Clinical Psychopharmacology & Drug Epidemiology
By Corrado Barbui
The main research interests of the Unit include: (a) pharmacoepidemiology, oriented to describe the beneficial and harmful effects of psychotropic drugs in ordinary practice; (b) randomized controlled trials, oriented to assess the efficacy and tolerability profile of psychotropic drugs in experimental conditions; (c) systematic reviews, oriented to summarize clinical trial findings using meta-analytical techniques. Recent achievements of the Unit include the development of a psychotropic register that collects information on psychotropic drugs prescribed within the South-Verona catchment area; the development of a network of psychiatric services that is currently recruiting patients for a multi-centre randomized controlled trial; the production of systematic reviews in the field of antidepressants and antipsychotics; and the development of tools oriented to assist the World Health Organization to improve the rational use of psychotropic drugs in low and middle income countries. The projects of the Unit are financially supported by organisations not linked with drug companies..
Dr. Corrado Barbui, Psychiatrist
Dr. Andrea Cipriani, Psychiatrist
Dr.ssa Michela Nosé , Psychiatrist
Dr.ssa Marianna Purgato, Psychologist, Phd Student
Dr.ssa Francesca Girlanda, Psychologist, Phd Student
CHAT (Clozapine, Haloperidol, Aripiprazole Trial) is a prospective, multicentre, randomized, parallel-group, superiority trial that compares the efficacy and tolerability of combination treatment with clozapine plus aripiprazole versus combination treatment with clozapine plus haloperidol in patients with schizophrenia who do not have an optimal response to clozapine. Consecutive patients with an incomplete response to treatment with clozapine over an appropriate period of time are randomly assigned to augmentation with aripiprazole or haloperidol. These patients constitute the randomised cohort. Patients with an incomplete response to treatment with clozapine over an appropriate period of time, who are not randomly assigned to competitive treatments, are followed under real-world circumstances. These patients constitute the observational cohort. In both the experimental and observational cohort patients and clinicians are not blind to pharmacological treatments provided during the trial. Withdrawal from allocated treatment within three months is the primary outcome. Secondary outcomes include severity of symptoms on the Brief Psychiatric Rating Scale (BPRS) and antipsychotic subjective tolerability on the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). The study is now concluded and statistical analysis to review the data are ongoing.
LAST- RD Study:
LAST-RD (Lithium And Standard Therapy in Resistant Depression) is a prospective, multicentre, randomized, parallel-group, superiority trial that will follow patients over a period of 12 months. Patients with treatment-resistant depression and risk of suicide will be randomly assigned to (i) lithium plus usual pharmacological and non-pharmacological treatment or to (ii) usual pharmacological and non-pharmacological treatment. Patients and clinicians will not be blind to pharmacological treatments provided during the trial. In order to limit the potential bias introduced by lack of blindness, an independent adjudicating committee, blind to treatment allocation, will validate the events that will constitute the primary outcome. Patients will be assessed at baseline before randomization and then every month after random allocation until the completion of the 12-month follow-up. All phases of the trial will be recorded following the CONSORT statement.
PERCEPTION OF ANTIPSYCHOTIC DRUGS
Almost no data are available on whether patients and doctors have similar or dissimilar opinions on the presence and level of distress of antipsychotic adverse effects. This project was therefore undertaken to compare doctors' versus patients' perspective on the presence and level of distress of antipsychotic adverse effects in a sample of patients under the care of the South-Verona mental health services. All patients exposed to antipsychotic drugs during a census period of 6 months were identified. For each included subject, socio-demographic, clinical and treatment data were extracted. Patients' perspective on antipsychotic adverse effects was measured by means of the Liverpool University Neuroleptic Side Effect Rating Scale (LUNSERS). The LUNSERS was similarly employed to measure doctors' perspective on antipsychotic adverse effects. During the recruitment period, more than 200 patients taking antipsychotic drugs were enrolled in the survey. Preliminary findings, which showed that the correlation between the total LUNSERS score reported by patients and doctors was very low, indicate that doctors, researchers and health care providers should increasingly consider patient and doctor perspectives as two complementary dimensions that may provide different insights in the evaluation of antipsychotic drugs.
LINKS AND DOWNLOAD
Ulteriori informazioni sullo studio CHAT:
Ulteriori informazioni sullo Studio Studio LAST: