Fábio Lopes Rocha

Prevalence of insomnia and associated socio-demographic factors in a Brazilian community: the Bambuı́ study

BACKGROUND Population-based studies of insomnia among adults residing in communities in developing countries are rare. The objectives of this population-based study were to determine the prevalence and factors associated with insomnia among adults (18 years and over) living in a Brazilian town with 15,000 inhabitants (Bambuí MG) and to determine how the use of different definitions of insomnia affect its prevalence. METHODS A total of 87.3% of 1221 randomly selected individuals aged 18+ participated. Prevalences were estimated based on different definitions. To determine the associated characteristics, insomnia was defined as a complaint in the last month, occurring at least three times a week, causing distress. RESULTS (1) Prevalence ranged from 12.0 to 76.3%; (2) prevalence of insomnia, as defined above, was 35.4%; (3) prevalence among women increased with age and was higher than that of men; (4) insomnia was independently associated with less education in both sexes, and among females it was associated with older age (60+ years). CONCLUSIONS The prevalence of insomnia in Bambuí was high, similar to that of urban centers of developed countries; this investigation substantiated the importance of operational criteria in studies of insomnia.

Combination of antidepressants in the treatment of major depressive disorder: a systematic review and meta-analysis.

Abstract The objective was to perform a systematic review and meta-analysis of studies that assessed the effect of the combination of antidepressants from the beginning of the treatment of major depressive disorder. Studies were retrieved from PubMed (1966 to August 2010), Cochrane Library (August 2010), Embase (1980 to August 2010), PsycINFO (1980 to August 2010), Lilacs (1982 to August 2010), clinical trials registry, thesis database (www.capes.gov.br), and secondary references. All randomized controlled trials that compared a combination of antidepressants with a single antidepressant from the beginning of the treatment of major depressive disorder in adults were included. Data analysis was performed using the Review Manager 5.0. Of 3492 studies retrieved, five satisfied the inclusion criteria. In one study, only data about dropouts were included. Antidepressant combination was shown to be better than a single antidepressant considering remission (relative risk [RR], 2.71; 95% confidence interval [CI], 1.69–4.35) and response (RR, 1.55; 95% CI, 1.21–1.97). Mirtazapine plus selective serotonin reuptake inhibitor (SSRI) was superior to an isolated SSRI for remission (RR, 1.88; 95% CI, 1.06–3.33). Tricyclic antidepressant plus SSRI was superior to SSRI for remission and response (RR, 8.58; 95% CI, 1.70–43.32 and RR, 1.78; 95% CI, 1.07–2.93, respectively). There was no difference between combined and monotherapy groups in dropouts owing to adverse effects. The results suggest that antidepressant combination is more efficient than a single antidepressant without a significant decrease in tolerability. However, the small number of clinical trials and methodological problems precludes definitive conclusions.

A Placebo-Controlled Double-Blind Randomized Study of Venlafaxine in the Treatment of Depression in Dementia

Background/Aims: To evaluate the efficacy and safety of venlafaxine in the treatment of major depression in dementia. Methods: Thirty-one outpatients who had dementia and major depression participated in this randomized, double-blind, placebo-controlled, 6-week, flexible dose clinical trial. The screening measures were Cornell Scale for depression in dementia, DSM-IV for depression and dementia and Mini-Mental State Examination. The outcome measures were response rate, Montgomery-Åsberg Depression Rating scale and Clinical Global Impressions. Results: The percentage of patients defined as Montgomery-Åsberg Depression Rating scale responders was approximately the same in the placebo and in the venlafaxine groups. Clinical Global Impressions showed no significant difference between the groups. The reasons for dropouts show borderline significance between the two groups. There was no statistically significant difference in the incidence of adverse events between the venlafaxine and placebo-treated groups. Conclusions: Our data do not support the hypothesis that venlafaxine improves mood in elderly demented patients.

Antidepressants for depression in Parkinson's disease: systematic review and meta-analysis.

Depression is common in Parkinson’s disease (PD) and is associated with several poor outcomes. However the literature regarding treatment with antidepressants in this population is controversial. The aim of this paper was to systematically review all randomized controlled trials that studied the efficacy of antidepressants for depression in PD (dPD). Studies were retrieved from PubMed (1966–July 2012), Cochrane Library (–July 2012, issue 7), Embase (1980–July 2012), PsycINFO (1980–July 2012), Lilacs (1982–July 2012), secondary references, clinical trials registries and a thesis database. Only double-blind, randomized controlled trials in which an antidepressant was given as the main treatment and compared with placebo and/or another antidepressant were included. Out of the 1438 studies retrieved, only six could be included. Taking into account the five placebo-controlled trials, the overall risk ratio (RR) for response was 1.36 (0.98, 1.87), indicating no statistically significant superiority of antidepressants over placebo. However, in the sensitivity analysis, the RR for response was 1.41 (1.01, 1.96) and 1.48 (1.05, 2.10) after exclusion of one study with questionable results, and when only studies with low risk of bias were considered, respectively. No specific antidepressant class was superior to placebo. In general antidepressant medications were well tolerated. The results suggest antidepressants may be efficacious in the treatment of dPD. However, the results were unstable. In fact, the small number of trials and methodological drawbacks preclude definitive conclusions about their efficacy and tolerability in dPD.

