Schizophrenia patients achieve further improvements in symptom control with Risperdal(R) Consta(TM)

06/23/04

22 June 2004 Paris Adults in the early stage of schizophrenia or schizoaffective disorder whose symptoms were considered stable on their antipsychotic medication, experienced significant clinical improvements as early as one month after treatment was transitioned to RISPERDAL® CONSTA™ (risperidone) long-acting injection. These patients continued to improve during the six-month trial as measured by the Positive and Negative Syndrome Scale (PANSS)*.

The key findings of this open-label, non-randomised, European multicentre trial were presented today at the XXIVth CINP Congress Collegium Internationale Neuro-Pychopharmacologicum in Paris, France1.

"These results are important because they suggest that changing patients' medication to an atypical, long-acting injectable treatment could result in further improvements in symptom control," said Professor Pierre Michel Llorca, Chairman of the Department of Psychiatry, University Hospital, Clermont-Ferrand, France. "Furthermore, a long-acting injectable treatment can benefit those patients early on in the disease, who have difficulties complying with their medication."

In this study, 119 adults diagnosed with schizophrenia for up to five years (mean duration of illness 2.4 years), who had received previous antipsychotic therapy (60 percent atypical antipsychotics, 28 percent conventional depot and 10 percent conventional oral neuroleptics), were transitioned to risperidone long-acting injection for various reasons, including non-compliance (45 percent) or adverse events with previous medication (29 percent).

The results from the study found that positive and negative symptoms of schizophrenia improved and continued to improve during the six months of treatment with risperidone long-acting injection, as measured by the PANSS. At endpoint, more than one-third (35 percent) of these patients had an improvement of more than 20 percent in the PANSS total score.

Patients also showed a significant improvement on the Clinical Global Impression-Severity (CGI-S)** scale that was maintained throughout the six-month trial. The proportion of patients treated with risperidone long-acting injection who were 'not ill' or 'borderline ill' increased from 8 percent at the beginning to 32 percent at the end of the trial.

In addition, the health status of the patients treated with risperidone long-acting injection and their satisfaction improved at the end of the study with the proportion of patients who rated their satisfaction as 'very good' increasing from 5.9 percent to 33.7 percent.

An estimated one percent of the world's population suffers from schizophrenia2, 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 obvious until later life. People who suffer from schizoaffective disorder experience both severe mood swings, such as mania and/or depression, and some of the psychotic symptoms of schizophrenia. Schizophrenia is marked by "positive" symptoms and "negative" symptoms. "Positive" symptoms are psychological disturbances "added" as a result of the disorder, such as hallucinations, delusions, suspiciousness and paranoia. "Negative" symptoms refer to normal functioning the patient has "lost," resulting in lack of initiative, social withdrawal, lack of expression and emotional withdrawal.

RISPERDAL(R) CONSTA(TM) is the first and only new generation, 'atypical' antipsychotic available as a long-acting injection. It combines the increased efficacy and fewer side effects of an atypical antipsychotic with the benefits of a long-acting formulation. RISPERDAL(R) CONSTA(TM) only needs to be given every two weeks, so patients do not have to worry about remembering to take their medication every day.

RISPERDAL(R) CONSTA(TM) is marketed in most parts of the world by Janssen-Cilag, and has been approved to date in more than 60 countries for the treatment of schizophrenia. The drug was developed by Johnson & Johnson Pharmaceutical Research & Development using a novel technology originated by U.S.-based Alkermes, Inc., in which risperidone is embedded in tiny spheres of biodegradable polymer ("microspheres") that gradually degrade at a controlled rate following intramuscular injection.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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