A state-wide quality improvement system utilising nurse-led clinics for clozapine management.

OBJECTIVES: This paper describes the implementation of a state-wide clozapine management system to improve the quality of care for those with treatment-resistant schizophrenia. This intervention includes standardised forms, computer-based monitoring and alerting and nurse-led clinics for stable consumers. METHODS: Methods used during system development included medical record and clinical information system audit, consensus review of available evidence and qualitative review of existing forms, systems and stakeholder opinion. RESULTS: Nurse-led monitoring safely reduced medical outpatient appointments by 119 per week in metropolitan public clinics. In the 15 months following the implementation of all interventions, mortality associated with physical illness not related to malignancy was reduced from an average of 5 deaths per year to one. CONCLUSIONS: Differing interpretations of clozapine guidelines have contributed to confusion around monitoring. Standardised documentation has helped to increase understanding and improve protocol adherence. A regular training programme has increased basic knowledge of risks and protocols. Computer-based documentation and alerting systems have improved communication between hospital and community-based teams and prompted early intervention reducing the risk of adverse events. These factors have combined to help improve outcomes in clozapine management. Nurse-led clinics are a safe and efficient alternative for monitoring clozapine treatment.

Long acting risperidone in Australian patients with chronic schizophrenia: 24-month data from the e-STAR database.

BACKGROUND: This observational study was designed to collect treatment outcomes data in patients using the electronic Schizophrenia Treatment Adherence Registry (e-STAR). METHODS: Patients with schizophrenia or schizoaffective disorder in Australia who were prescribed risperidone long-acting injection (RLAI) between 2003 and 2007 were assessed 12-months retrospectively, at baseline and 24-months prospectively at 3-monthly intervals. The intent-to-treat population, defined as all patients who received at least one dose of RLAI at baseline, was used for the efficacy and safety analyses. RESULTS: At total of 784 patients (74% with schizophrenia, 69.8% male) with a mean age of 37.1 ± 12.5 years and 10.6 ± 9.5 years since diagnosis were included in this Australian cohort. A significant improvement in mean Clinical Global Impression - severity score was observed at 24-months (4.52 ± 1.04 at baseline, 3.56 ± 1.10 at 24-months). Most of this improvement was seen by 3-months and was also reflected in mean Global Assessment of Functioning score, which improved significantly at 24-months (42.9 ± 14.5 at baseline, 59 ± 15.4 at 24-months). For patients still receiving RLAI at 24-months there was an increase from a mean baseline RLAI dose of 26.4 ± 5 mg to 43.4 ± 15.7 mg. Sixty-six percent of patients discontinued RLAI before the 24-month period--this decreased to 46% once patients lost to follow-up were excluded. CONCLUSION: Over the 24-month period, initiation of RLAI was associated with improved patient functioning and illness severity in patients with schizophrenia or schizoaffective disorder. Improved outcomes were observed early and sustained throughout the study. TRIAL REGISTRATION: Clinical Trials Registration Number, NCT00283517.

Mirtazapine add-on therapy in the treatment of schizophrenia with atypical antipsychotics: a double-blind, randomised, placebo-controlled clinical trial.

OBJECTIVE: Schizophrenia is a multifaceted illness with positive, negative and cognitive symptom domains. Standard treatments often focus on positive symptoms and may not adequately relieve other symptoms. Previous studies have suggested a role for mirtazapine in schizophrenia, particularly in negative symptoms. This study investigates the efficacy of adding mirtazapine to treatment as usual to alleviate the negative symptoms of schizophrenia. METHODS: In a 6 week, double-blind clinical trial, participants with a diagnosis of schizophrenia and currently being treated with atypical antipsychotic medication were randomised to adjunctive treatment with mirtazapine (30 mg/day) or placebo. The primary outcome measure was improvement in the Positive and Negative Syndrome Scale (PANSS). Measures of cognition, collected at baseline and week 6 only, were analysed using an Analysis of Covariance (ANCOVA) model. All other outcome measures were analysed using a linear mixed model. RESULTS: Forty participants were recruited to the study with equal numbers randomised to each treatment arm. There was no significant difference between mirtazapine and placebo treated participants for improvement in PANSS scores or any of the secondary outcome measures at any stage during the 6-week trial. CONCLUSIONS: This trial does not confirm previous research supporting the use of mirtazapine adjunctive to atypical antipsychotic treatment for schizophrenia.

