Objective: To evaluate the efficacy and tolerability of ziprasidone in behavioral and psychological symptoms of dementia. Method: A 7-week open-label trial of ziprasidone. Results: Of the 25 patients who participated, 15 completed the study. The main reason for discontinuation was adverse events. The mean total Neuropsychiatric Inventory (NPI) score fell significantly from 47.1 ± 17.1 (baseline) to 25.8 ± 17.9 (day 49) (p < 0.01). The NPI caregiver burden showed a significant improvement from 22.6 ± 8.3 at baseline to 11.8 ± 7.3. The most frequent adverse events were somnolence, gastrointestinal symptoms and parkinsonism. Conclusions: Ziprasidone was able to significantly improve distressing non-cognitive symptoms of dementia although adverse effects occurred. Additional large-scale, double-blind, well-controlled studies are necessary to evaluate the use of ziprasidone in this indication.
Approximately 80% of all women of reproductive age experience psychological and physical changes associated with the premenstrual phase. Cognitive alterations are among the most common complaints. In this context, studies have assessed cognitive performance across the menstrual cycle in healthy women and also in women with premenstrual syndrome (PMS). The main objective of the present study was to review the literature on cognitive function in different phases of the menstrual cycle in women of reproductive age, both healthy and with PMS, in particular premenstrual dysphoric disorder (PMDD). We searched MEDLINE and LILACS databases. A total of 27 studies were selected. The studies used heterogeneous methodologies. Most studies suggested that healthy women show small fluctuations in cognitive performance across the menstrual cycle, with low performance scores in the luteal phase for visuospatial and motor skills, attention and concentration, verbal memory, visual memory, working memory, and reaction time. Among women with PMS or PMDD, low performance scores for visuospatial and motor skills, attention and concentration, verbal memory, working memory, reaction time and impulsivity were also detected in the luteal phase. Symptoms observed in PMS/PMDD patients showed low intensity, but greater when compared with healthy women. Evidence indicates fluctuations in cognitive performance in the different phases of the menstrual cycle in healthy and PMS women, with worse performance for women with PMS/PMDD in the luteal phase. However, methodological limitations prevent us from drawing solid conclusions. Further studies are needed to investigate the impact of these cognitive fluctuations on patients' daily activities.
Premenstrual dysphoric disorder (PMDD) affects 3-8% of women of reproductive age and is characterized by severe mood symptoms that cause important functional impairment. Serotonergic antidepressants appear to be an effective treatment for this disorder. The purpose of this study was to collect evidence on the efficacy and tolerability of duloxetine, a dual reuptake inhibitor of serotonin and norepinephrine, in the treatment of PMDD. We conducted a pilot, single-blind, non-controlled, fixed-dose trial. After two cycles for diagnosis confirmation, including a single-blind placebo cycle, 20 women with PMDD were treated continuously for three menstrual cycles with 60 mg/d duloxetine. The primary measure of the efficacy of treatment with duloxetine was the significant reduction in premenstrual symptoms demonstrated by the comparison between the mean Daily Record of Severity of Problems (DRSP) scores at baseline to endpoint (p=0.0002). Statistically significant symptom reduction was observed in the first treatment cycle and throughout all the treatment phase. Clinical response, defined as a reduction 50% of baseline premenstrual symptoms, occurred in 65% of subjects (intention-to-treat population). Significant improvements were demonstrated by secondary measures, including reduction in self-rated functional impairment (p=0.01) and improvement in quality of life (p=0.04). The main side-effects associated with duloxetine were dry mouth, nausea, drowsiness, insomnia, decreased appetite, decreased libido, and sweating. Duloxetine was effective and generally well tolerated in the treatment of PMDD. Further large-scale, double-blind, placebo-controlled studies are needed to evaluate duloxetine as an additional treatment strategy for the management of PMDD.
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