Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a 24-week double-blind, randomized, parallel, placebo-controlled trial.

We assessed the utility of raloxifene (60 mg/day) as an adjuvant treatment for cognitive symptoms in postmenopausal women with schizophrenia in a 24-week, double-blind, randomized, placebo-controlled study. Patients were recruited from the inpatient and outpatient services of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy eight postmenopausal women with schizophrenia were randomized to either adjunctive raloxifene or placebo. Sixty-eight began the clinical trial (37 women on raloxifene adjunct) and 31 on placebo adjunct. The outcome measures were: memory, attention and executive function. Assessment was conducted at baseline and at week 24. Between groups homogeneity was tested with the Student's t test for continuous variables and/or the Mann-Whitney U test for ordinal variables and the χ2 test or Fisher's exact test for categorical variables. The differences between the two groups in neuropsychological test scores were compared using the Student's t test. The sample was homogenous with respect to age, formal education, illness duration and previous pharmacological treatment. The addition of raloxifene to antipsychotic treatment as usual showed no differences in cognitive function. The daily use of 60 mg raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia has no appreciable effect.ClinicalTrials.gov Identifier: NCT01573637.

Design and Validation of an Instrument To Measure a Minor's Maturity When Faced with Health Decisions.

Decision-making capacity in children and adolescents in healthcare requires thorough assessment: the minor's maturity, understanding of the decision, risk of the situation and contextual factors needs to be explored. The intention was to design and validate a test-the Maturtest-to assess the maturity of minors in decision-making processes in healthcare. A reasoning test on moral conflicts for adolescents was designed to infer the degree of maturity of minors applied to decision-making regarding their own health. The test was completed by a sample of 441 adolescents aged from twelve to sixteen, with a corresponding analysis of their psychometric skills to measure feasibility, viability, reliability, validity, and sensitivity to change. Psychometric test results showed viability, reliability, validity, and sensitivity to change. High correlation (correlation index = 0.74) between the test score and the reference method were notable. A high stability was obtained with an intraclass correlation coefficient (r = 0.77). The average response time of the test was twenty-three minutes. This test measures the moral maturity of adolescents. It is presented as an objective, useful, valid, reliable tool, easy to fill out, edit and apply in a healthcare context. It helps to assess the maturity of minors faced with a decision.

Skin Autofluorescence Measurement in Subclinical Atheromatous Disease: Results from the ILERVAS Project.

AIM: Advanced glycation end-products (AGEs) have been involved in the atherogenic process in the high-risk population. The goal of this study was to demonstrate that AGEs are related to subclinical atheromatous disease in subjects with low to moderate vascular risk. METHODS: A cross-sectional study in which 2,568 non-diabetic subjects of both sexes without cardiovascular disease were included. Subcutaneous content of AGEs was assessed by skin autofluorescence (SAF) and subclinical atheromatous disease was measured by assessing the atheromatous plaque burden in carotid and femoral regions using ultrasonography. In addition, serum pentosidine, carboxymethyl-lysine (CML) and AGE receptors (RAGE) were assessed in a nested case-control study with 41 subjects without plaque and 41 individuals subjects with generalized disease. RESULTS: Patients with atheromatous plaque had a higher SAF than those with no plaque (1.9 [1.7 to 2.3] vs. 1.8 [1.6 to 2.1] arbitrary units (AU), p＜0.001). The SAF correlated with the total number of affected regions (r= 0.171, p＜0.001), increasing progressively from 1.8 [1.6 to 2.1] AU in those without atheromatous disease to 2.3 [1.9 to 2.7] AU in patients with ≥ 8 plaques (p＜0.001). A correlation was also observed between SAF and the total plaque area (r=0.113, p＜0.001). The area under the Receiver Operating Characteristic curve was 0.65 (0.61 to 0.68) for identifying male subjects with atheromatous disease. The multivariable logistic regression model showed a significant and independent association between SAF and the presence of atheromatous disease. However, no significant differences in serum pentosidine, CML, and RAGE were observed. CONCLUSIONS: Increased subcutaneous content of AGEs is associated with augmented atheromatous plaque burden. Our results suggest that SAF may provide clinically relevant information to the current strategies for the evaluation of cardiovascular risk, especially among the male population.

