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Biomedical subjects

Georg Kemmler

Publications and source records attributed to Georg Kemmler.

At least 37 records · Page 2Linked to original sources
PubMed2005

Dropout rates in placebo-controlled and active-control clinical trials of antipsychotic drugs: a meta-analysis.

CONTEXT: Dropout rates in randomized clinical trials of antipsychotic drugs have consistently been reported to be high, and the use of a placebo-controlled design is hypothesized to be one of the reasons for this. OBJECTIVE: To investigate this hypothesis in a meta-analysis of available data from pertinent clinical trials. DATA SOURCES: Comprehensive search of PubMed- and MEDLINE-listed journals. STUDY SELECTION: Double-blind randomized controlled clinical trials of the second-generation antipsychotics risperidone, olanzapine, quetiapine, amisulpride, ziprasidone, and aripiprazole meeting the following criteria: unselected patient population with a diagnosis of schizophrenia or schizoaffective disorder, change in psychopathologic symptoms as the primary end point, and trial duration of 12 weeks or less. DATA EXTRACTION: Sample size, mean age, baseline disease severity, dropout rate, trial design, trial duration, and publication year. DATA SYNTHESIS: Thirty-one trials meeting the inclusion criteria were found, comprising 10 058 subjects. Weighted mean dropout rates in the active treatment arms were significantly higher in placebo-controlled trials (PCTs) than in active-control trials: 48.1% (PCTs) vs 28.3% (active-control trials) for second-generation antipsychotics (odds ratio, 2.34; 95% confidence interval, 1.58-3.47) and 55.4% (PCTs) vs 37.2% (active-control trials) for classical antipsychotics (odds ratio, 2.10; 95% confidence interval, 1.29-3.40). Within PCTs, attrition rates were significantly higher in the placebo arms than with second-generation antipsychotics (60.2% vs 48.1%; odds ratio, 1.63; 95% confidence interval, 1.37-1.94). Within the subset of trials in which both second-generation and classical antipsychotics were used, dropout rates were significantly higher with classical antipsychotics. CONCLUSIONS: Use of a placebo-controlled design had a major effect on the dropout rates observed. Because high dropout rates affect the generalizability of such studies, it is suggested that, in addition to the PCTs, studies with alternative designs need to be considered when evaluating an antipsychotic's clinical profile.

Antipsychotic Agents↗
PubMed2005

The effect of nabilone on neuropsychological functions related to driving ability: an extended case series.

The primary goal of this prospective extended case series was to obtain the first data about the potential influence of nabilone intake on driving ability related neuropsychological functions. Six patients were investigated within a placebo controlled, double-blind crossover study of this synthetic cannabinoid (2 mg/day) in patients with multiple sclerosis and spasticity associated pain. Five neuropsychological functions (reaction time, working memory, divided attention, psychomotor speed and mental flexibility) were assessed. No indication was found of a deterioration of any of the five investigated neuropsychological functions during the 4-week treatment period with nabilone.

Adult↗
PubMed2005

Alcohol and/or benzodiazepine use: different accidents--different impacts?

1611 patients were included in this investigation. 16.7% of the patients were involved in traffic accidents, 38.2% were injured by a sudden fall, 3.5% were involved in an act of violence, 22.8% were injured by a sports related accident and 18.9% were hurt within a work-related accident. 19.5% of the patients tested positive for alcohol, 5.2% tested positive for benzodiazepines and 1.4% tested positive for both substances. Blood samples were positive for alcohol in 27% males and 7.7% females and for benzodiazepines in 6.3% males and in 3.5% females. The mean blood alcohol concentration (BAC) as well as the mean benzodiazepine plasma level were higher in patients injured in violent accidents compared to the other injury groups. This study provides epidemiologic information about the relationship between specific kinds of accidents and alcohol and/or benzodiazepine use in a large probability sample of emergency room patients. We found a high number of patients using alcohol, and a lower but still relavant number of benzodiazepine users in this large and unselected traumatology ER sample. This study adds evidence to the existing literature about the co-occurance of alcohol and/or benzodiazepine consumption and accident-related injuries.

Accidents↗
PubMed2005

Patient outcomes in schizophrenia I: correlates with sociodemographic variables, psychopathology, and side effects.

