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NEW YORK -- Gauging the winds of medical advances is an iffy proposition at best, but for psychiatrists the new year is likely to bring much-anticipated data on the safety and efficacy of antipsychotic and bipolar medications in children and adolescents.
NEW YORK, Jan. 18 -- Gauging the winds of medical advances is an iffy proposition at best, but for psychiatrists the new year is likely to bring much-anticipated data on the safety and efficacy of antipsychotic and bipolar medications in children and adolescents.
With pediatric safety and efficacy data lacking for most drugs used to treat schizophrenia and bipolar disorder, use of these drugs in pediatric patients is more off-label than on-label, noted Christoph U. Correll, of the Albert Einstein College of Medicine in the Bronx. Dr. Correll is also a member of the American Academy of Child and Adolescent Psychiatry (AACAP).
But an ongoing initiative on the part of industry, academia, and the NIH to change the situation should bear fruit in 2007, Dr. Correll said, just as it did in 2006 with the announcement of a new indication for treating irritability in childhood autism for Risperdal (risperidone).
Psychiatrists can expect to see new pediatric data, either as presentations at scientific meetings or in peer-reviewed journals, on Geodon (ziprasidone), Seroquel (quetiapine fumarate), and Abilify (aripiprazole) this year, he said.
And new data on one drug, Zyprexa (olanzapine), will likely be submitted to the FDA this year in anticipation of earning a pediatric indication for either schizophrenia or bipolar disorder, Dr. Correll said.
At the least, new pediatric data on Zyprexa should appear in peer-reviewed journals in 2007, Dr. Correll said.
Dr. Correll is a lecturer or consultant for Eli Lilly, AstraZeneca, Bristol-Myers Squibb, Janssen, Solvay Pharmaceuticals, Otsuka Pharmaceutical Group, and Intra-Cellular Therapies.
New guidance on the monitoring and management of diabetes and metabolic syndrome in children and adults on antipsychotic drugs could also be forthcoming in 2007, Dr. Correll said.
The American Diabetes Association workgroup on diabetes and second-generation antipsychotic agents, of which Dr. Correll is a member, may be publishing revised recommendations in 2007 on the basis on new data and a more extensive review of the literature, he said. The current recommendations were published in 2004.
The coming year should bring more clinical trial data on which combinations of antidepressants are most effective in adults, said Robert Freedman, M.D., editor of the American Journal of Psychiatry, published by the American Psychiatric Association.
An important story from 2006 was publication of results from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, Dr. Freedman said.
The study found that only about a third of depressed patients responded to initial treatment with a selective serotonin re-uptake inhibitor (SSRI), he said. Furthermore, the study failed to identify any clearly superior drug for treatment-resistant depression.
"The study showed us that depression is complicated," Dr. Freedman said. "There is no simple solution."
However, helpful information on which treatment strategies are most effective should come this year in the form of further results from the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) trials, Dr. Freedman predicted.
One aim of the NIH-sponsored study is to explore which combinations of antidepressants and mood-stabilizing drugs work best to treat symptoms of depression. Clinicians have increasingly been using such drug combinations, but so far there have not been enough hard data to guide them, Dr. Freedman said.
Similarly, for treating schizophrenia, clinicians can look forward to more definitive information on which antipsychotics are the most effective. This will emerging from a detailed analysis of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) to be presented by the principal investigator in the spring, Dr. Freedman said.
Initial results of CATIE were published in September of 2005, but the study continued to make headlines throughout 2006 as researchers mined the data and debated results.
CATIE was a prospective randomized trial that compared Trilafon (perphenazine), an older antipsychotic drug, with four second-generation antipsychotics in treating chronic schizophrenia. The second generation antipsychotics were Zyprexa (olanzapine), Geodon (ziprasidone), Seroquel (quetiapine fumarate), and Risperdal (risperidone).
CATIE found that Zyprexa had the lowest rate of discontinuation, but that Trilafon was comparable to the other three and "not that much less effective than olanzapine," said principal investigator Jeffrey Lieberman, M.D., of Columbia University.
Dr. Lieberman will present a further overall analysis of the study in the American Journal of Psychiatry this year, possibly in May, Dr. Freedman said.
Finally, clinicians should be better able to determine which adolescents with symptoms of emotional instability may have early onset bipolar disorder, thanks to a series of studies from NIH intramural researchers scheduled to appear his journal in March, Dr. Freedman said.
"We will have some real scientific information to help make this distinction, which will be important to doctors, patients, and parents," Dr. Freedman said.