Faculty Bibliography

BACKGROUND: Psychosis is present in 50% or more of patients with bipolar mania and is commonly evaluated in clinical research by means of the Positive and Negative Syndrome Scale (PANSS). The aim of the present analysis was to investigate the psychotic dimensions of bipolar disorder and its contributing symptoms based on a factor analysis of baseline PANSS scores and to compare them with those identified in studies of patients with schizophrenia and bipolar disorder. SAMPLING AND METHODS: Baseline data were analyzed from two 3-week, double-blind, placebo-controlled studies of risperidone monotherapy for acute mania associated with bipolar I disorder (n = 535). Inclusion criteria were a DSM-IV diagnosis of bipolar I disorder with manic features, with or without psychotic features, age > or =18 years, and mean baseline Young Mania Rating Scale scores > or =20. A principal component analysis of the 30 PANSS item scores of the 535 patients with a diagnosis of a manic episode at baseline was conducted. RESULTS: Five factors were extracted by the analysis: anxiety (13.4% of the variance), negative symptoms (12.3%), depression (10.5%), excitement (10.3%), and positive symptoms (8.7%). Similar factors, in particular the negative, excitement, and positive factors, have been identified in patients with schizophrenia. There was an absence of a cognitive factor supporting the notion that bipolar patients may present fewer cognitive symptoms. CONCLUSION: The results of the present analysis and those of other studies indicate similarities in psychotic symptom domains, as measured by the PANSS, in patients with bipolar mania and schizophrenia. Future analyses will address the effects of treatment on the identified factors

Objectives: This study aimed to demonstrate efficacy of once-daily extended release quetiapine fumarate (quetiapine XR) versus placebo in patients with acute schizophrenia. Methods: In this 6-week, randomized, double-blind study (5077IL/0041) patients were randomized to receive quetiapine XR (300, 600, or 800 mg/day), quetiapine fumarate immediate release (quetiapine IR) [300 or 600 mg/day], or placebo. Primary endpoint was change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Day 42. Secondary variables included PANSS response rate at Day 42 (>/=30% decrease in PANSS total score from baseline) and Clinical Global Impressions Severity (CGI-S) and Improvement (CGI-I) ratings. Safety assessments included adverse event (AE) reporting and laboratory measures. Results: Of 532 patients randomized, 222 (41.7%) completed the study. Improvements in PANSS total scores from baseline to Day 42 across treatment groups were: quetiapine XR 300 mg/day -5.01, 600 mg/day -13.01 and 800 mg/day -11.17, quetiapine IR 300 mg/day -9.42 and 600 mg/day -6.97, and placebo -5.19; the difference in change was statistically significant only for quetiapine XR 600 mg/day (p = 0.033). There were no statistically significant differences between active treatment groups and placebo for PANSS response rates. Several post hoc analyses were conducted to explain the study efficacy outcome but these were inconclusive. Quetiapine XR was generally well tolerated with the majority of AEs being mild or moderate in intensity and no unexpected AEs. Conclusions: Superior efficacy of quetiapine XR versus placebo in patients with schizophrenia was demonstrated for quetiapine XR 600 mg/day. The safety and tolerability profile of quetiapine XR was similar to that of quetiapine IR

We describe Clinical Trials System (CTS), an innovative EDC system utilizing data from existing hospital-based electronic databases that supports information gathering and storing for various clinical trials. The complexities of designing electronic clinical trials systems and their ideal features are outlined. CTS optimally utilizes existing electronic databases in a well-organized and easy-to-reference format. CTS is currently incorporated within a large psychiatric center, allowing easy sharing of information and data among multidisciplinary clinical and research teams

The aim of the study was to investigate transcultural differences between schizophrenia spectrum disorder patients who did or did not attempt suicide. DSM-IV schizophrenia (N=609) or schizoaffective disorder (N=371) patients who participated in the multicentre International Suicide Prevention Trial (InterSePT) were studied. Patients were sub-divided into 5 groups according to the different geographical regions of recruitment: North America (NA), Europe (EUR), East Europe (EEUR), South Africa (SAf), and South America (SA). The main lifetime clinical variables were compared, within each group, between attempters and non-attempters. The presence of comorbid substance abuse disorder and smoking was associated with suicide attempts in all the geographical groups considered (NA: chi(1)(2)=7.575, p<0.01 and chi(1)(2)=69.549, p<0.0001; EUR: chi(1)(2)=55.068, p<0.0001, and chi(1)(2)=48.431, p<0.0001; EEUR: chi(1)(2)=164.628, p<0.000, and chi(1)(2)=5.127, p<0.01; SA: chi(1)(2)=30.204, p<0.0001 and chi(1)(2)=11.710, p=0.001) except for SAf. For the other clinical variables various differences were found across the different groups. Variables related to suicide behavior were similar across the five groups investigated, with differences only in the age at the first suicide attempt (earlier in the NA sample) and the number of lifetime suicide attempts (higher in the NA sample). Results from this study show that, while some suicide-related clinical characteristics in schizophrenia patients are consistent worldwide suggesting the influence of stable biological traits, other variables may vary across different geographical areas suggesting environmental influences

OBJECTIVE: Primary negative symptoms are intrinsic to the pathology of schizophrenia and are associated with significant deficits in motivation, verbal and nonverbal communication, affect, and cognitive and social functioning. Overall, atypical antipsychotic medications have been found to be more efficacious than conventional antipsychotics in the treatment of negative symptoms, based on studies with acute patients. Results have been confounded by concomitant improvements in positive, depressive, and extrapyramidal symptoms. This 12-week, double-blind, controlled study aimed to examine the effects of the atypical antipsychotic olanzapine versus haloperidol on persistent, primary negative symptoms and neurocognitive functions in stable schizophrenic patients with the deficit syndrome and low levels of concomitant positive, depressive, and extrapyramidal symptoms. METHOD: Thirty-five patients with DSM-IV-TR schizophrenia and predominant negative symptoms were randomly assigned in a 12-week double-blind study to either olanzapine (15-20 mg/day) or haloperidol (15-20 mg/day). Patients taking haloperidol received additional blinded benztropine. Inclusion criteria were Positive and Negative Syndrome Scale (PANSS) negative score of >or=20, PANSS positive score < 20, and fulfilling the criteria for the Schedule for the Deficit Syndrome. The PANSS, Clinical Global Impressions, Hamilton Rating Scale for Depression (HAM-D), Simpson-Angus Scale, and Abnormal Involuntary Movement Scale were assessed at regular subsequent intervals. A neuropsychological battery examining declarative verbal learning memory, attention and processing speed, executive functioning, and simple motor functioning domains of cognition was assessed at baseline and endpoint. The study ran from September 1998 through May 2005. RESULTS: Clinical Results: There was a statistically significant difference for PANSS negative symptoms (F = 5.44, df = 1,15; p

PMID: 17388705

ISSN: 1555-2101

CID: 73068