Results Of A New Study Show Benefits Of Risperdal(R) Consta(R) (Risperidone Long-Acting Injection) In First Episode Psychosis

Main Category: Schizophrenia
Also Included In: Clinical Trials / Drug Trials
Article Date: 16 Feb 2006 - 14:00 PDT

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Interim data shows that after treatment with Risperdal(R) Consta(R) (risperidone long-acting injection, RLAI) at the onset of their illness, people with first episode psychosis experienced significant improvements in their clinical symptoms and in their social and occupational functioning, compared to baseline.1,2

The findings, from this study, presented for the first time at the 13th Biennial Winter Workshop on Schizophrenia Research, 2006, Davos, Switzerland, showed that RLAI was found to be effective and generally well tolerated in people experiencing a first episode of psychosis.2

"It is vitally important that a person's first experience of antipsychotic treatment is positive, as this can have a lasting impact on the individual's attitude to taking medication long-term," said Professor Robin Emsley, Lead Investigator, University of Stellenbosch, South Africa. "These results suggest that long-acting injectable formulations such as Risperdal(R) Consta(R) should be considered as first line therapy for people experiencing a first episode of psychosis and may improve the long term outcomes for those patients."

Following 1 week of treatment with oro-dispersible risperidone tablets, patients were initiated onto treatment with long-acting risperidone 25mg every 2 weeks. Patients demonstrated significant improvements in mean total scores of the Positive and Negative Syndrome Scale (PANSS), with 74 per cent of patients achieving at least a 50 per cent reduction in their corrected PANSS total score after six months.2

Patients' functioning was observed to increase on average by 67 per cent at six months (as measured by the Social and Occupational Functional Assessment scale, SOFAS),1

and patients' attitudes towards their illness also significantly improved, generally shifting towards a less severe perception of their illness (as measured by the Patient Global Impression scale, PGI-S).

Overall, treatment was generally well tolerated in this study and there was a high patient retention rate (86 per cent).2

In this study, the vast majority (96%) of treatment emergent adverse events during the first six months of the trial were mild-to-moderate, and most (83%) resolved after six months. The most common adverse event was headache.

Extrapyramidal Symptom Rating Scale (ESRS) scores were low at baseline and declined further at six months.2

Results presented are a pre-specified, six-month interim analysis of an ongoing two-year, open label clinical trial in 51 patients with recent onset schizophrenia, schizophreniform disorder or schizoaffective disorder diagnosed within the last 12 months

Positive and negative symptom scale (PANSS) is a validated, multi-item inventory for evaluating the severity of positive and negative symptoms of schizophrenia. At six months, patients achieved a mean reduction in their PANSS total score of -37.2 SD19.1 (p=0.0001).2

Social and Occupational Functional Assessment scale (SOFAS) is a tool to assess social and occupational functioning in a person with schizophrenia.

Patient Global Impression scale (PGI-S) is a tool used by people with schizophrenia to self-assess the severity of their illness.

Janssen-Cilag Ltd (www.janssen-cilag.co.uk), manufacturer of Risperdal(R) Consta(R) (http://www.risperdal-consta.co.uk), Risperdal(R) (risperidone) and Risperdal(R) Quicklet(R) is part of the Johnson & Johnson family of companies, a leading research-based pharmaceutical company, with more than 110,000 employees worldwide and establishments in approximately 50 countries.

Symptoms of schizophrenia include hearing voices, hallucinations and delusions, apathy, social withdrawal and a lack of emotional expression. For further information on schizophrenia, please log on to http://www.oneinonehundred.co.uk, or call the 1 in 100 helpline on 0800 587 1153 to request a free information pack.

References:
1 Medori R, et al. (2006) Functional recovery in patients with first-episode psychosis treated with long-acting risperidone as a first-line treatment: 6-month interim analyses. Poster presented at 13th Biennial Winter Workshop on Schizophrenia Research, 2006, Davos, Switzerland.
2 Emsley R, et al. (2006) First-line treatment with long-acting risperidone in patient with first-episode psychosis: safety and efficacy results from a 6-month interim analysis. Poster presented at 13th Biennial Winter Workshop on Schizophrenia Research, 2006, Davos, Switzerland.

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