New Study Suggests Clinical Benefits Of Risperdal(R) ConstaTM In Patients With Recent Onset Psychosis

Main Category: Schizophrenia
Also Included In: Psychology / Psychiatry
Article Date: 09 Apr 2008 - 1:00 PDT

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Patients with psychosis treated early on in the course of their illness with Risperdal® ConstaTM (risperidone long-acting injection), demonstrated high response and remission rates with low relapse rates according to a preliminary study published in the April edition of the Journal of Clinical Psychopharmacology. A reduction of the Positive and Negative Syndrome Scale (PANSS) total score of at least 50% was experienced by 84% of the 51 patients included in the study, with only four of these patients relapsing by the study endpoint. During the two-year trial period, the study also showed 64% of patients achieved remission.

Non-compliance or partial compliance remain key barriers in the management of schizophrenia and are often significant contributing factors in relapse. Relapse is associated with increased risk of hospitalisation and a dramatically poorer quality of life. Patients experiencing numerous relapses are at high risk of never regaining previous levels of functioning. Prevention of relapse is paramount in order to support patients towards remission and recovery and is of particular importance in the early stages of the disease to prevent irreversible decrease of functioning.

"The trial suggests that an atypical long-acting formulation introduced as first-line treatment may play an important role in the management of schizophrenia," commented lead investigator of the study Professor Robin Emsley from the Department of Psychiatry at the University of Stellenbosch. "Whilst this is a small study, any data suggesting low relapse and high remission rates during this critical stage in a patient's treatment pathway are welcome."

In the study, risperidone long-acting injection was administered every two weeks to patients with an age range of 15 - 43 years with recent onset schizophrenia or schizophreniform disorder. A total of 27 patients were treatment naïve. The study period ran over two years in order to assess the effects of risperidone long-acting injection on symptom reduction and assess whether it can be used as a first-line treatment in early psychosis. Results showed that 84% of patients experienced a clinical response of at least 50% reduction of symptom severity on the PANSS. Of these patients, only four relapsed during the study. 92% of patients experienced a clinical response of at least 20% reduction of symptom severity.

Young and often medication-naïve patients may manifest high sensitivity to antipsychotics, both in terms of responsiveness and to side effects such as extrapyramidal symptoms and weight gain. Therefore, the lowest dose of antipsychotic medication was used and patients were closely monitored throughout the study. Overall, the results suggest the treatment was well tolerated and the majority of patients responded well to treatment. As previously reported in studies of patients with early onset psychosis, weight gain was reported, particularly in the first 12 months. At endpoint, mean BMI gain was 4.8 (SD 3.8 [n=50]) from 20.6 (SD 4.6) at baseline (p<.001).

Although cautious interpretation of this small, preliminary, open-label and non-comparative study is necessary, it suggests that risperidone long-acting injection is well tolerated and effective in recent onset psychosis. The patients showed improvements in terms of symptom reduction and health related quality of life and functional outcome. Study remission rates were high and relapse rates low.

Risperidone long-acting injection has a favourable efficacy and tolerability profile; it is the first long-acting injectable atypical antipsychotic medication indicated for schizophrenic psychoses and other psychotic conditions. Risperidone long-acting injection only needs to be administered every two weeks, eliminating the daily pill burden associated with oral medications.

An estimated one percent of the world's population will have schizophrenia - a brain disorder that impairs a person's ability to think clearly, relate to others and distinguish between reality and imagination. It typically develops in adolescence or the early 20s, although symptoms may not become immediately obvious.

More information can be found at http://www.psychiatry24x7.com

About Risperdal Consta

Risperdal Consta was first approved in the UK in August 2002, and is now approved in more than 70 countries worldwide. In the UK, it is indicated for use in adults with schizophrenic psychoses and other psychotic conditions. Risperdal Consta has not been studied in children and adolescents younger than 18 years of age. In this investigational study - Risperidone long-acting injection in the treatment of subjects with recent onset psychosis: a preliminary study - 10% (n=5) of the population were under 18 years of age.

Risperdal Consta uses Alkermes proprietary Medisorb® technology to deliver and maintain therapeutic medication levels in the body through just one injection every two weeks. Available in 25 mg, 37.5 mg and 50 mg dose units, it is approved for the treatment of schizophrenia.

About Janssen-Cilag

Janssen-Cilag has dedicated over 50 years of research and development to improving the lives of those who live with severe mental illness and continues to invest in this area.

Janssen-Cilag has a long track record in developing treatments for central nervous system disorders, pain management, oncology, fungal infections and gastrointestinal conditions. Products include Concerta® XL (ADHD), Durogesic® DTrans® (pain management), Eprex® (anemia), Topamax® (epilepsy, migraine prevention), Risperdal® (schizophrenia, bipolar disorder), Risperdal® Consta® (schizophrenia) and Velcade® (progressive multiple myeloma).

More information can be found at http://www.janssen-cilag.co.uk

References

1. Emsley R et al. Risperidone long-acting injection in the treatment of subjects with recent onset psychosis: a preliminary study. J Clin Psychopharmacol 2008; 28(2): 210-213

2. Narasimhan et al. Partial compliance with antipscyhotics and its impact on patient outcomes. Intl Jrnl of Psych in Clinical Practice, 2007: 11(2)

3. Birchwood M, Toddd P, Jackson C. Early intervention in psychosis. The critical period hypothesis. Br J Psychiatry Suppl 1998; 172:53-59

4. NICE, Schizophrenia: Core interventions n the treatment and management of schizophrenia in primary and secondary care. December 2002.

5. Sheitman BB, Lee H, Strauss R, et al. The evaluation and treatment of firstepisode psychosis. Schizophrenia Bulletin 1997;23:653-661.

6. Chatterjee A, Chakos M, Koreen A, et al. Prevalence and clinical correlates of extrapyramidal signs and spontaneous dyskinesia in never-medicated schizophrenic patients. Am J Psychiatry 1995;152:1724-1729.

7. Strassnig M, Miewald J, Keshavan M, et al. Weight gain in newly diagnosed first episode psychosis patients and healthy comparisons: one-year analysis. SchizophrRes 2007;93:90-98.

8. Leal et al. Healthcare resource utilization during 1-year treatment with long-acting, injectable risperidone. Pharmacoepidemiology and Drug Safety, 2004, 13 [pg 811-812]

http://www.janssen-cilag.co.uk