OBJECTIVE: The present cross-sectional study examined the relationships of psychopathology, side effects, and sociodemographic factors with treatment outcomes in terms of patients' quality of life (QOL), functioning, and needs for care. METHOD: Sixty outpatients with chronic schizophrenia who had been treated with either clozapine or olanzapine for at least 6 months were investigated. RESULTS: Most psychopathological symptoms as well as psychic side effects, weight gain, and female sex were associated with lower QOL, while cognitive symptoms correlated with better QOL. Female sex, cognitive symptoms, and parkinsonism negatively influenced occupational functioning, and negative symptoms determined a lesser likelihood of living independently. Age, education, depression/anxiety, negative symptoms, and psychic side effects were predictors of patients' needs for care. CONCLUSION: Our results highlight the complex nature of patient outcomes in schizophrenia. They reemphasize the need of targeting effectiveness, i.e. both symptomatic improvement as well as drug safety, in such patients.

Adult↗
PubMed2005

Patient outcomes in schizophrenia II: the impact of cognition.

BACKGROUND: Cognitive dysfunction is increasingly considered to be the strongest clinical predictor of poor long-term outcome in schizophrenia. Associations have been found between the severity of cognitive deficits and social dysfunction, impairments in independent living, occupational limitations, and disturbances in quality of life (QOL). METHODS: In this cross-sectional study, the relationships of cognitive deficits and treatment outcomes in terms of QOL, needs, and psychosocial functioning were examined in 60 outpatients with schizophrenia who had a duration of illness over 2 years and had been treated with either clozapine or olanzapine for at least 6 months. RESULTS: The present study suggests that cognitive functioning might be a predictor of work functioning/independent living outcome in stabilized patients with schizophrenia: deficits of visual memory and working memory were negatively associated with occupational functioning, and older patients lived independently and/or in a stable partnership more often. The patients' assessments of QOL and needs for care did not show any significant associations with cognitive functioning. DISCUSSION: These findings suggest that cognitive functioning is a key determinant of work functioning/independent living for stable outpatients with schizophrenia.

Adult↗
PubMed2005

Measurement of tryptophan, kynurenine and neopterin in women with and without postpartum blues.

BACKGROUND: Activation of the tryptophan-degrading enzyme indoleamine (2,3)-dioxygenase was demonstrated to be critically involved in tolerance induction to prevent fetal rejection. Our study was designed to examine alterations of tryptophan and its catabolic product kynurenine in the postpartum period and to compare them to neopterin as an immunological marker. METHODS: 95 healthy women delivering without complications provided blood during labour, and 2 and 4 days after birth. The blood samples were analysed for concentrations of tryptophan, kynurenine and neopterin. Women were asked to perform the Edinburgh Postnatal Depression Scale (EPDS) on days 2 and 4. RESULTS: In women without blues symptoms (n=86) tryptophan concentrations increased within 2 days after birth, whereas they did not change in women with postpartum blues (n=9; 9.5%). The group difference reached statistical significance (p<0.05). The change of the kynurenine to tryptophan ratio (kyn/trp), which estimates the degree of tryptophan degradation, was also different between the two groups at days 0 and 2 (p<0.05). Neopterin concentrations decreased between days 2 and 4 (p<0.05), but there were no differences between the two groups. LIMITATIONS: Our study population had a low prevalence of postpartum blues symptoms. CONCLUSION: Low postpartal mood is associated with continuously low serum tryptophan after delivery due to an increased degradation to kynurenine, but is independent of the postpartal course of neopterin.

Adult↗
PubMed2005

QTc variability in schizophrenia patients treated with antipsychotics and healthy controls.

QTc prolongation is associated with the administration of some antipsychotics but the QTc interval is also known to vary physiologically. There is little published evidence about changes in QTc variability during treatment with antipsychotics. In this prospective investigation, we analyzed ECGs in 61 patients suffering from a schizophrenic disorder who were treated with different antipsychotics and 31 sex- and age-matched healthy controls. We found no differences in QTc intervals nor in QTc variability between patients and controls. Our results raise the question of the clinical relevance of a single ECG for diagnostics of cardiac complications in schizophrenia patients and suggest the need to conduct ECG monitoring in patients at high risk for cardiac complications during antipsychotic treatment.

Adult↗
PubMed2005

Effects of age and sex on olanzapine plasma concentrations.

Age and sex may influence both efficacy and side effects of second-generation antipsychotics. Women and elderly patients tend to have a higher prevalence for several side effects. Higher plasma levels in these groups of patients may be one reason. We studied the hypothesis that steady-state olanzapine plasma concentrations depend on age and sex. Sixty-seven inpatients on stable olanzapine dose were referred to routine therapeutic drug monitoring of olanzapine. Plasma levels were determined by high-performance liquid chromatography with electrochemical detection. Obtained data were then analyzed by analysis of covariance. Olanzapine plasma levels showed a marked sex difference with significantly higher mean concentrations in female patients (adjusted mean concentrations, 18.5 ng/mL for men and 31.7 ng/mL for women; P = 0.003). On average, the weight-corrected concentration/dose ratios shown by women were 33.5% higher than those shown by men, irrespective of age. Regarding the effect of age, weight-corrected concentration/dose ratios increased by an average of 9.4% per decade of life. All results were adjusted for smoking. Comedication did not significantly influence these results. In conclusion, age and sex are important variables to consider when prescribing olanzapine for women and in the elderly.

