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Olanzapine is authorised in the world under the following brand names: Olansek, Symbyax, Zydis, Zyprexa, Zyprexa Intramuscular, Zyprexa Zydis.

Results from a recent study suggest that olanzapine (Zyprexa) given in moderate to high doses may be useful in treating schizophrenia in patients who have shown resistance to trials with other antipsychotic medications.

Published in the September 1999 issue of the Canadian Journal of Psychiatry, the prospective, open-label study by Serdar Dursun et al. reported on 16 patients (11 male, five female; mean age 40±7 years) having a documented history of resistance to treatment. Dursun is associate professor and head of clinical pharmacology and experimental psychiatry in the department of psychiatry’s psychopharmacology research unit at Dalhousie University, Halifax, Nova Scotia, Canada.

Patients in the study were consecutive outpatient referrals who had shown poor response to antipsychotic treatment. All patients met the DSM-IV criteria for schizophrenia (mean duration of illness was 16±7 years) and scored at least 45 on the 18-item version of the Brief Psychiatric Rating Scale (BPRS) at baseline. Researchers defined treatment resistance by the following criteria: no significant symptomatic relief from schizophrenia symptoms, no period of good functioning and at least three previous trials with antipsychotics from at least two different chemical classes for a minimum of six weeks in the previous five years. The study excluded any patients with clinically significant organic disorders, or who had shown evidence of alcohol or substance abuse within the preceding six months.

Before entering the study, patients had been taking either a conventional antipsychotic drug or risperidone (Risperdal). The initial dose of olanzapine was 5 mg daily. Based on severity of symptoms and patient tolerance, the dose was increased to as much as 40 mg daily, well above the manufacturer’s recommended maximum daily dose of 20 mg. Patients were followed for 16 weeks, and outcome measures were assessed against baseline scores at weeks 4, 8 and 16. In addition to the BPRS, response to treatment was also assessed using the Global Assessment Scale (GAS), and abnormal movements were measured using the Abnormal Involuntary Movement Scale (AIMS).

At week 4, all patients showed a decline in BPRS scores measured against baseline, and this improvement continued at weeks 8 and 16. Half of the patients responded to treatment, as defined by a 20% decrease in BPRS scores. The mean change in BPRS score for all patients was 18.2%±15.6%, and in the responder group the average drop in score was 43%±11.4%.

Scores on the GAS increased during the study, reaching a final average of 41.25, showing that significant functional impairment persisted in the patients. Abnormal involuntary movements, as measured by AIMS, increased significantly at week 4. At subsequent follow-ups, these scores did not vary significantly from baseline, although mean scores remained above baseline.

No patients dropped out of the study and no serious adverse events were reported, suggesting olanzapine is well-tolerated at high doses. The worsening of involuntary movements shown at week 4 was thought to have resulted from switching medications or from withdrawal effects from the discontinuation of conventional antipsychotics.

Researchers said their findings are limited by several factors, including nonsystematic evaluation of overall medication tolerability, the absence of a control group and a potential for investigator bias in the unblinded study.

The researchers concluded that the study results add to a growing body of evidence that atypical antipsychotic medications may be useful for patients with schizophrenia showing treatment refractoriness. They said that cost-effectiveness and tolerability of olanzapine in high doses requires proper assessment and recommended that treatment-resistant patients be given an eight-week trial of the drug at regular doses before increasing the dose.

Conservative estimates suggest that as many as 30% of patients treated for schizophrenia are refractory to treatment.