Biomedical subjects

Corrado Barbui

Publications and source records attributed to Corrado Barbui.

77 records · Page 5Linked to original sources

PubMedDate not supplied

[A systemic review of the European Agency for the evaluation of medicinal products (EMEA) recommendations on the conduct of clinical trials in psychiatry].

OBJECTIVE: This article critically reviews the European Agency for the Evaluation of Medicinal Products (EMEA) recommendations on the conduct of clinical trials in psychiatry. The EMEA is a regulatory body which provides the institutions of the European Community with the best possible scientific advice on the quality, safety, and efficacy of medicinal products. METHOD: Systematic review of recommendations, guide-lines and official documents available in the EMEA web site. RESULTS: Out of nearly 400 documents, we identified 4 documents on the conduct of clinical trials in specific psychiatric disorders and 5 on the use of placebo or active comparator in evaluating a new drug's efficacy and on methodological issues in establishing difference and equivalence of effect. The EMEA recommends clinical trials to detect a difference between the compound under investigation and placebo, and to assess at least non-inferiority against an active comparator. A placebo arm is intended to validate the study. The EMEA supports the use of placebo only when there is no serious risk for the patient. In schizophrenia, depression and bipolar disorder the Agency suggests that a three-arm study is the design of choice, to demonstrate superiority against placebo and a similar balance against an active comparator. CONCLUSIONS: Despite the many effective therapeutic options available for the pharmacological management of psychiatric disorders, the EMEA regulatory process still relies on the demonstration of efficacy in absolute terms, against a placebo. We discuss this position and put at issue the possibility of developing a new generation of trials to demonstrate superiority of effect of new compounds over reference ones.

Humans↗

PubMedDate not supplied

Drug-induced depression: a systematic review to inform clinical practice.

BACKGROUND: Certain medications may contribute to the etiology of depressive symptoms and disorders. Research in this area, however, has been hampered by methodological and conceptual problems. This review had two objectives: to identify evidence linking medical drugs to depressive symptoms and disorders, and to summarize this evidence in a clinically meaningful way. METHODS: Electronic literature searches were performed and studies were reviewed with reference to critical methodological features. RESULTS: No medications causing the typical major depressive syndrome were identified. Evidence was found linking corticosteroids, interferon-alpha, interleukin-2, gonadotropin-releasing hormone agonists, mefloquine, progestin-releasing implanted contraceptives and propranolol to the etiology of atypical depressive syndromes. CONCLUSIONS: A small number of drugs have been shown capable of inducing depressive symptoms. Drug-induced depression appears to differ symptomatically from classical major depression.

Adrenal Cortex Hormones↗

PubMedDate not supplied

[Antidepressant and antipsychotic drug prescribing in Lombardy].

BACKGROUND: The patterns of antidepressant and antipsychotic drug prescribing have rarely been studied in large and geographically defined catchment areas. In the present study we examined the prevalence and distribution of antidepressant and antipsychotic prescribing in Lombardy, a northern Italy region of nine million inhabitants. METHODS: This study used the Regional Administrative Database of Lombardy. This database includes all prescriptions reimbursed by the National Health System in the population living in this region. All antidepressant and antipsychotic prescriptions dispensed from the 1st January to the 31st December 2001 were extracted and prevalence data calculated by dividing antidepressant and antipsychotic users by the total number of male and female residents in each age group. In addition, from the Regional database of hospital admissions we extracted all patients aged 65 or above with cerebrovascular-related outcomes for the year 2002. The two databases were linked anonymously with the aim of investigating the relationship between exposure to psychotropics and occurrence of cerebrovascular accidents in the elderly. RESULTS: During the study period 404,238 individuals were dispensed antidepressants, yielding a prevalence of use of 2.85 (95% CI 2.84, 2.87) per 100 males and 5.92 (95% CI 5.90, 5.94) per 100 females. The prevalence of use progressively rose with age in both sexes, with the highest rates in old and very old individuals. The majority of individuals received a pharmacological treatment with selective-serotonin reuptake inhibitors only, slightly more than 12% received a treatment with tricyclic antidepressants. A total of 86,187 subjects were dispensed antipsychotic agents, yielding a prevalence of use of 0.87 (95% CI 0.86, 0.88) per 100 males and 1.01 (95% CI 1.00, 1.02) per 100 females. The prevalence of use progressively rose with age in both sexes, with the highest rates in old and very old subjects. Concerning the relationship between exposure to second-generation antipsychotics (SGAs) and occurrence of cerebrovascular (CBV) accidents, the analysis showed a significantly increased risk of CBV events in elderly subjects exposed to SGAs in comparison with those exposed to first-generation antipsychotics (FGAs) (3,31%, 95% CI 2,95-3,69 vs. 2,37%, 95% CI 2,19-2,57). Finally the analysis indicated no differences in the proportion of cerebrovascular events in elderly subjects exposed to TCAs and SSRIs. CONCLUSIONS: The very high rates of antidepressant and antipsychotic drug prescribing detected in late life suggest the need of characterising these individuals in terms of medical and psychiatric characteristics, needs and quality of life. It also suggests the need for pragmatic clinical trials, carried out in the general practice, with the aim of assessing whether antidepressants are effective in these conditions. The data provide preliminary epidemiological evidence that exposure to SGAs, in comparison with exposure to FGAs, significantly increased the risk of cerebrovascular accidents in the elderly.

Adolescent↗

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Data Interpretation, Statistical↗

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Identification and management of depression in primary care settings. A meta-review of evidence.

AIM: The purpose of this review is to summarize the evidence base on the effectiveness of (a) screening for depression in primary care; (b) managing depression in primary care employing specific management strategies; (c) treating primary care depressive patients with antidepressants. METHODS: Meta-review of all available reviews of the evidence. RESULTS: Screening alone does not improve the recognition, management and outcome of depression in primary care settings. Management strategies, including (a) training primary care staff, (b) consultation-liaison, (c) collaborative care, (d) replacement/referral are supported by insufficient evidence to provide a definite answer as to the clinical effectiveness of individual models. Robust evidence exists to encourage physicians to prescribe effective doses of antidepressants in patients with moderate to severe depression who seek treatment in primary care settings. CONCLUSION: Population-level screening campaigns have a negative ratio of costs to benefits. However, at an individual-level of care increasing the ability of primary care physicians in recognising depression remains a relevant factor. Primary care physicians should consider whether depression is mild, moderate or severe. This patient categorisation help develop appropriate management and therapeutic strategies.

Depression↗