An open-label, multicenter observational study for patients with Alzheimer's disease treated with memantine in the clinical practice.

BACKGROUND/AIMS: In this post-marketing observational study, the safety and effectiveness of memantine were evaluated in patients with Alzheimer's disease (AD). METHODS: In a 6-month, observational, open-label study at 202 specialist sites in Greece, the effectiveness of memantine was evaluated using the Mini-Mental State Examination (MMSE) and the Instrumental Activities of Daily Living (IADL) scale at baseline, and after 3 and 6 months. Discontinuation rates and adverse drug reactions (ADRs) were also recorded to evaluate the safety profile of memantine. RESULTS: 2,570 patients participated in the study. Three and 6 months after baseline, MMSE and IADL scores were significantly improved compared to baseline. At the end of the study, 67% of the patients had improved their MMSE score; 7.1% of the patients reported ≥1 ADRs, and treatment was discontinued due to ADR in 0.7%. CONCLUSION: Memantine was well tolerated and had a positive effect on the patient's cognitive and functional ability in real-life clinical practice, in agreement with randomized, controlled trials.

Memantine in everyday clinical practice: a comparison of studies in Germany and Greece.

BACKGROUND/AIMS: Results from German and Greek non-interventional studies were compared to investigate possible differences concerning efficacy, tolerability and compliance between both countries. METHODS: In two open-label, multicentre, non-interventional studies, 4,305 patients with mild to severe Alzheimer's disease (AD) were treated with daily doses of 20 mg memantine for 6 months. Efficacy was assessed using the Mini-Mental State Examination (MMSE) and instrumental activities of daily living (IADL) scales. Safety and tolerability were recorded. RESULTS: After 6 months, the patients showed an improvement of their cognitive performance by 2 MMSE points compared to baseline (p < 0.001). MMSE values were improved in 67.4% of the patients, while 15.1% remained stable, and MMSE deteriorated in 17.5% only. The ability to perform IADL increased, as is indicated by lower values (baseline: 70.5; after 6 months: 66.6 points). Improvement of cognition and IADL was nearly identical in both countries. Treatment discontinuation was significantly more frequent in the Greek population, mainly due to non-adherence (9.4% of the safety population). 345 adverse events were recorded in 245 patients (6.3%), and they were significantly associated with country and age. CONCLUSION: The results correspond to those of clinical trials and support the efficacy and good tolerability of memantine in a realistic setting. Differences between the countries were observed regarding the baseline characteristics of patients (more female, older and more severe patients in Germany as well as less pretreatment with cholinesterase inhibitors) and regarding premature discontinuation and reported adverse drug reactions, which were both higher in Greece.

Escitalopram in clinical practice in Greece: treatment response and tolerability in depressed patients.

OBJECTIVE: To evaluate the effectiveness and tolerability of escitalopram (10-20 mg/day) in adult outpatients suffering from major depressive disorder in naturalistic settings. METHODS: An open-label, 3-month, surveillance study was conducted in 434 investigative sites in Greece enrolling 5175 patients. Clinical Global Impression-Severity (CGI-S) scale and patient-rated Sheehan Disability Scale (SDS) were used as efficacy measurements and treatment discontinuation rates due to adverse events was used to assess tolerability. RESULTS: Clinically significant improvement in CGI-S scores was recorded after 3 months. At baseline, patients reported marked or extreme disability for work (38%), social life (41%) and family life (37%), whereas after 3 months of treatment, 80.6%, 79.5% and 83.5% of patients indicated either no or mild disability, respectively. Escitalopram had good tolerability, demonstrated by a very low rate of discontinuations due to adverse events. CONCLUSION: In this large naturalistic study, escitalopram was well tolerated and improved both depressive symptoms and function.

Comparison of four scales measuring depression in schizophrenic inpatients.

Several scales have been used to diagnose and evaluate depression in schizophrenia. However, the association between different depression scales and between depression scales and negative symptoms has not been studied adequately. Sixty-four consecutively admitted schizophrenic patients to Eginition Hospital, Department of Psychiatry, Athens, were assessed on the following scales: the Calgary Depression Scale for Schizophrenia (CDSS), the Hamilton Depression Rating Scale (HDRS), the Expanded Brief Psychiatric Rating Scale-Depression subscale (EBPRS-D), the Positive and Negative Syndrome Scale-Depression subscale (PANSS-D) and the Negative Symptoms subscale (PANSS-N). The depression scales were found to be highly intercorrelated with the exception of the comparison between the EBPRS-D and the PANSS-D. Out of the four depression scales studied, only CDSS and EBPRS-D can discriminate between depression and a PANSS-Negative Symptoms subscale score or negative item scores.

The Greek version of the calgary depression scale for schizophrenia.

The aim of this study was to evaluate the reliability and validity, as well as the specificity, of the Greek version of the Calgary Depression Scale for Schizophrenia (CDSS). Schizophrenic inpatients consecutively admitted at the Eginition Hospital, University of Athens, were included in the study. Patients were assessed on admission using the CDSS, the Hamilton Depression Rating Scale (HDRS), the Positive and Negative Syndrome Scale (PANSS), the Rating Scale for Extrapyramidal Side Effects (RSESE), the Rating Scale for Drug-Induced Akathisia (RSDIA) and the Abnormal Involuntary Movement Scale (AIMS). The CDSS was found to have a high inter-rater reliability, as well as test-retest reliability or split-half reliability. The internal consistency of the CDSS was good (a=0.87). There were positive correlations between the CDSS and the HDRS, or the depression cluster of the PANSS. The mean score on the CDSS showed no significant correlations with that of the PANSS negative subscale (r=0.123); a negative but not significant correlation with that of the PANSS positive subscale (r=-0.036); a weak correlation with that of the PANSS general psychopathology subscale (r=0.218); and no significant correlations with that of the RSESE (r=0.197), the RSDIA (r=0.160) or the AIMS (r=0.031). Our results give further support to the reliability, the validity, and the specificity of the CDSS.