Skin reactions at the application site of rivastigmine patch (4.6 mg/24 h, 9.5 mg/24 h or 13.3 mg/24 h): a qualitative analysis of clinical studies in patients with Alzheimer's disease.

BACKGROUND AND OBJECTIVES: Rivastigmine patch is approved for the treatment of all stages of Alzheimer's disease (AD). Application site reactions may be a concern to clinicians and we used two large clinical trial databases to investigate the incidence of skin reactions in patients receiving rivastigmine patch. METHODS: Data from a 24-week, randomised, double-blind (DB) evaluation of 13.3 vs. 4.6 mg/24 h rivastigmine patch in severe AD (ACTION) and a 72- to 96-week study comprising an initial open-label (IOL) phase followed by a 48-week randomised, DB phase (13.3 vs. 9.5 mg/24 h rivastigmine patch) in declining patients with mild-to-moderate AD (OPTIMA) were analyzed. The incidence, frequency, severity, management and predictors of application site reactions were assessed. RESULTS: Application site reactions were mostly mild or moderate in severity and reported by similar proportions in each treatment group ( ACTION: 13.3 mg/24 h, 24.5% and 4.6 mg/24 h, 24.2%; OPTIMA: IOL 9.5 mg/24 h, 22.9%; DB 13.3 mg/24 h, 11.4% and 9.5 mg/24 h, 12.0%); none were rated serious. In both studies, <9% of patients required treatment for application site reactions. Application site reactions led to discontinuation of 1.7% and 2.5% of the 13.3 mg/24 h and 4.6 mg/24 h groups, respectively, in ACTION, 8.7% in OPTIMA IOL and 1.8% and 3.5% of the 13.3 mg/24 h and 9.5 mg/24 h groups, respectively, in OPTIMA DB. CONCLUSIONS: Application site reactions were experienced by <25% of patients in both studies, with no notable effect of dose. No reactions qualified as serious and skin reactions were uncommon as a reason for study discontinuation.

MACI personality scale profiles of depressed adolescent suicide attempters: a pilot study. Million Adolescent Clinical Inventory.

Employing the Millon Adolescent Clinical Inventory (MACI), we examined differences in the maladaptive personality style profiles of clinically referred, depressed adolescents presenting with (n = 26) and without (n = 23) a history of previous suicide attempts. Relative to the comparison group, adolescent attempters experienced more severe overall levels of personality dysfunction. At the trait level, attempters obtained higher scores on the forceful and borderline tendency scales and lower scores on the submissive and conforming scales of the MACI, reflecting negative mood regulation deficits (e.g., anger control problems) and persistently high levels of aggressive impulsivity. These preliminary findings suggest that MACI personality scales may be useful in discriminating adolescents with and without previous suicidal behavior, especially among depressed outpatient samples.

Parent-victim agreement in adolescent suicide research.

OBJECTIVE: The necessary absence of the victim's report in psychological autopsy studies is likely to introduce a systematic reporting bias. The authors investigated the nature and extent of this bias by examining agreement between accounts of symptomatology given by adolescents who made a serious suicide attempt and their parents. METHOD: Fifty-two attempters younger than age 20 were matched individually on age, sex, and ethnicity to a sample of suicide completers in two previous investigations. A semistructured interview was used to assess symptoms for DSM-III disorders. Diagnoses were assigned using two distinct computer algorithms, based respectively on youth and parent informant reports. Kappa values were estimated for each diagnostic category and related symptoms. RESULTS: Highest rates of parent-youth agreement were found for substance abuse and disruptive disorders. Rates of conduct disorder (nonaggressive) and major depression were reported less frequently by parents relative to their children. At the symptom level, parents less frequently reported Gets drunk and Frequency of drinking. CONCLUSIONS: Psychological autopsy studies of adolescent suicide are likely to underestimate the prevalence of psychiatric disorders in general and major depression and alcohol abuse in particular. These risk factors may be more predictive than previously thought.

Asking adolescents to explain discrepancies in self-reported suicidality.

We present a typology of adolescents' most common explanations for discrepant reporting of suicidal behavior. Forty-eight adolescents provided attempt histories by completing a self-report measure of suicidality. A select number of items were subsequently readministered (average interval = 5 days) using a semistructured interview format. Discrepancies in reporting were found among 50% of the sample. Adolescents were also asked to clarify, using an open-ended format, what might have accounted for a particular discrepancy. Based on these responses, seven mutually exclusive and exhaustive categories were derived. High rates of interrater agreement indicated that these categories were reliable.

Auditory ERPs during rhyme and semantic processing: effects of reading ability in college students.

Event-related potential (ERP), reaction time (RT), and response accuracy measures were obtained during the phonological and semantic categorization of spoken words in 14 undergraduates: 7 were average readers and 7 were reading-impaired. For the impaired readers, motor responses were significantly slower and less accurate than were those of the average readers in both classification tasks. ERPs obtained during rhyme processing displayed a relatively larger amplitude negativity at about 480 ms for the impaired readers as compared to the average readers, whereas semantic processing resulted in no major group differences in the ERPs at this latency. Also, N480 amplitude was larger during semantic relative to phonological classification for the average readers but not for the impaired readers. Results are compared to a previous study of reading-impaired children on the same tasks.

Predicting three mood phenomena from factors and facets of the NEO-PI.

The relationship between transient mood phenomena and enduring personality characteristics was studied. Eighty-one women completed the NEO Personality Inventory (Costa & McCrae, 1985) and provided daily unidimensional mood ratings for 20 days. Average mood was negatively related to Neuroticism (N) and positively related to Extraversion (E). More fine-grained analyses revealed that Positive Emotions, a facet of E, was a better predictor of average mood than was the overall E factor score. The greater a facet's loading on N or E, the better it predicted average mood. Within-day mood variability (mood fluctuation) was positively related to Openness to Experience (O), particularly to the facet, Fantasy. Across-day variability (mood swing) was positively related to both E and O. No relationship was found between any of the mood variables and Agreeableness (A) or Conscientiousness (C). The 3 mood variables were virtually independent of one another, but each showed moderately high temporal stability across the 4-week period.

Late cognitive brain potentials, phonological and semantic classification of spoken words, and reading ability in children.

Event-related potential (ERP), reaction time, and response accuracy measures were obtained during rhyming and semantic classification of spoken words in 10 average (mean age 11.64 years) and 9 impaired reading (mean age 12.10 years) children. The behavioral measures of classification did not distinguish the groups. In the ERPs, rhyme processing produced more pronounced group differences than did semantic processing at about 480 ms, with a relatively more negative distribution for the impaired readers at centroparietal sites. At about 800 ms in both classification tasks, the impaired readers displayed a late positivity that was delayed in latency and of larger amplitude at frontal sites than that for the average readers. The ERP findings suggest that the categorization of spoken words for meaning and sound result in increasingly more aberrant correlates of these processing demands in reading-impaired children.