A new study has found that while Risperdal, an antipsychotic drug, works well when it comes to treating childhood bi-polar disorder, the drug’s metabolic side effects need to be taken seriously.
Risperdal is a newer atypical antipsychotic drug. It is manufactured by Jannsen Pharmaceuticals, a division of Johnson & Johnson. Risperdal has been known to cause irregular heartbeats, muscle weakness and spasms, high fever, constipation, weight gain and headaches.
Risperdal was originally approved by the Food & Drug Administration (FDA) in 1993 to treat schizophrenia in adults. Later, its approved uses were expanded to include bipolar disorder I in adults, as well as irritability associated with autistic disorders in children from 5 to 16 years of age. Then in August 2007, Risperdal was approved for treatment of schizophrenia in adolescents aged from 13 to 17, as well as the short term treatment of manic or mixed episodes of bipolar I disorder in children aged between 10 and 17. It is not approved as a treatment for Attention Deficit Disorder (ADHD) though it is often prescribed off-label to treat children with the condition.
The study Entitled TEAM (Treatment of Early Age Mania), compared the efficacy of Risperdal with that of Depakote and lithium in children diagnosed with DSM-IV bipolar I disorder (manic or mixed phase). Between 2003 and 2008, 290 children, ages 6 to15 years at five U.S. sites were treated over 8-week periods with either Risperdal, lithium or Depakote. The patients were started on low doses of the drugs, with doses increased on a weekly basis if the child had minimal-to-no response, and no dose-limiting adverse effects.
Of the three drugs, Risperdal was found to be significantly superior for acute treatment of pediatric mania. After eight weeks, 68.5 percent of the children taking Risperdal showed improvement in manic symptoms, compared to 35.6 percent of those taking lithium and 24 percent of those taking Depakote.
The study also found that children responded well at relatively low doses of Risperdal, meaning clinicians can be conservative with the medication. The study authors also noted that lithium had significantly higher discontinuation rates than Risperdal, because Risperal was better tolerated by patients.
However, among the Risperdal group, the researchers saw significantly higher rates of weight gain, BMI increase, and presence of hyperprolactinemia. Children on Risperdal gained an average of more than 7 lbs compared to around 3 lbs for those taking lithium and 3.7 lbs for those taking Depakote. Those taking Risperdal were also more likely to experience other metabollic side effects, such as an increase in cholesterol levels, compared to those on the other medications.
The study was published online January 2 in the Archives of General Psychiatry, and was conducted by Barbara Geller, MD, Department of Psychiatry, Washington University, St Louis, Missouri, and colleagues.