Olanzapine vs risperidone in the management of schizophrenia: a randomized double-blind trial in Australia and New Zealand.

Improved drug therapy for schizophrenia may represent the best strategy for reducing the costs of schizophrenia and the recurrent chronic course of the disease. Olanzapine and risperidone are atypical antipsychotic agents developed to meet this need. We report a multicenter, double-blind, parallel, 30-week study designed to compare the efficacy, safety, and associated resource use for olanzapine and risperidone in Australia and New Zealand. The study sample consisted of 65 patients who met DSM-IV criteria for schizophrenia, schizoaffective disorder, or schizophreniform disorder. Olanzapine-treated patients showed a significantly greater reduction in Positive and Negative Syndrome Scale (PANSS) total, Brief Psychiatric Rating Scale (BPRS) total, and PANSS General Psychopathology scores at endpoint compared to the risperidone-treated patients. Response rates through 30 weeks showed a significantly greater proportion of olanzapine-treated patients had achieved a 20% or greater improvement in their PANSS total score compared to risperidone-treated patients. Olanzapine and risperidone were equivalent in their improvement of PANSS positive and negative scores and Clinical Global Impression-Severity of Illness scale (CGI-S) at endpoint. Using generic and disease-specific measures of quality of life, olanzapine-treated patients showed significant within-group improvement in most measures, and significant differences were observed in favor of olanzapine over risperidone in Quality of Life Scale (QLS) Intrapsychic Foundation and Medical Outcomes Study Short Form 36-item instrument (SF-36) Role Functioning Limitations-Emotional subscale scores. Despite the relatively small sample size, our study suggests that olanzapine has a superior risk:benefit profile compared to risperidone.

Practical guidelines on the use of paliperidone palmitate in schizophrenia.

OBJECTIVE: Paliperidone palmitate is an atypical long-acting injectable (LAI) antipsychotic that has been approved for use in the US, EU, Australia and numerous other countries for acute and maintenance therapy of schizophrenia. LAI antipsychotics are often viewed as a 'last-resort' treatment for difficult-to-treat patients, however this article considers their role more broadly in the management of partial or non-adherence in schizophrenia. METHOD: A search of MedLine, CTR and PsychInfo was conducted to identify relevant publications and clinical trials (search term 'paliperidone palmitate', up to December 2010). The findings were discussed in a number of teleconferences and the manuscript was finalized with a face-to-face meeting of the authors group. MAIN FINDINGS: Relapse prevention in schizophrenia requires a comprehensive approach to treatment, which includes antipsychotic medication and psychosocial measures as well as family and/or carer involvement. Good symptom control and the interconnected issue of treatment adherence are arguably the most crucial factors for success. Carer and patient feedback should be carefully considered. Negotiation about commencing LAI therapy done early in course of disease is easier than many clinicians believe, although it is not often attempted in practice. Paliperidone palmitate is useful in both the acute and maintenance phases of treatment. COMMENTARY: A case-based approach is presented to suggest various opportunities where use of paliperidone palmitate could be considered within the disease course of schizophrenia. CONCLUSIONS: Paliperidone palmitate offers some advantages in terms of tolerability, simplicity of treatment initiation and long duration between injections. The consensus of the authors is that rather than reserving paliperidone palmitate for use in difficult-to-treat or refractory patients, it could be used to promote adherence and prevent relapse earlier in the course of the illness.