Pharmacogenetic study of the effects of raloxifene on negative symptoms of postmenopausal women with schizophrenia: A double-blind, randomized, placebo-controlled trial.

Several double-blind clinical trials have reported improvement in positive, negative and cognitive symptoms of schizophrenia with raloxifene, a selective receptor estrogen modulator. However, there are some inconsistencies in replicating findings between studies of different countries. The failure to replicate these findings may result from genetic factors that could explain some of the variability in the treatment response. However, pharmacogenetic studies exploring this topic in women with schizophrenia are lacking. We aimed to conduct an exploratory pharmacogenetic analysis of a double-blind, randomized, parallel, placebo-controlled study of 24 weeks' duration of raloxifene aiming to improve negative symptoms in postmenopausal women with schizophrenia. Four single nucleotide polymorphisms (SNPs) were studied: rs9340799, rs2234693 and rs1801132 in the Estrogen Receptor 1 (ESR1) gene, and rs1042597 in the UDP-glucuronosyltransferase 1A8 (UGT1A8) gene. Sixty-five postmenopausal women with schizophrenia (DSM-IV) were randomized to either 60mg/day adjunctive raloxifene (36 women) or adjunctive placebo (29 women). Psychopathological symptoms were assessed at baseline and at weeks 4, 12, and 24 with the Positive and Negative Syndrome Scale (PANSS). Of the four studied SNPs, the rs1042597 variant in the UGT1A8 gene was associated with a different treatment response in negative symptoms with raloxifene treatment, whereas the rs2234693 variant in the ESR1 gene was associated with a distinct response in general psychopathology. In conclusion, our study suggests that genetic variants in UGT1A8 and ESR1 genes modulate the treatment response to adding raloxifene to antipsychotic treatment in postmenopausal women with schizophrenia.

Raloxifene as an Adjunctive Treatment for Postmenopausal Women With Schizophrenia: A 24-Week Double-Blind, Randomized, Parallel, Placebo-Controlled Trial.

UNLABELLED: The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator, appears to act similarly to estrogens on dopamine and serotonin brain systems. One previous trial by our team found that raloxifene was useful to improve negative, positive, and general psychopathological symptoms, without having the negative side effects of estrogens. In this study, we assess the utility of raloxifene in treating negative and other psychotic symptoms in postmenopausal women with schizophrenia exhibiting prominent negative symptoms. This was a 24-week, randomized, parallel, double-blind, placebo-controlled study. Patients were recruited from the inpatient and outpatient departments of Parc Sanitari Sant Joan de Déu, Hospital Universitari Institut Pere Mata, and Corporació Sanitària Parc Taulí. Seventy postmenopausal women with schizophrenia (DSM-IV) were randomized to either adjunctive raloxifene (38 women) or adjunctive placebo (32 women). Psychopathological symptoms were assessed at baseline and at weeks 4, 12, and 24 with the Positive and Negative Syndrome Scale (PANSS) and the Scale for the Assessment of Negative Symptoms (SANS). The addition of raloxifene (60 mg/d) to regular antipsychotic treatment significantly reduced negative (P = .027), general (P = .003), and total symptomatology (P = .005) measured with the PANSS during the 24-week trial, as compared to women receiving placebo. Also Alogia SANSS subscale improved more in the raloxifene (P = .048) than the placebo group. In conclusion, raloxifene improved negative and general psychopathological symptoms, compared with antipsychotic medication alone, in postmenopausal women with schizophrenia. These data replicate our previous results with a larger sample and a longer follow-up. TRIAL REGISTRATION: NCT01573637.

The effect of raloxifene on symptoms and cognitive functioning in a postmenopausal schizophrenia patient: a case report.

