prolonged-release melatonin versus placebo for benzodiazepine discontinuation in patients with schizophrenia a randomized clinical trial - the smart trial protocolprolonged-release褪黑素的苯二氮卓类药物停药与安慰剂精神分裂症患者随机临床试验u2014u2014智能试验协议.pdfVIP

Baandrup et al. BMC Psychiatry 2011, 11:160 /1471-244X/11/160 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 consen