Vitamin B 12 Deficiency and Dementia

We set out to investigate the possible beneficial effects on cognitive function of demented patients with cobalamin deficiency after cobalamin replacement. A total of 181 consecutive, demented (DSM-III or DSM-III-R criteria and score below 24 on the Mini-Mental State Examination [MMSE]) outpatients (mean age 77.5 years) were prospectively evaluated and had their vitamin B12 level measured by radioimmunoassay. The frequency of vitamin B12 deficiency (less than 200 pg/mliter) was 25% (46 patients). Treatment outcome was obtained in 19 patients (19 of 46). Despite cobalamin replacement, 16 of 19 patients persisted in showing progressive decline during follow-up visits (3 to 24 months). The nonresponse to vitamin B12 replacement in most cases seems to reflect the presence of associated irreversible dementia or a follow-up of shorter duration in a few patients. All of the patients who showed some improvement (MMSE returned to normal values) had mild dementia with a history of less than 2 years. Thus, screening for B12 deficiency should be considered in patients with recent onset of mild mental status changes.

Prevalence of sleep complaints and associated factors in community-dwelling older people in Brazil: the Bambuı́ Health and Ageing Study (BHAS)

BACKGROUND Population-based studies of insomnia among older people residing in communities in developing countries are rare. The objectives of this population-based study were to determine the prevalence and factors associated with insomnia among older adults (60 years and over) living in a Brazilian town with 15,000 inhabitants (Bambuí MG). METHODS All 1742 residents in this age group were selected for a structured interview and blood tests. From these, 1516 (87.0%) participated in the study. RESULTS The prevalence of insomnia was 38.9%, being higher among women (45.3%) than among men (28.8%). The use of sleeping pills was reported by 380/1513 (25.1%) of the participants; 186 (49.0%) of these complained of insomnia, suggesting that their treatment should be reassessed. Factors independently associated with insomnia were: female sex (OR=1.78, 95% CI=1.41-2.24), dissatisfaction with free time arrangements (OR=1.88, 95% CI=1.28-2.77), self-rated health as reasonable or bad/very bad (OR=2.02, 95% CI=1.50-2.72 and OR=3.12, 95% CI=2.21-4.39, respectively), history of previous medical diagnosis of some chronic conditions (OR=1.38, 95% CI=1.10-1.73), inability to perform routine activities due to a health problem in the previous 2 weeks (OR=1.54, 95% CI=1.10-2.15), and staying in bed in the previous 2 weeks (OR=1.61, 95% CI=1.04-2.48). CONCLUSIONS The prevalence of insomnia was high, indicating that this was a public health problem for older adults living in the study community. Our results emphasize the necessity for further investigations about insomnia among older people living in small communities in Brazil and other developing countries.

An Exploratory Open-Label Trial of Ziprasidone for the Treatment of Behavioral and Psychological Symptoms of Dementia

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.

Antidepressant combination for major depression in incomplete responders—a systematic review

BACKGROUND Antidepressant combination has been suggested as a strategy to increase treatment efficacy. The objective of this study was to perform a systematic review and meta-analysis of studies that assessed the effect of antidepressant combination for major depression in patients with incomplete response to an initial antidepressant. METHODS Studies were retrieved from PubMed (1966-February, 2012), Cochrane Library (-February, 2012), Embase (1980-February, 2012), PsycINFO (1980-February, 2012), Lilacs (1982-February, 2012), clinical trials registry, thesis database (www.capes.gov.br), and secondary references. Included studies had an open label phase in which an initial antidepressant was used for the treatment of major depression and a double blind phase for the incomplete responders that compared monotherapy with the first antidepressant versus the association of a second antidepressant to the first one. RESULTS Out of the 4,884 studies retrieved, only five satisfied the inclusion criteria. The total number of patients included was 483. Only two small trials reported benefits of adding a second antidepressant to the initial antidepressant. Dropouts due to side effects were not reported in three studies. Meta-analysis was not performed due to the small number of studies, the inconsistency in the direction of effect and the possible instability of effect size. Only limited kinds of combination, involving mianserin, mirtazapine and desipramine were studied. Some properties of the first two drugs such as the anxiolytic, sedative, and orexigenic effects, can mimic depression improvement. LIMITATIONS Publication bias cannot be ruled out. Only one study included a monotherapy arm with the antidepressant used for augmentation of the first antidepressant. CONCLUSIONS The practice of using a combination of antidepressants for major depression in incomplete responders is not warranted by the literature.

The broad autism phenotype in parents of individuals with autism: a systematic review of the literature.

The broad autism phenotype (BAP) is a milder manifestation of the defining symptoms of the syndrome in individuals without autism. This study conducted a systematic review of studies about behavioral characteristics of interpersonal relationships, communication and rigidity, as well as about three cognitive models, Theory of Mind, central coherence and executive function, in parents of individuals with autism. The indexed databases were LILACS, IBECS, Web of Science, and MEDLINE, and the studies retrieved were published between 1991 and March 2012. Parents of individuals with autism have more difficulties in interpersonal relationships and in pragmatic language use and have more rigidity traits. The inclusions of the cognitive theories in the group of BAP characteristics were inconclusive.

Duloxetine treatment for women with premenstrual dysphoric disorder: a single-blind trial

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.