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  • 1
    Publication Date: 2016-09-10
    Description: The use of placebos in clinical trials has major policy implications for ethical conduct across all of medicine and is relevant to clinicians, patients, drug development, and regulatory agencies....
    Keywords: Clinical trials (epidemiology), Medicines regulation, Drugs: psychiatry, Psychotic disorders (incl schizophrenia), Research and publication ethics
    Topics: Medicine
    Published by BMJ Publishing Group
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  • 2
    ISSN: 1360-0443
    Source: Blackwell Publishing Journal Backfiles 1879-2005
    Topics: Medicine , Psychology
    Notes: The alcohol withdrawal syndrome is a common phenomenon in psychiatric hospital care. Not only treatment strategies, but also the evaluation of the syndrome, are discussed controversially. The most widely used instrument is the Clinical Institute Withdrawal Assessment-Alcohol (CIWA-A) and the succeeding CIWA-Ar. We modified the CIWA-A and translated it into German. Validity and reliability of the modified and translated scale were analysed by several psychological tests as well as different somatic measures in 31 patients. The German version appears to be a valid and reliable instrument for the assessment of alcohol withdrawal syndrome useful for clinical routine as well as treatment trials.
    Type of Medium: Electronic Resource
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  • 3
    ISSN: 1433-0407
    Keywords: Schlüsselwörter Eisenbahn ; Suizid ; Fernsehen ; Werther-Effekt ; Key words Train ; Suicide ; Television ; Werther effect
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Description / Table of Contents: Summary Suicide on railways (either by being run over by or jumping in front of a train) is one of the ’hardest' suicide methods. In Austria, 617 suicides or attempted suicides on railways were registered between 1990 and 1994. This amounts to 5.73 % of all suicides committed in this period with women showing a higher percentage than men. In both men and women there was a predominance of younger age groups; the mean age was higher in women than in men (48.0 vs 40.4 years). There was a significant increase in suicides or attempted suicides on railways after a television report on the stress suffered by train drivers concerning possible suicides. Persuading the mass media to treat the subject of ’suicide' with reserve and with greater caution, even when not presenting a distinct suicide model, may be of importance in general suicide prevention.
    Notes: Zusammenfassung Selbstmord durch Überrollenlassen oder Werfen vor einen Zug stellt eine der härtesten Suizidmethoden dar. In den Jahren von 1990–1994 wurden in Österreich 617 versuchte oder vollzogene Eisenbahnsuizide registriert. Der Anteil an den Gesamtsuiziden betrug 5,73 %, wobei der Anteil bei den Frauen höher lag. Insgesamt waren v. a. jüngere Altersgruppen betroffen; das Durchschnittsalter der weiblichen Opfer war mit 48,0 Jahren höher als das der Männer (40,4 Jahre). Ein signifikanter Anstieg fand sich nach einer Fernsehsendung, in der über die psychische Belastung von Zugführern durch einen möglichen Eisenbahnsuizid berichtet wurde. Ein zurückhaltender Umgang der Medien mit dem Thema Suizid und eine größere Vorsicht in der Berichterstattung, auch wenn kein konkretes Suizidimitationsmodell dargestellt wird, scheint von bisher unterschätzter Bedeutung für die Suizidprävention zu sein.
    Type of Medium: Electronic Resource
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  • 4
    ISSN: 1432-0584
    Keywords: Key words BMT ; Quality of life ; FACT-BMT ; EORTC-QLQ C30
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract  Quality of life (QoL) was investigated in 56 BMT recipients. The objective was to compare QoL in terms of physical, emotional, and social functioning between patients within the first year after BMT (n=15) and patients who were alive more than 1 year after BMT (n=41). The Functional Assessment of Cancer Therapy Scale (FACT-BMT) and the EORTC-Quality of Life Questionnaire (EORTC-QLQ C30) were used to evaluate QoL as perceived by the patients. Results show a significantly reduced general QoL in patients within the first year after BMT. Specific differences were identified on the dimensions of physical and emotional well-being and the symptom scales of appetite loss, fatigue, pain, dyspnea, and nausea and vomiting. QoL improves significantly with time after BMT. We suggest that there should be more integration of QoL expectancy into the pre-BMT information process. Patients should be informed about potential deficits in physical and emotional well-being within the first year after BMT. This could enhance insight and compliance in the critical period early after BMT.
    Type of Medium: Electronic Resource
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  • 5
    ISSN: 1432-2072
    Keywords: Clozapine ; Smoking ; Sex ; Age ; Plasma levels
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Drug monitoring in psychiatry is of increasing interest due to compliance problems, side effects of psychoactive drugs and thesearch for adequate dosage. In the present study, plasma levels of clozapine, as determined by high performance liquid chromatography, were investigated in 148 patients receiving a daily dose between 12.5 and 700 mg clozapine. Regression analysis revealed a linear relationship between dose and plasma concentrations. Plasma concentrations at a given dose (level divided by dose and body weight) in male patients reached only 69.3% of the concentrations in female patients (Mann-Whitney U Test P〈0.001). When the patients were divided into smokers and non-smokers, the corresponding plasma levels were also found to be linearly dose dependent in each of the two groups. However, the average plasma concentration at a given dose was only 81.8% in smokers, compared to non-smokers. This difference was statistically significant (variance analysis P=0.022). Dividing female patients into smokers and non-smokers, the smokers reached nearly the same plasma levels as the non-smokers. Male smoking patients reached average plasma concentrations which were only 67.9% of those of non-smokers. This difference was statisticallysignificant (Mann-Whitney U Test P-0.0083). The plasma levels of the different age groups at a given dose per kg body weight were compared using the Mann-Whitney U Test. Significant differences were found between group 1 (18–26) and group 4 (45–54), (P〈0.01) and group 2 (27–35) and group 4 (P〈0.01) showing higher plasma levels in the older age group. The present results indicate a considerable variation of clozapine plasma levels at a given dose depending on a number of factors. These factors should be taken into consideration for efficient therapy with the lowest possible dose.
    Type of Medium: Electronic Resource
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  • 6
    ISSN: 1432-2072
    Keywords: Schizophrenia ; negative symptoms ; clinical trials ; psychiatric status rating scales ; neuroleptics
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract There is little agreement about the methodology of clinical trials of antipsychotic drugs in patients with negative symptoms. A literature review revealed wide variation in experimental design, rating scales and study duration. This reflects differing views as to the definition and response to treatment of negative symptoms. Some degree of standardization would improve comparability of studies and aid the development of new compounds. Patients included in such studies should have displayed negative symptoms for at least 6 months. Depressive symptoms, positive schizophrenic symptoms and extrapyramidal signs may all influence or be confused with negative symptoms and may respond to treatment; they should be at a low level at baseline and should be measured during the study period. Studies should last at least 8 weeks. Several scales are available for measuring negative symptoms and are reviewed; a global impression score should be used additionally.
    Type of Medium: Electronic Resource
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  • 7
    ISSN: 1432-2072
    Keywords: Schizophrenia ; D1-dopamine antagonists ; SCH 39166 ; Antipsychotic ; Negative symptoms
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract In the present open study the effects of the D1-dopamine antagonist SCH 39166 on positive and negative symptoms of schizophrenia (DSM-IIIR) were investigated. SCH 39166 was given orally according to a fixed dosage schedule (day 1: 25 mg b.i.d; day 4: 50 mg b.i.d.; day 7: 100 mg b.i.d; day 18: 200 mg b.i.d.; day 21: 225 mg b.i.d.). Seven patients completed 2 weeks, and five patients completed the study. The reason for premature withdrawal was lack of efficacy or refusal to take SCH 39166. In none of the patients a reduction of the BPRS or CGI score was found. As measured with the PANSS, a significant reduction was observed in the score of the negative subscale, whereas the positive symptoms scale and general psychopathology score remained unaffected. Akathisia, rigidity and hypokinesia were reported occasionally, although only mild in severity. The results of the present study do not support the hypothesis that D1-dopamine antagonists are clinically effective antipsychotics in schizophrenia, considering the fact that SCH 39166 had no effect on positive symptoms. The present study provides circumstantial evidence for an effect of SCH 39166 on negative symptoms.
    Type of Medium: Electronic Resource
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  • 8
    ISSN: 1432-2072
    Keywords: Drug induced akathisia ; Hillside Akathisia Scale ; Interrater reliability ; Validity ; Neuroleptic-induced akathisia
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Akathisia usually consists of two components, subjective restlessness and typical movements such as shuffling of the legs, pacing, shifting weight from one leg to the other, and rocking movements of the trunk. The ability to measure akathisia reliably is essential for the assessment of treatments for akathisia and for the evaluation of drug-induced side effects in general. To date, investigators have generally used self-constructed assessment scales without reporting data about reliability or validity. The Hillside Akathisia Scale (HAS) has two subjective and three objective items for which anchored rating points are provided. Reliability was 0.89 for the HAS total score. Reliability for rating subjective symptoms ranged from 0.86 to 0.92, and the objective scores ranged from 0.51 to 0.89. The correlation between HAS and a global assessment of akathisia (modified CGI) was 0.87. These values compare favorably with the original report on the scale indicating that the Hillside Akathisia Scale can validly quantify akathisia with a satisfactory degree of interrater reliability.
    Type of Medium: Electronic Resource
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  • 9
    ISSN: 1432-2072
    Keywords: Clozapine ; Haloperidol ; Eosinophilia ; Neutropenia ; Agranulocytosis
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The atypical antipsychotic clozapine carries a high risk of inducing agranulocytosis. We attempted to investigate whether eosinophilia during clozapine treatment has predictive value for subsequent neutropenia/agranulocytosis. One hundred and seventy-seven patients were studied in a prospective naturalistic design using haloperidol as the reference compound. Clozapine was found to differ from haloperidol in respect to their influence on neutrophil granulocytes. In the clozapine group patients with eosinophilia showed a decrease in neutrophil count (less than 2000/mm3 neutrophil granulocytes) significantly more often than patients without eosinophilia.
    Type of Medium: Electronic Resource
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  • 10
    Electronic Resource
    Electronic Resource
    Springer
    Psychopharmacology 118 (1995), S. 52-56 
    ISSN: 1432-2072
    Keywords: Antipsychotics ; Neuroleptics ; Clozapine Drug monitoring ; Side-effects ; Parkinsonism Tremor ; Bradykinesia ; Tardive dyskinesia Akathisia ; Haloperidol
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract Neuroleptic-induced extrapyramidal side effects (EPS) were evaluated in 92 patients treated with clozapine for the first time and 59 patients treated with haloperidol followed in a drug monitoring program. Side effects were measured by the Columbia University Rating Scale, the Simpson Dyskinesia Scale and the Hillside Akathisia Scale. The cumulative incidence rate for tremor was found to be 24.4% in the clozapine group and 39.3% in the haloperidol group. This did not amount to a statistically significant group difference. Bradykinesia was observed in 21.8% of the patients treated with clozapine and in 47.7% of the patients of haloperidol (P=0.011). In the clozapine group the akathisia incidence rate was 5.6%, whereas haloperidol patients showed a higher rate of 31.7% (P=0.005). Our results show higher incidence rates of tremor and bradykinesia during clozapine treatment than previous studies. We conclude that clozapine is not entirely free of EPS, but they are usually less severe and of a different quality than side effects induced by typical antipsychotics.
    Type of Medium: Electronic Resource
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