Public Release: 

New study highlights impact of bipolar disorder on society

Ketchum UK

Berlin, Germany -- 4 July 2001 - A new report presented here today at the World Congress of Biological Psychiatry shows that bipolar disorder costs the UK more than £2 billion annually. Up to 85 percent of these costs are associated with loss of productivity due to unemployment, nearly 10 percent are due to absenteeism at work, and just over 5 percent is driven by suicide among this population. Individuals with bipolar disorder suffer from excessive, disruptive swings in mood - from manic episodes, marked by impaired concentration, "racing thoughts" and irritability, to periods of deep depression. The manic phase is often accompanied by an unrealistic belief in one's own abilities; reckless behaviour, such as promiscuity and spending sprees; hallucinations or delusions; substance abuse; and aggression. These symptoms often lead to absenteeism from work, loss of employment, and even suicide; between 25 and 50 per cent of bipolar disorder sufferers attempt suicide world-wide, and 10 to 15 per cent succeed each year. The research on what this means in cost to UK society was conducted by Catalyst, a health-economics consultancy. However, while the actual monetary cost may vary from country to country, it is believed that the basic socioeconomic consequences of the disease are universal.

Risperdal™ (risperidone) Found to be Effective for Treatment of Bipolar Mania In the UK and throughout Europe, conventional antipsychotics have been one of the most common types of medications used to treat bipolar disorder. However, these drugs are associated with severe side effects that often cause patients to discontinue therapy. Their symptoms then re-emerge, putting their lives at risk. "A manic episode is one of the distressing, debilitating conditions of the disorder, and can lead to very harmful consequences for patients and those around them," comments Professor Eduard Vieta, Department of Psychiatry at the University of Barcelona. "Risperidone has been shown to be effective in treating bipolar mania, and causes fewer side effects than the older antipsychotics such as haloperidol."

Risperdal is the first "atypical" antipsychotic medication to be approved in a European country as adjunctive (add-on) therapy for the treatment of acute bipolar mania. To date, Risperdal has been approved for this indication in Spain, Portugal, the Czech Republic, the Philippines and Ireland. "Traditional mood-stabilising drugs, such as lithium, often aren't enough to control acute bipolar mania. However, research shows that patients can obtain relief through the adjunctive use of risperidone," says Professor Vieta.

Two clinical trials have demonstrated that treatment with Risperdal in conjunction with a traditional mood stabiliser such as lithium or valproate can improve control of acute bipolar mania, with onset of action seen in just one week.

In two studies involving a total of 156 hospitalised patients, participants taking Risperdal along with a traditional mood stabiliser for three weeks responded to treatment more rapidly than patients taking a mood stabiliser alone. In addition, significantly more patients taking the two drugs together achieved a reduction in symptoms of at least 50 per cent, compared to those who received only the mood stabiliser. One of the studies also showed that patients who received Risperdal plus mood stabilisers were more likely to show significant improvement in symptoms than those who received a mood stabiliser combined with haloperidol, an older, "conventional" antipsychotic that is the current standard of care. In the studies, Risperdal was generally well tolerated. More patients who took placebo dropped out of the studies due to adverse events than those who received Risperdal. In addition, compared to those who took haloperidol, patients who took Risperdal experienced a lower incidence of movement disorders -- a condition often associated with older antipsychotics such as haloperidol.

Related Study Suggests Broader Use for Risperdal Along with the "manic" phase of bipolar disorder, patients experience 'affective symptoms' -- severe anxiety and depression. These are symptoms that are shared with patients who have schizophrenia or schizoaffective disorder. Data from a one-year, randomised, double-blind clinical trial, also presented at the Biological Psychiatry meeting, indicate that Risperdal is significantly more effective than haloperidol in improving depressive symptoms and reducing the risk of relapse in patients with schizophrenia.

Notes to editors:

Risperdal is currently used for the treatment of schizophrenia and other psychoses, when positive symptoms (hallucinations and delusions) and negative symptoms (emotional and social withdrawal) are present. It is licensed in Spain, Ireland, the Czech Republic, the Philippines and Portugal for the treatment of acute bipolar mania.

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Janssen-Cilag, a wholly owned subsidiary of Johnson & Johnson, is a leader in treatment for disorders of the central nervous system -- including research in schizophrenia, Alzheimer's disease, bipolar disorder and depression. The Janssen Research Foundation developed both haloperidol (HaldolTM, approved in 1958) and Risperdal (1994). In addition, Janssen-Cilag markets compounds in the areas of analgesia, gastroenterology and mycology. It is headquartered in Beerse, Belgium, with affiliates in 39 countries. For more information, visit www.janssen-cilag.com.

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