We report on a 61-year-old postmenopausal female with schizophrenia included in a raloxifene vs. placebo clinical trial and monitored during a 12-month period including a 3-month withdrawal period (6-9 months) without treatment. The patient was treated with raloxifene 60 mg/day adjuvant to antipsychotic medication for 6 months, medication was then withdrawn for 3 months and was reintroduced due to a worsening of symptoms. We assessed the patient with PANSS and other neuropsychological tests. The patient improved in psychopathology and cognitive level in some aspects related to executive functions. During 3 months without the drug, the patient's condition deteriorated. When the drug was reintroduced, improvements were again observed. Raloxifene may be useful as an adjuvant treatment for psychopathological symptoms and some cognitive aspects in women with chronic schizophrenia.

Effects of raloxifene on cognition in postmenopausal women with schizophrenia: a double-blind, randomized, placebo-controlled trial.

Studies of estrogen therapy in postmenopausal women provide evidence of an effect of sex hormones on cognitive function. Estrogen has demonstrated some utility in the prevention of normal, age-related decline in cognitive functions, especially in memory. The potential therapeutic utility of estrogens in schizophrenia is increasingly being recognized. Raloxifene, a selective estrogen receptor modulator (SERM), appears to act similarly to conjugated estrogens on dopamine and serotonin brain systems, and may be a better option since it lacks the possible negative effects of estrogen on breast and uterine tissue. We assessed the utility of raloxifene as an adjuvant treatment for cognitive symptoms in postmenopausal women with schizophrenia in a 12-week, double-blind, randomized, placebo-controlled study. Patients were recruited from both the inpatient and outpatient departments. Thirty-three postmenopausal women with schizophrenia (DSM-IV) were randomized to receive either adjuvant raloxifene (16 women) or adjuvant placebo (17 women) for three months. The main outcome measures were: Memory, attention and executive functions. Assessment was conducted at baseline and week 12. The total sample is homogenous with respect to: age, years of schooling, illness duration, baseline symptomatology and pharmacological treatment. The addition of raloxifene (60 mg) to regular antipsychotic treatment showed: we found significant differences in some aspects of memory and executive function in patients treated with raloxifene. This improvement does not correlate with clinical improvement. The use of raloxifene as an adjuvant treatment in postmenopausal women with schizophrenia seems to be useful in improving cognitive symptoms.

Los niños y adolescentes, ¿pueden tomar decisiones sanitarias? ¿cómo podemos valorarlo? / Can children and adolescents make health-related decisions? How can this be assessed?

El ejercicio de la medicina ha cambiado profundamente durante las últimas décadas, paralelamente a su progreso y a los cambios sociales. Uno de los cambios más importantes es el paso de un modelo basado en la beneficencia a un model basado en la autonomía, donde los pacientes participan en las decisiones sanitarias. En pediatría, el rol de agente activo recae sobre los padres. Pero los niños menoers de edat ¿pueden tomar decisiones sanitarias? Tomar decisiones implica ser competente. La competencia es un fenómeno de todo o nada, o ¿puede haber grados? ¿Cuando podemos afirmar que un niño o adolescente es competente para tomar decisiones sanitarias? El nivell de competencia exigido, ¿es el mismo para cualquier decisión? ¿Es posible valorar objetivamente la competencia en los menores? ¿Puede ser útil implicar a los niños en las decisiones? Este artículo revisa estas cuestiones, y incide especialmente en posibles instrumentos prácticos para medir la competencia en el menor(AU)

Medical practice has changed significantly over the last decades, along the lines of medical progress and social changes. One of the most important changes is the transition from a model of medical relationship based on beneficence to a model based on autonomy, in which patients actively participate in health decisions. In pediatrics, parents have often been the active agents of decisions related to their children. However, can children and adolescents make health decisions? Making a decision implies being competent; however, is competency an "all or nothing" matter, or can it have degrees? When is it possible to say that a child or an adolescent is competent to make a health-related decision? Is the level of competency expected to be the same for any kind of decision? Is it possible to objectively measure the competence of minors? Would it be useful to involve children on decision-making processes? This article looks into all these questions and pays special attention to the possible practical instruments to measure minors' competency(AU)

Valoración de la competencia del menor en relación con la toma de decisiones sanitarias: escala de la competencia de Lleida / Assessmet of the minor’s competency to take sanitary decisions: competency scale in Lleida

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