News Release

Comparison of antipsychotic treatments in adolescents with schizophrenia

Peer-Reviewed Publication

Elsevier

Philadelphia, PA, February 28, 2008 – There is a wealth of scientific literature available on the treatment of adults diagnosed with schizophrenia. However, there is a paucity of data to guide the treatment of children and adolescents with schizophrenia. “Although the U.S. Food and Drug Administration (FDA) has recently approved the use of aripiprazole and risperidone for adolescents with schizophrenia, few controlled data are available to help guide clinicians regarding the management of children and adolescents with schizophrenia who fail to respond to these standard 'first-line' antipsychotic treatments,” according to Dr. Sanjiv Kumra. Dr. Kumra is one of the authors of a new study to be published in the March 1st issue of Biological Psychiatry, which was undertaken to help fill this gap in knowledge.

The authors recruited 39 children, 10-18 years of age, who had already failed to respond to at least two antipsychotic treatments, to participate in a 12-week, double-blind, randomized study – the most rigorous of clinical trial designs. After initial assessments, the patients received treatment with either clozapine or “high-dose” olanzapine (doses that exceed the package insert recommendations) and were monitored for improvement in their symptoms. The researchers discovered that clozapine was approximately twice as likely to produce a treatment response as olanzapine. Both positive symptoms (psychosis) and negative symptoms (blunted emotional response, reduced motivation) responded better to clozapine. John H. Krystal, M.D., Editor of Biological Psychiatry and affiliated with both Yale University School of Medicine and the VA Connecticut Healthcare System, comments on the findings: “Olanzapine is among the most effective antipsychotic medications, so the distinctive effectiveness of clozapine in this study could be very important.”

Dr. Kumra discusses this patient population: “The majority of these youth had histories of multiple hospitalizations, extreme violence, suicidality and trauma prior to study enrollment. Without appropriate intervention it is likely that many would have ended up in long-term care institutions, psychiatric prison settings, and/or experienced early death from drug use, violence, or suicide.” So, this preliminary data is hopeful, indicating that proper and effective treatment may be available for these adolescents, although there are also concerns.

Both medications produced significant weight gain and associated metabolic abnormalities. Dr. Krystal also adds that “clozapine has important side effects that have discouraged its prescription to children.” Dr. Kumra agrees, stating that “although clozapine is often considered as a treatment of ‘last resort’ because of its associated risk of agranulocytosis [a severe reduction in the number of white blood cells in the body], the striking symptom reduction observed in this clinical trial make apparent that clozapine has truly revolutionized the care of youth with treatment-refractory schizophrenia.”

Dr. Krystal concludes: “The long-term risks of medications, such as clozapine and olanzapine, will need to be weighed against their potential benefits. Thus, additional research will be needed to follow-up on this exciting but very preliminary finding.”

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Notes to Editors:

The article is “Clozapine and ‘High-Dose’ Olanzapine in Refractory Early-Onset Schizophrenia: A 12-Week Randomized and Double-Blind Comparison” by Sanjiv Kumra, Harvey Kranzler, Ginny Gerbino-Rosen, Hana M. Kester, Courtney DeThomas, Vivian Kafantaris, Christoph U. Correll and John M. Kane. Dr. Kumra is affiliated with the Department of Child and Adolescent Psychiatry, University of Minnesota, Minneapolis, Minnesota. Drs. Kranzler and Gerbino-Rosen are with Bronx Children's Psychiatric Center, Bronx, New York. Drs. Kester, DeThomas, Kafantaris, Correll and Kane are from Zucker Hillside Hospital, Glen Oaks, New York. The article appears in Biological Psychiatry, Volume 63, Issue 5 (March 1, 2008), published by Elsevier.

Full text of the article mentioned above is available upon request. Contact Jayne M. Dawkins at (215) 239-3674 or ja.dawkins@elsevier.com to obtain a copy or to schedule an interview.

About Biological Psychiatry

This international rapid-publication journal is the official journal of the Society of Biological Psychiatry. It covers a broad range of topics in psychiatric neuroscience and therapeutics. Both basic and clinical contributions are encouraged from all disciplines and research areas relevant to the pathophysiology and treatment of major neuropsychiatric disorders. Full-length and Brief Reports of novel results, Commentaries, Case Studies of unusual significance, and Correspondence and Comments judged to be of high impact to the field are published, particularly those addressing genetic and environmental risk factors, neural circuitry and neurochemistry, and important new therapeutic approaches. Concise Reviews and Editorials that focus on topics of current research and interest are also published rapidly.

Biological Psychiatry (www.sobp.org/journal) is ranked 4th out of the 95 Psychiatry titles and 16th out of 199 Neurosciences titles on the 2006 ISI Journal Citations Reports® published by Thomson Scientific.

About Elsevier

Elsevier is a world-leading publisher of scientific, technical and medical information products and services. Working in partnership with the global science and health communities, Elsevier's 7,000 employees in over 70 offices worldwide publish more than 2,000 journals and 1,900 new books per year, in addition to offering a suite of innovative electronic products, such as ScienceDirect (http://www.sciencedirect.com/), MD Consult (http://www.mdconsult.com/), Scopus (http://www.info.scopus.com/), bibliographic databases, and online reference works.

Elsevier (http://www.elsevier.com/) is a global business headquartered in Amsterdam, The Netherlands and has offices worldwide. Elsevier is part of Reed Elsevier Group plc (http://www.reedelsevier.com/), a world-leading publisher and information provider. Operating in the science and medical, legal, education and business-to-business sectors, Reed Elsevier provides high-quality and flexible information solutions to users, with increasing emphasis on the Internet as a means of delivery. Reed Elsevier's ticker symbols are REN (Euronext Amsterdam), REL (London Stock Exchange), RUK and ENL (New York Stock Exchange).


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