Adolescent↗
PubMed2005

Quality of life in adult hematopoietic cell transplant patients at least 5 yr after treatment: a comparison with healthy controls.

BACKGROUND AND OBJECTIVE: As long-term survivors of hematopoietic cell transplantation (HCT) become more numerous, studies addressing the issue of long-term follow-up are necessary. In this study, we report on the quality of life (QOL) of HCT-patients, who were alive at least at 5 yr after transplantation in comparison to an age- and sex-matched sample of healthy controls assessed in the same time-period and the same geographical region. DESIGN AND METHODS: The European Group of Research and Treatment of Cancer (EORTC)-QOL Questionnaire (EORTC-QLQ C30) was sent by post to 39 HCT-survivors. Thirty-four patients answered the questionnaire. Patients were compared with 68 healthy controls from the same geographical region. Patients and controls completed the EORTC in the same time period. RESULTS: Mann-Whitney U-tests identified significantly lower QOL on the dimensions of physical and social functioning and on the financial impact symptom scale. CONCLUSIONS: Patients who had survived their HCT for more than 5 yr did generally well in terms of global QOL. This is consistent with Kiss et al. (J Clin Oncol 2002;20:2334-2343), who found that chronic myeloid leukemia patients who were alive at least 10 yr after HCT report lower physical functioning in comparison to healthy controls. Problems in the areas of social functioning and financial difficulty can possibly be addressed by intensive rehabilitation processes integrating patients, family members and significant others. Interdisciplinary (medical, psychological and social) treatment of patients should not come to an end after the acute phase of the illness but should continue during check-ups following transplantation.

Adult↗
PubMed2005

Osteoporosis in patients with schizophrenia.

OBJECTIVE: Osteoporosis is regularly mentioned as a possible consequence of treatment with prolactin-increasing antipsychotic medications, but little is known about the prevalence and the degree of loss of bone mineral density in patients suffering from schizophrenia. The authors' goals were to investigate the association between schizophrenia and a decrease in bone mineral density and to get more insight into potential underlying pathophysiological mechanisms. METHOD: In a cross-sectional study, the authors used dual x-ray absorptiometry to determine bone mineral density of 75 inpatients and outpatients suffering from schizophrenia. All patients had been treated with antipsychotics for at least 1 year, and only patients between the ages of 19 and 50 were studied to exclude patients with age-related idiopathic osteoporosis. RESULTS: In men but not women with schizophrenia, bone mineral density was significantly lower than normal in the lumbar region. A comparison of loss of bone mineral density in male and female patients showed significant differences between the sexes. Bone mineral density showed a negative correlation with negative symptoms and Positive and Negative Syndrome Scale total score and a positive correlation with 25-hydroxy-vitamin D3 levels and body mass index in male patients. In female patients, a positive correlation between body mass index and bone mineral density was found. Exposure to prolactin-increasing antipsychotics was not related to bone mineral density. CONCLUSIONS: The male patients with schizophrenia in this study suffered from low bone density. This finding as well as other reports lend support to directing more attention to bone metabolism in patients with schizophrenia, although there is no universally accepted screening policy to identify individuals at high risk for osteoporosis.

Absorptiometry, Photon↗
PubMed2005

Cross-cultural evaluation of health status using item response theory: FACT-B comparisons between Austrian and U.S. patients with breast cancer.

To make meaningful cross-cultural comparisons of health-related quality of life (HRQOL) or to pool international research data, it is essential to create culturally unbiased measures that detect clinically important differences between patients. We evaluated the measurement properties of the Functional Assessment of Cancer Therapy-Breast (FACT-B) in 111 Austrian and 144 U.S. patients with breast cancer using item response theory (IRT) methods. A small number of items were identified as displaying statistically significant differential item functioning (DIF), suggesting possible measurement bias. The majority of the items functioned similarly between the two cultural groups. U.S. patients reported lower (worse) physical function and well-being compared with Austrian patients, higher (better) social/family well-being and similar emotional well-being, before and after adjustment for DIF. IRT and related measurement models provide useful methods for assessing cross-cultural equivalence and determining which items can be pooled across languages before analyzing HRQOL data. Determination of clinically significant cross-cultural differences will require additional investigation.

