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    ABSTRACT: Behavioural problems are common in people with intellectual disability (ID) and are often treated with antipsychotics. To establish the frequency and characteristics of people with ID included in randomised controlled trials (RCTs) on antipsychotic treatment for behavioural problems, and to investigate the quality of these RCTs. A literature search in EMBASE, PubMed and Cochrane was performed and reviewed. People with ID participated in 27 of the 100 included RCTs. The RCTs were of good quality but smaller compared with trials in patients with dementia or schizophrenia (average sample sizes = 55, 124 and 374). In 13/27 trials no clear definition of ID was given. Over 25 different outcome measures were used to assess behavioural problems. Studies in which people with ID are included are of a sufficient quality, but of a small size. The heterogeneity in the characteristics of the ID population included as well as in the applied assessment instruments makes performing meta-analyses unfeasible.
    Journal of Intellectual Disability Research 12/2010; 55(7):650-64. · 1.88 Impact Factor
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    ABSTRACT: Recent studies have identified troubling method and practice lapses in neuropsychiatric drug developments. These problems have resulted in errors that are of sufficient magnitude to invalidate clinical trial data and interpretations. We identify two potential sources for these difficulties: investigators selectively choosing scientific practices for demonstrations of efficacy in human-testing phases of drug development and investigators failing to anticipate the needs of practitioners who must optimize treatment for the individual patient. When clinical investigators neglect to use clinical trials as opportunities to test hypotheses of disease mechanisms in humans, the neuropsychiatric knowledge base loses both credibility and scope. When clinical investigators do not anticipate the need to translate discoveries into applications, the practitioner cannot provide optimal care for the patient. We conclude from this evidence that clinical trials, and other aspects of neuropsychiatric drug development, must adopt more practices from basic science and show greater responsiveness to conditions of clinical practice. We feel that these changes are necessary to overcome current threats to the validity and utility of studies of neurological and psychiatric drugs.
    Science translational medicine 12/2010; 2(61):61rv6. · 10.76 Impact Factor
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    ABSTRACT: To describe the course of positive and negative symptoms during inpatient treatment and examine remission and response rates under routine clinical care conditions. Two hundred and eighty inpatients with schizophrenia (DSM-IV criteria) were assessed with the Positive and Negative Syndrome Scale (PANSS) at admission and at biweekly intervals until discharge from hospital. Remission was defined according to the symptom-severity component of the consensus criteria (Remission in Schizophrenia Working Group) as a rating of three or less in the relevant PANSS items at discharge, and response as a reduction of at least 20% in the PANSS total score from admission to discharge. The mean duration of inpatient treatment was 54.8 days. Of the total sample, 78.5% achieved the criteria for response and 44.6% those for remission. Mean PANSS total scores decreased from 72.4 at admission to 52.5 at discharge (p<0.001). A reduction in PANSS total scores was found from visit to visit, up to week 8. The most pronounced decline was observed within the first two weeks of treatment. Response rates were comparable to those found in efficacy studies, and remission rates were slightly higher. This may be explained by differences in the selection and the treatment of patients. Nevertheless, the findings might indicate that a complex naturalistic treatment approach is beneficial in terms of effectiveness.
    Schizophrenia Research 02/2010; 118(1-3):183-8. · 4.59 Impact Factor

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May 30, 2014