Depressive Syndromes Associated with Alcohol Dependence.

OBJECTIVE: Depressive syndromes (DSs) are some of the most common mental disorders in individuals suffering from alcohol dependence (AD). The aim of the study was to investigate the characteristics of DSs associated with AD in a group of inpatients admitted in a psychiatric hospital. METHOD: One hundred sixty inpatients between 25 and 58 years of age (mean ± SD: 37.30 ± 7.97), suffering from AD and DSs and recruited from a larger clinical sample, were included. They were evaluated by means of a battery of diagnostic/rating scales for assessment of both diagnosis and symptoms severity. RESULTS: Complete physical and psychiatric examinations of AD patients showed that DSs represent a very heterogeneous group that can be divided in: psychogenic (66.3%), endogenous (11.3%), organic (22.4%), and mixed. The following clinical depressive subtypes could be identified: hypochondriac (42.5%), asthenic (20.6%), agitated (19.4%), dysphoric (8.8%), simple (4.35%), and apathetic (4.35). CONCLUSIONS: Our study indicates that DSs during AD represent a constant association that frequently complicates the clinical pictures, induces low quality of life and personal adjustment, and impairs remission. Investigation of the casual and intertwined factors, developmental patterns and clinical structure of the AD-associated DSs should allow optimizing a tailored and integrated system of medical rehabilitation help.

Efficacy and safety of a once-daily formulation of Ginkgo biloba extract EGb 761 in dementia with neuropsychiatric features: a randomized controlled trial.

OBJECTIVE: To test the efficacy and safety of a once-daily formulation of EGb 761 in the treatment of patients with dementia with neuropsychiatric features. METHODS: Multi-centre trial of 410 outpatients with mild to moderate dementia (Alzheimer's disease, vascular dementia or mixed form) scoring between 9 and 23 on the SKT cognitive test battery, at least five on the Neuropsychiatric Inventory (NPI) and three or higher in at least one item of the NPI. Patients were randomly allocated to double-blind treatment with 240 mg of EGb 761 or placebo once daily for 24 weeks. Primary outcomes were the changes from baseline in the SKT total score and the NPI total score. The Alzheimer's Disease Cooperative Study Clinical Global Impression of Change (ADCS-CGIC), Activities of Daily Living International Scale (ADL-IS), NPI distress score, DEMQOL-Proxy quality-of-life scale and Verbal Fluency Test were secondary outcomes. RESULTS: At endpoint, patients treated with EGb 761 (n = 202) improved by -1.4 (95% confidence interval -1.8; -1.0) points on the SKT and by -3.2 (-4.0; -2.3) on the NPI total score, whereas those receiving placebo (n = 202) deteriorated by +0.3 (-0.1; 0.7) on the SKT and did not change on the NPI total score (-0.9; 0.9). Both drug-placebo comparisons were significant at p < 0.001. EGb 761 was significantly superior to placebo with respect to all secondary outcome measures. Adverse event rates were similar for both treatment groups. CONCLUSIONS: EGb 761, 240 mg once-daily, was found significantly superior to placebo in the treatment of patients with dementia with neuropsychiatric symptoms.

Premorbid functioning and treatment response in recent-onset schizophrenia: prospective study with risperidone long-acting injectable.

Premorbid functioning may be associated with treatment response, but this is confounded by a lack of prospective longitudinal data and controls for medication compliance. This study tested the hypothesis that good premorbid functioning will be associated with better antipsychotic treatment response after controlling for drug adherence by using a long-acting injectable antipsychotic. This was a 6-month, open label, multicenter, phase IV trial in recent-onset schizophrenia treated with flexible doses of risperidone long-acting injectable (25-50 mg every 14 days). Premorbid functioning was assessed with the Premorbid Adjustment Scale (PAS)-Structured Interview; efficacy was evaluated with clinician-rated Positive and Negative Syndrome Scale, Clinical Global Impression scale of Severity of Illness, Clinical Global Impression scale of Change, Global Assessment of Functioning Scale, and trial participant completed SF-36. Analyses controlled for baseline scores and demographics. With the use of a priori PAS scoring criteria, the participants' premorbid functioning was categorized as stable-good (n = 142), stable-poor (n = 116), and deteriorating (n = 36). At baseline, the stable-good group had the best functioning on most efficacy measures. All groups showed significant improvement on efficacy measures with treatment. Improvement was significantly higher for the stable-good group. The PAS global assessment of highest level of functioning scale (excellent, n = 75; good, n = 117; fair, n = 78; and poor, n = 31) showed a strong association with baseline functioning and improvement and had a significant linear association with meeting Remission in Schizophrenia Working Group symptom criteria at baseline (P = 0.003) and attained and sustained remission for 3 months during study (47.7%, 49.3%, 29.6%, and 22.2%; P = 0.006). Good premorbid functioning corresponds with better treatment response in recent-onset psychosis as captured on both clinician and patient-reported measures.

