BackgroundTreatment of bipolar disorder (BD) usually requires drug combinations. Combinations of lithium plus valproic acid (Li/VPA) and lithium plus carbamazepine (Li/CBZ) are used in clinical practice but were not previously compared in a head-to-head trial.ObjectiveThe objective of this trial was to compare the efficacy and tolerability of Li/VPA versus Li/CBZ in treating type 1 BD in any phase of illness in young individuals.MethodsLICAVAL was a randomized, unicenter, open-label, parallel-group trial that was conducted from January 2009 to December 2012 in a tertiary hospital in São Paulo, Brazil. Participants were between 18 and 35 years old and were followed up for 2 years. Our primary outcome was the number of participants achieving/maintaining response and remission during the acute and maintenance phases of BD treatment, respectively. Other outcomes assessed were symptom severity and adverse events throughout the study. In the analysis of the primary outcome, we compared groups by using a two-way repeated measures analysis of variance and estimated effect sizes by using Cohen’s d.ResultsOf our 64 participants, 36 were allocated to Li/VPA and 28 to Li/CBZ. Our sample was composed predominantly of females (66.6%) and the average age was 27.8 years. A total of 27 (45.0%) participants had depression, 17 (28.3%) had mania/hypomania, and 16 (26.7%) had a mixed state. We found no between-group differences in CGI-BP (Clinical Global Impression Scale modified for use in bipolar disorder) scores (P = 0.326) or in any other outcome. Side effects differed significantly between groups only in the first week of treatment (P = 0.021), and there were more side effects in the Li/VPA group. Also, the Li/VPA group gained weight (+2.1 kg) whereas the Li/CBZ group presented slight weight loss (−0.2 kg).ConclusionOur study suggests that Li/VPA and Li/CBZ have similar efficacy and tolerability in BD but that Li/CBZ might have metabolic advantages in the long term.Trial registrationClinicalTrials.gov identifier: NCT00976794. Registered on September 9, 2009.
Objective:To determine the prevalence of otitis media with effusion in children younger than 1 year and its association with the season of the year, artificial feeding, environmental and perinatal factors.Methods:Retrospective study of 184 randomly included medical records from a total of 982 healthy infants evaluated for hearing screening tests. Diagnosis of otitis media with effusion was based on otoscopy (amber-gold color, fluid level, handle of malleus position), type B tympanometric curves and absence of otoacoustic emissions. Incomplete medical records or those describing acute otitis media, upper respiratory tract infections on the assessment day or in the last 3 months, neuropathies and craniofacial anomalies were excluded. Data such as gestational age, birth weight, Apgar score, type of feeding and day care attendance were compared between children with and without otitis media with effusion through likelihood tests and multivariate analysis.Results:25.3% of 184 infants had otitis media with bilateral effusion; 9.2% had unilateral. In infants with otitis media, the following were observed: chronological age of 9.6±1.7 months; gestational age >38 weeks in 43.4% and birth weight >2500g in 48.4%. Otitis media with effusion was associated with winter/fall, artificial feeding, Apgar score <7 and day care attendance. The multivariate analysis showed that artificial feeding is the factor most often associated to otitis media with effusion.Conclusions:Otitis media with effusion was found in about one third of children younger than 1 year and was mainly associated with artificial feeding.
BackgroundLittle attention has been given to efficacious treatment and adherence to treatment of compulsive sexual behavior (CSB).AimsRandomized controlled trial investigated short-term psychodynamic group therapy followed by relapse prevention group (STPGP-RPGT) and pharmacological treatment (PT) for CSB men on sexual compulsivity and adherence.Method135 men, 38 (SD = 9) years old on average, were randomly assigned to 1) STPGP-RPGT; 2) PT; 3) Both. Participants completed measures at baseline, 25th, and 34th week. 57 (42.2%) participants dropped out between baseline and 25th week, and 68 (50.4%) between baseline and 34th week. 94 (69.6%) did not adhere (80% pills taken or attended 75% therapy sessions).ResultsA significant interaction effect was found between time and group (F (4, 128) = 2.62, P = 0.038, ES = 0.08), showing who received PT improved less in sexual compulsivity than those who received STPGP-RPGT (t = 2.41; P = 0.038; ES = 0.60) and PT + STPGP-RPGT (t = 3.15; P = 0.007, ES = 0.74). Adherent participants improved more in sexual compulsivity than non-adherent at the 25th week (t = 2.82; P = 0.006, ES = 0.65) and 34th week (t = 2.26; P = 0.027, ES = 0.55), but there was no interaction effect, F (2, 130) = 2.88; P = 0.06; ES = 0.04). The most reported behavior (masturbation) showed greater risk of non-adherence (72.6%).Discussion and conclusionsAdherent participants improved better than non-adherent. Participants who received psychotherapy improved better than those who received PT. Methodological limitations preclude conclusions on efficacy.
Background
The UK Biobank is a large middle-aged cohort recruited in 2006–2010. We used data from its participants to analyze mortality, survival, and causes of death associated with mental disorders.
Methods
Our exposures were mental disorders identified using (1) symptom-based outcomes derived from an online Mental Health Questionnaire (n = 157 329), including lifetime/current depression, lifetime/current generalized anxiety disorder, lifetime/recent psychotic experience, lifetime bipolar disorder, current alcohol use disorder, and current posttraumatic stress disorder and (2) hospital data linkage of diagnoses within the International Classification of Diseases, 10th revision (ICD-10) (n = 502 422), including (A) selected diagnoses or groups of diagnoses corresponding to symptom-based outcomes and (B) all psychiatric diagnoses, grouped by ICD-10 section. For all exposures, we estimated age-adjusted mortality rates and hazard ratios, as well as proportions of deaths by cause.
Results
We found significantly increased mortality risk associated with all mental disorders identified by symptom-based outcomes, except for lifetime generalized anxiety disorder (with hazard ratios in the range of 1.08–3.0). We also found significantly increased mortality risk associated with all conditions identified by hospital data linkage, including selected ICD-10 diagnoses or groups of diagnoses (2.15–7.87) and ICD-10 diagnoses grouped by section (2.02–5.44). Causes of death associated with mental disorders were heterogeneous and mostly natural.
Conclusions
In a middle-aged cohort, we found a higher mortality risk associated with most mental disorders identified by symptom-based outcomes and with all disorders or groups of disorders identified by hospital data linkage of ICD-10 diagnoses. The majority of deaths associated with mental disorders were natural.
Objective:The Montgomery-Åsberg Depression Rating Scale (MADRS) is widely used to assess depression severity. The Structured Interview Guide for the MADRS (SIGMA) was created to standardize MADRS assessment. The objective of this study was to translate and validate the original SIGMA into a Brazilian Portuguese version (SIGMA-VB).Methods:We translated and cross-culturally validated the original SIGMA into the SIGMA-VB, and assessed its psychometric properties using data from 93 adult outpatients enrolled in the Integral Assessment in Unipolar Depression (AIUNI) trial. Participants were assessed by two raters on five visits over 8 weeks. We calculated multiple interrater reliability indexes for the SIGMA-VB and used the Hamilton Depression Hating Scale (HAM-D) for validation purposes.Results:According to the SIGMA-VB, participants had moderate depression at baseline followed by mild depression at 8 weeks. We found over 90% of correlation between scores attributed by different raters using the SIGMA-VB. Correlations between the SIGMA-VB and the HAM-D were above 66%.Conclusion:Our findings confirm that the SIGMA-VB is a valid and reliable instrument to assess depression severity in clinical research and practice. Its interrater reliability was similar to that of a previously published Japanese version of the SIGMA.
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