title: Melatonin for prevention of metabolic side-effects of olanzapine in patients with first-episode schizophrenia: randomized double-blind placebo-controlled study.
abstract: We aimed to determine the efficacy of melatonin 3 mg/day in prevention of olanzapine-induced metabolic side-effects. In a randomized double-blind placebo-controlled study, 48 patients with first-episode schizophrenia who were eligible for olanzapine treatment, were randomly assigned to olanzapine plus either melatonin 3 mg/day or matched placebo for eight weeks. Anthropometric and metabolic parameters as well as psychiatric symptoms using The Positive and Negative Syndrome Scale (PANSS) were assessed at baseline, week 4, and 8. Primary outcome measure was the change from baseline in weight at week 8. Data were analyzed using t-test, Mann-Whitney U test, and mixed-effects model. Thirty-six patients had at least one post-baseline measurement. At week eight, melatonin was associated with significantly less weight gain [mean difference (MD) = 3.2 kg, P = 0.023], increase in waist circumference [MD = 2.83 cm, P = 0.041] and triglyceride concentration [MD = 62 mg/dl, P = 0.090 (nearly significant)] than the placebo. Changes in cholesterol, insulin, and blood sugar concentrations did not differ significantly between the two groups. Patients in the melatonin group experienced significantly more reduction in their PANSS scores [MD = 12.9 points, P = 0.014] than the placebo group. No serious adverse events were reported. To summarize, in patients treated with olanzapine, short-term melatonin treatment attenuates weight gain, abdominal obesity, and hypertriglyceridemia. It might also provide additional benefit for treatment of psychosis. The study was registered in the ClinicalTrials.gov (
  
  
  BACKGROUND
  NCT01593774).
authors.affiliation: Psychiatry and Psychology Research Center, Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: amirh899@gmail.com.
authors.forename: Amirhossein
authors.initials: A
authors.lastname: Modabbernia
authors.affiliation: Department of Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran.
authors.forename: Parvaneh
authors.initials: P
authors.lastname: Heidari
authors.affiliation: Department of Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran.
authors.forename: Robabeh
authors.initials: R
authors.lastname: Soleimani
authors.affiliation: Department of Pharmacology, Guilan University of Medical Sciences, Rasht, Iran.
authors.forename: Abdolrasoul
authors.initials: A
authors.lastname: Sobhani
authors.affiliation: Department of Biostatistics, Guilan University of Medical Sciences, Rasht, Iran.
authors.forename: Zahra Atrkar
authors.initials: ZA
authors.lastname: Roshan
authors.affiliation: Psychiatry and Psychology Research Center, Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran; Department of Biostatistics, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Shervin
authors.initials: S
authors.lastname: Taslimi
authors.affiliation: Psychiatry and Psychology Research Center, Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Mandana
authors.initials: M
authors.lastname: Ashrafi
authors.affiliation: Department of Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: gmodaber@gums.ac.ir.
authors.forename: Mohammad Jafar
authors.initials: MJ
authors.lastname: Modabbernia
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000975:Antioxidants / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000009:adverse effects*; D001569:Benzodiazepines / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008055:Lipids / Q000097:blood; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D008659:Metabolic Diseases / Q000139:chemically induced* / Q000517:prevention & control*; D008875:Middle Aged; D000077152:Olanzapine; D012559:Schizophrenia / Q000188:drug therapy; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000975:Antioxidants; D014150:Antipsychotic Agents; D008055:Lipids; D001569:Benzodiazepines; D008550:Melatonin; D000077152:Olanzapine
keywords: Glucose; Lipid; Melatonin; Olanzapine; Schizophrenia; Weight gain