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FDA: Saphris (Asenapine) Approval, Schizophrenia and Bipolar

From the FDA: FDA Approves Saphris to Treat Schizophrenia and Bipolar Disorder The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function. “Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy,” said Thomas Laughren, M.D., director of the Division of Psychiatry Products in the FDA’s Center for Drug Evaluation and Research. “Effective medicines can help people with mental illness live more independent lives.” Read the full FDA press release S-P corporate press release

Neuropsychology Abstract of the Day: Schizophrenia and Cognition

Palmer BW, Dawes SE, & Heaton RK. (2009). What Do We Know About Neuropsychological Aspects Of Schizophrenia? Neuropsychology Review . Jul 30 [e-pub ahead of print]. Application of a neuropsychological perspective to the study of schizophrenia has established a number of important facts about this disorder. Some of the key findings from the existing literature are that, while neurocognitive impairment is present in most, if not all, persons with schizophrenia, there is both substantial interpatient heterogeneity and remarkable within-patient stability of cognitive function over the long-term course of the illness. Such findings have contributed to the firm establishment of neurobiologic models of schizophrenia, and thereby help to reduce the social stigma that was sometimes associated with purely psychogenic models popular during parts of the 20th century. Neuropsychological studies in recent decades have established the primacy of cognitive functions over psychopathologic symptom...

Neuropsychology Abstract of the Day: Schizophrenia Clinical Trials

Hill SK, Sweeney JA, Hamer RM, Keefe RS, Perkins DO, Gu H, McEvoy JP, & Lieberman JA. Efficiency of the CATIE and BACS neuropsychological batteries in assessing cognitive effects of antipsychotic treatments in schizophrenia. Journal of the International Neuropsychological Society. 2008 Mar; 14(2): 209-221. Center for Cognitive Medicine, Department of Psychiatry, University of Illinois at Chicago, Chicago, Illinois. Efficient and reliable assessments of cognitive treatment effects are essential for the comparative evaluation of procognitive effects of pharmacologic therapies. Yet, no studies have addressed the sensitivity and efficiency with which neurocognitive batteries evaluate cognitive abilities before and after treatment. Participants were primarily first episode schizophrenia patients who completed baseline (n = 367) and 12-week (n = 219) assessments with the BACS (Brief Assessment of Cognition in Schizophrenia) and CATIE (Clinical Antipsychotic Trials of Intervention Effe...

Neuropsychology Abstract of the Day: Schizophrenia

Barrera A, McKenna PJ, & Berrios GE. Two new scales of formal thought disorder in schizophrenia. Psychiatry Research. 2007 Nov 6; [Epub ahead of print] Warneford Hospital, Oxford, OX3 7JX, UK. Information provided by patients and respective carers may help to understand formal thought disorder (FTD) in schizophrenia. Two scales, one for patients (FTD-patient) and one for carers (FTD-carer), were constructed to assess pragmatics, cognitive, paralinguistic, and non-verbal aspects of communication. In the first scale the patients themselves assess their verbal communication; in the second scale the carer assesses the speech of the respective patient. Both scales exhibited internal reliability and evidence of good test-retest reliability. Higher total scores on both scales (FTD-patient and FTD-carer) were significantly associated with positive FTD, but not with negative FTD. Principal component analysis of the scales yielded a multidimensional structure. It is suggested that FTD in s...

The Best of the Brain

While travelling on neuropsych business over the past week, I've been totally enjoying the new collaboration between Dana Press and Dr. Floyd Bloom - an edited book of feature articles from Scientific American . The book contains 21 articles of the many that have appeared in the magazine from 1999 onward. My favorite is the last one, "The Quest for a Smart Pill," by Stephen Hall. I may be mistaken, but I believe Hall has also written on this topic for the journal, Science . It deals with memory- and other cognitive-function- enhancing drugs currently under development by a number of biotech companies and some of the ethical issues involved in this domain. Good reads on the neurobiology of psychiatric disorders and computer-brain interfaces also are included. Articles by Antonio Damasio, Eric Kandel, and Fred Gage are representative of some of the neuroscientific leaders found in the book. Science journalist Carl Zimmer is represented, as well. List price of $25.00, The Be...

Risperdal (risperidone) and Pediatric Schizophrenia and Bipolar DIsorder

An FDA press release from yesterday: FDA Approves Risperdal for Two Psychiatric Conditions in Children and Adolescents The U.S. Food and Drug Administration today 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 FDA approval of an atypical antipsychotic drug to treat either disorder in these age groups. Until now, there has been no FDA-approved drug for the treatment of schizophrenia for pediatric use and only lithium is approved for the treatment of bipolar disorder in adolescents ages 12 and up. “The pediatric studies of Risperdal provided an opportunity to assess the effectiveness, proper dose, and safety of using this product in the pediatric population,” said Dianne Murphy, M.D., director of FDA’s Office of Pediatric Therapeutics. “These data have permitted the identification of the effectiv...