Efficacy and tolerability of Ginkgo biloba extract EGb 761 by type of dementia: analyses of a randomised controlled trial.

Secondary analyses of a randomised controlled trial were performed to find out whether treatment effects of Ginkgo biloba extract EGb 761 differed by type of dementia. Three hundred ninety-five patients aged 50 years or above, with dementia with neuropsychiatric features were treated with EGb 761 (240 mg/day) or placebo for 22 weeks. Patients scored between 9 and 23 on the Short Syndrome Test (SKT), a cross-culturally validated cognitive test battery. Their total score on the Neuropsychiatric Inventory (NPI) was at least 5. Efficacy was assessed by the SKT test battery (primary outcome measure), the Verbal Fluency Test, the Clock-Drawing Test, the NPI, the Hamilton Rating Scale for Depression (HAMD), and the Gottfries-Bråne-Steen Scale (GBS). Applying standard research diagnostic criteria 214 patients were diagnosed with Alzheimer's disease (probable AD or possible AD with cerebrovascular disease) and 181 with probable vascular dementia (VaD). Under EGb 761 treatment the SKT total score improved by -3.0+/-2.3 and -3.4+/-2.3 points in patients with AD and VaD, respectively, whereas the patients on placebo deteriorated by +1.2+/-2.5 and +1.5+/-2.2 points, respectively (p<0.01 for both drug-placebo differences). Significant drug-placebo differences were found for all secondary outcome variables with no major differences between AD and VaD subgroups. The rate of adverse events tended to be higher for the placebo group.

Effects of Ginkgo biloba extract EGb 761 on neuropsychiatric symptoms of dementia: findings from a randomised controlled trial.

In a randomised, double-blind, 22-week trial 400 patients with dementia associated with neuropsychiatric features were treated with Ginkgo biloba extract EGb 761 (240 mg/day) or placebo. Patients with probable Alzheimer's disease, possible Alzheimer's disease with cerebrovascular disease or vascular dementia were eligible if they scored 9 to 23 on the SKT cognitive test battery and at least 5 on the Neuropsychiatric Inventory (NPI). EGb 761 was significantly superior to placebo with respect to the primary (SKT test battery) and all secondary outcome variables. The mean composite score (frequency x severity) and the mean caregiver distress score of the NPI dropped from 21.3 to 14.7 and 13.5 to 8.7, respectively, in the EGb 761-treated patients, but increased from 21.6 to 24.1 and 13.4 to 13.9, respectively, under placebo (p < 0.001). The largest drug-placebo differences in favour of EGb 761 were found for apathy/indifference, anxiety, irritability/lability, depression/dysphoria and sleep/nighttime behaviour.

Ginkgo biloba special extract in dementia with neuropsychiatric features. A randomised, placebo-controlled, double-blind clinical trial.

BACKGROUND: In previous trials of the Ginkgo biloba special extract EGb 761 improvements in cognitive functioning and behavioural symptoms were found in patients with aging-associated cognitive impairment or dementia. This trial was undertaken to assess the efficacy of EGb 761 in mild to moderate dementia with neuropsychiatric features. METHODS: Double-blind trial including 400 patients aged 50 years or above with Alzheimer's disease (AD) or vascular dementia (VaD), randomized to receive EGb 761 or placebo for 22 weeks. Patients scored below 36 on the Test for the Early Detection of Dementia with Discrimination from Depression (TE4D), between 9 and 23 on the SKT test battery and at least 5 on the Neuropsychiatric Inventory (NPI). RESULTS: There was a mean -3.2-point improvement in the SKT upon EGb 761 treatment and an average deterioration by +1.3 points on placebo (p < 0.001, two-sided, ANOVA). EGb 761 was significantly superior to placebo on all secondary outcome measures, including the NPI and an activities-of-daily-living scale. Treatment results were essentially similar for AD and VaD subgroups. The drug was well tolerated; adverse events were no more frequent under drug than under placebo treatment. CONCLUSION: The data add further evidence on the safety and efficacy of EGb 761 in the treatment of cognitive and non-cognitive symptoms of dementia.