozapine and gender, smoking, weight, years of education, marital status, age at onset, age at first hospitalisation, number of hospitalisations, duration of illness, length of stay during hospitalisations, baseline total scores on the Brief Psychiatric Rating Scale, the Clinical Global Impression scale, and the Positive And Negative Syndrome Scale, or on the Positive And Negative Syndrome Scale baseline positive subscale scores.

October 2020

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