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Introduction: The current report evaluates the efficacy and safety of methylphenidate transdermal system (MTS) compared with placebo transdermal system (PTS) in adolescents with attention-deficit/hyperactivity disorder (ADHD).
Methods: A total of 217 subjects participated in a 7-week, randomized, double-blind, multicenter, parallel-group, placebo-controlled, dose-optimization study of MTS (10-, 15-, 20- or 30-mg/9 hours). Subjects were randomized into a 2:1 MTS to PTS ratio and titrated to an optimal dose during an initial 5-week period. Subjects maintained their optimal dose through a subsequent 2-week period. The primary outcome measure was the ADHD Rating Scale-IV (ADHD-RS-IV). Safety of MTS was assessed throughout the study by analyzing adverse events, results of physical examinations, laboratory evaluations, vital sign data, electrocardiograms, and dermal evaluations.
Results: Treatment with MTS demonstrated greater reductions from baseline in ADHD-RS-IV total score compared to PTS at endpoint (P <.0001). The majority of the adverse events (98.5%) were mild or moderate in intensity, the most common of which were decreased appetite, headache, irritability, and upper respiratory tract infection. Three subjects in the MTS group discontinued because of an application site reaction.
Conclusions: MTS therapy was generally well-tolerated and resulted in significantly greater improvements in ADHD symptoms in adolescents when compared to PTS.
Objective: This is the first trial examining duloxetine for generalized social anxiety disorder (GSAD) and the effect of increased dose for those without early remission.
Methods: Individuals (n=39) with GSAD received 6 weeks of open-label duloxetine 60 mg/day; those with a Liebowitz Social Anxiety Disorder Scale (LSAS) score >30 at week 6 were randomized in double-blind fashion to an additional 18 weeks of continued duloxetine 60 mg/day or to duloxetine 120 mg/day.
Results: Duloxetine was associated with a significant LSAS reduction at week 6 (91.3 [17.7] to 69.8 [28.5], paired t [df]=5.2 , P<.0001), and randomized participants overall continued to improve at week 24 (74.6 [23.9] to 60.3 [29.7]; paired t [df]=3.3 , P=.0026). Though the increased dose strategy was associated with a moderate effect size (Cohen's d=.57), there was no significant difference at week 24 endpoint in LSAS reduction (20.5 [26.0] versus 7.3 [17.2], t [df]=1.6 , P=.13) nor remission (33% versus 8%) for duloxetine with dose increased to 120 mg/day compared to duloxetine continued at 60 mg/day. Overall, 44% (17/39) discontinued prior to week 24.
Conclusions: Though with limited power, these data provide preliminary support for the efficacy of duloxetine for GSAD, and suggest continued improvement but limited remission overall at 24 weeks for individuals remaining symptomatic at week 6. These observations warrant further controlled study.
Background: Cross-cultural factors attributed to obsessive-compulsive disorder (OCD) that are widely investigated around the world are mostly epidemiological, with no respect to the impact of culture on the structure of OCD behavior itself.
Methods: Nine Israeli and nine British OCD patients with respective non-OCD individuals were compared. To determine whether OCD symptoms are consistent across cultures, similarities in behavior were analyzed, as well as differences due to a country effect. In each country, nine OCD patients and nine non-OCD individuals were videotaped while performing the task that the patients attributed to their behavior.
Results: Except for a significantly higher rate of repetition and higher performance of idiosyncratic acts, patients from both Israel and the United Kingdom showed high levels of similarities in 22 out of 24 parameters. Compared with Israeli subjects, British OCD patients had significantly longer chains of idiosyncratic acts, and a twice-higher prevalence of brief (1–2 second) idiosyncratic acts. Between-country differences were mild, possibly overridden by the conspicuous impact of OCD pathology, resulting in a similar OCD phenotype.
Conclusion: These results qualitatively and quantitatively emphasize the universal appearance of the compulsions in OCD symptoms.
Background: This study compared the 16-item Clinician and Self-Report versions of the Quick Inventory of Depressive Symptomatology (QIDS-C16 and QIDS-SR16) and the 10-item Montgomery-Asberg Depression Rating Scale (MADRS) in adult outpatients. The comparison was based on psychometric features and their performance in identifying those in a major depressive episode as defined by the Mini-International Neuropsychiatric Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition.
Methods: Of 278 consecutive outpatients, 181 were depressed. Classical test theory, factor analysis, and item response theory were used to evaluate the psychometric features and receiver operating characteristic (ROC) analyses.
Results: All three measures were unidimensional. All had acceptable reliability (coefficient α=.87 for MADRS10, .82 for QIDS-C16, and .80 for QIDS-SR16). Test information function was higher for the MADRS (ie, it was most sensitive to individual differences in levels of depression). The MADRS and QIDS-C16 slightly but consistently outperformed the QIDS-SR16 in differentiating between depressed versus non-depressed patients.
Conclusion: All three measures have satisfactory psychometric properties and are valid screening tools for a major depressive episode.