FDA Approves Risperdal for Schizophrenia and Bipolar Disorder in Kids

According to a press release, The U.S. Food and Drug Administration has approved Risperdal (risperidone) for the treatment of schizophrenia in adolescents, ages 13 to 17, and for the short-term treatment of manic or mixed episodes of bipolar I disorder in children and adolescents ages 10 to 17.

This is the first time FDA approves an atypical antipsychotic drug to treat both psychological disorders (Schizophrenia and Bipolar Disorder) in these age groups. No FDA-approved drug was available for the treatment of schizophrenia in pediatrics. Lithium was authorized for Bipolar Disorder in certain age group.

According to the press release, the efficacy of Risperdal of manic or mixed episodes treatment of children or adolescents with bipolar disorder was demonstrated in a three-week, randomized, double-blind, placebo-controlled, multicenter trial in patients (109 patients) all of whom were experiencing a manic or mixed episode att he time of enrollment. Treated patients generally had fewer symptoms, including a decrease in their elevated mood and hyperactivity, and other symptoms of their illness.

For schizophrenia in kids (255 adolescents) , two short-term (6 to 8 weeks), double-blind, controlled trials demonstrated the efficacy of Risperdal (risperidone). All participants in the schizophrenia trial were experiencing an acute episode at the time of enrollment. Treated kids generally had fewer symptoms, including a decrease in hallucinations, delusional thinking, and other symptoms of schizophrenia, the FDA said.

According to the National Institute of Mental Health, schizophrenia is a psychiatric a mental illness characterized by impairments in the perception or expression of reality, most commonly manifesting as auditory hallucinations, paranoid or bizarre delusions and/or disorganized speech and thinking.

Significant social or occupational dysfunction occurs with schizophrenia. Several studies have shown genetic, environmental, neurobiological, and psychological and social factors as possible causes of schizophrenia.

Bipolar disorder, on the other hand, is defined as a psychiatric condition in which recurrent episodes of significant disturbance in mood occur. These disturbances range from debilitating depression to unbridled mania. Bipolar disorder was previously known as the Manic-depressive Illness. AS with schizophrenia many factors are involved in the onset and development of the disorder including: genetic, environmental, neurobiological, and psychological and social factors.

This is the first time FDA has given clear indications on how to use psychoactive drugs for disorder treatments. In the past, certain drugs (Haldol, for example) carried vague indications that they could be used for treating in kids.

Both conditions, Schizophrenia and Bipolar Disorder, are relatively uncommon in children. However, when they hit they can be really devastating for kids experiencing them and for their families

Sources:

FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents. FDA Press release. URL: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01686.html

National Institute of Mental Health-Schizophrenia
www.nimh.nih.gov/healthinformation/schizophreniamenu.cfm

National Institute of Mental Health-Bipolar Disorder
www.nimh.nih.gov/healthinformation/bipolarmenu.cfm

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