Subject: A retrospective, cross-sectional observational survey study to analyse the role of Olanzapine in patients with acute exacerbation of schizophrenia.

Schizophrenia is a psychiatric brain disorder characterized by multiple symptom domains, including positive symptoms (e.g. hallucinations, delusions), negative symptoms (e.g. emotional apathy, lack of drive), and cognitive deficits (e.g. impaired memory). The early onset of the disease, along with its chronic course, make it a disabling disorder for many patients and their families.¹

Schizophrenia occurs worldwide, and for decades it was generally thought to have a uniform lifetime morbid risk of 1% across time, geography, and sex. In 2017, 3•5 million people had schizophrenia in India and it contributed to 9.8% to DALYs due to mental disorders in India. The prevalence of schizophrenia increased swiftly in young age groups, peaked in the 35–44 years age group.²

Acute episodes of schizophrenia are characterized by active psychosis, with accompanying exacerbation of negative symptoms mood disturbance, and cognitive impairments. The pervasiveness and severity of symptoms is subjectively distressing, damaging to relationships, incompatible with most employment, and often inconsistent with any level of independent functioning-resulting in hospital admission.³

Treatment objectives for the initial management of acute psychotic episodes are multiple. In the short term, these objectives consist of rapid control of symptoms, particularly agitation and psychotic symptoms, and prevention of harm to the patient or others. Prevention of harm includes reducing suicide risk, self-harm, domestic and public accidents, hostility and assaults, and the medical complications of any co-morbidity. The core treatment consists of administration of benzodiazepines to control agitation and of antipsychotics to control psychotic symptoms.⁴

The selection of medication should be based on a person’s past response to medication, the side effects that might be particularly harmful in individual circumstances, and routes of administration. Long term treatment with appropriate doses of antipsychotic medications is associated with a substantial increase in the life expectancy of patients with schizophrenia, compared to those who do not receive antipsychotic medication.².

Olanzapine, derived from thienobenzodiazepine, is well established as an effective, atypical antipsychotic agent.³ Olanzapine shows affinity at D1-D5, serotonergic (5HT2, 3, 6), muscarinic (subtypes 1-5), adrenergic (alpha 1-2) and histaminergic (H1) binding sites. Comprehensive reviews of olanzapine in the treatment of schizophrenia and bipolar I disorder have been published.

The initial efficacy of olanzapine in acute schizophrenia was based on data from 4 pivotal, 6-week, double blind trials in which reductions in BPRS total scores were significantly or numerically greater with olanzapine compared to placebo and haloperidol. Subsequently, the efficacy of olanzapine in the treatment of acute exacerbations has been confirmed in several randomized, double blind studies using the PANSS.⁵

Oleanz (Olanzapine) tablets are marketed by Sun Pharmaceutical Industries Ltd. Although every product is marketed only after regulatory approval, it is important to know how it performs in day-to-day practice of individual medical practitioners. For this purpose, we have planned to conduct a retrospective, cross-sectional, observational survey to assess the real-life performance of Olanzapine in patients with schizophrenia