tailieunhanh - Báo cáo y học: " Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizop"

Tuyển tập báo cáo các nghiên cứu khoa học quốc tế ngành y học dành cho các bạn tham khảo đề tài: Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizop | Baandrup et al. BMC Psychiatry 2011 11 160 http 1471-244X 11 160 BMC Psychiatry STUDY PROTOCOL Open Access Prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia a randomized clinical trial - the SMART trial protocol 1 1 2 1 3 3 3 Lone Baandrup Birgitte Fagerlund Poul Jennum Henrik Lublin Jane L Hansen Per Winkel Christian Gluud Bob Oranje1 and Birte Y Glenthoj1 Abstract Background Treatment of schizophrenia frequently includes prolonged benzodiazepine administration despite a lack of evidence of its use. It is often difficult to discontinue benzodiazepines because of the development of dependence. We aim to assess if melatonin can facilitate the withdrawal of prolonged benzodiazepine administration in patients with schizophrenia. Furthermore we aim to investigate the association of benzodiazepine dose reduction with the following clinically important variables sleep psychophysiology cognition social function and quality of life. Methods Design Randomized blinded two-armed parallel superiority trial. We plan to include 80 consenting outpatients diagnosed with schizophrenia or schizoaffective disorder 18-55 years of age treated with antipsychotic drug s and at least one benzodiazepine derivative for the last three months before inclusion. Exclusion criteria currently under treatment for alcohol or drug abuse aggressive or violent behavior known mental retardation pervasive developmental disorder dementia epilepsy terminal illness severe co morbidity inability to understand Danish allergy to melatonin lactose starch gelatin or talc hepatic impairment pregnancy or nursing or lack of informed consent. After being randomized to prolonged-release melatonin Circadin 2 mg daily or matching placebo participants are required to slowly taper off their benzodiazepine dose. The primary outcome measure is benzodiazepine dose at 6 months follow-up. Secondary outcome measures include sleep .

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