Austria↗
PubMed2005

Influence of age and gender on risperidone plasma concentrations.

There is limited information on gender- and age-specific effects on plasma concentrations of risperidone and its active metabolite, 9-hydroxyrisperidone. The present study investigated dose- and weight-adjusted plasma concentrations of risperidone and its metabolite in three age groups (45 years, 45-60 years, over 60 years). Gender-specific differences were examined in the whole sample and for the premenopausal subgroup. One hundred and twenty-nine patients (18-93 years) were included in the study, 52 (40%) male and 77 (60%) female. Concentrations of risperidone and 9-hydroxyrisperidone were measured at steady-state by high-performance liquid chromatography with electrochemical detection (HPLC-ED). When total plasma concentrations (risperidone plus 9-hydroxyrisperidone) were adjusted for daily maintenance dose (ng/mL/mg C/D ratio), significant differences between all age groups were found. We found a mean increase of the C/D ratio by 34.8% per decade in patients older than 42 years. No significant sex-related differences in the average plasma concentrations were observed for the whole sample and for the premenopausal subgroup. This study shows clear evidence of higher risperidone total plasma concentrations for patients over 40 years of age. This linear increase (over 30% per decade) may then lead to an increased incidence of adverse effects in elderly patients.

Adolescent↗
PubMed2005

Perceived functioning, well-being and psychiatric symptoms in patients with stable schizophrenia treated with long-acting risperidone for 1 year.

BACKGROUND: The extent to which antipsychotics improve patients' well-being is uncertain. AIMS: To examine psychopathology and patient-rated functioning and well-being in patients treated with risperidone. METHOD: In a 1-year, open-label, international multicentre trial of long-acting risperidone in 615 stable adult patients with schizophrenia, self-rated functioning and well-being were measured every 3 months using the Short Form 36-item questionnaire (SF-36). Psychopathology was quantified using the Positive and Negative Syndrome Scale (PANSS). RESULTS: Significant improvements were found on the SF-36 mental component summary score and vitality and social functioning scales. PANSS and mental component summary scores were moderately correlated. CONCLUSIONS: Patient-reported functioning and well-being appear to differ from investigator-rated psychotic symptoms. Patient-rated well-being should be assessed with symptoms to help measure treatment outcomes.

Administration, Oral↗
PubMed2004

No evidence for an association between serum cholesterol and the course of depression and suicidality.

In a number of previous reports, an association of altered, in most cases lower, serum cholesterol levels with depression, suicidal ideation and current or past suicidal behavior has been suggested. In this investigation, the course of serum cholesterol concentrations was measured in depressed patients during treatment. Ninety-two inpatients with a major depressive episode were included. Serum lipid concentrations were assessed at admission, after 1 week and after 4 weeks of antidepressant treatment. Degrees of depression and suicidality were measured with the Hamilton Depression Rating Scale. Although there was a significant reduction in depression and suicidality scores, neither a significant change in serum cholesterol levels nor a correlation between cholesterol levels and clinical improvement was found. Further, there were no significant differences in lipid levels between patients with and without a history of attempted suicide. In patients who had used a violent method, there was a trend for lower total cholesterol levels compared to those who had poisoned themselves. The results of this study do not support the hypothesis of an association of serum cholesterol with the course of depression and suicidal ideation. Cholesterol levels do not appear to be an appropriate biological marker for suicidality during the first 4 weeks of treatment in patients with a major depressive episode.

Adult↗
PubMed2004

[The role of alcohol and/or benzodiazepines in occupational accidents compared to accidents due to other causes].

All patients who were admitted within one year to the Department of Traumatology of the Innsbruck University Hospital as a result of an accident were included in this epidemiological study: a total of 1611 patients. 18.9% (n = 304) of these patients were injured as a result of a work-related accident and the remaining 81.2% (n = 1307) were involved in accidents due to other causes. Within the group of patients involved in work-related accidents, alcohol consumption was more frequent in males (13.3%) than in females (1.8%) (p = 0.016) and clearly lower than in patients injured by accidents due to other causes. In work--related accidents we found a correlation between the educational standard of patients and the frequency of alcohol consumption. The mean blood alcohol concentration was lower in patients involved in work-related accidents (0.76 +/- 0.58 g/l) compared to other injuries (1.63 g/l +/- 0.74 g/l). No correlations were found concerning benzodiazepine use and demographic variables and all measured benzodiazepine plasma levels were within the therapeutic range.

Accidents, Occupational↗