title: Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia.
abstract: OBJECTIVE
  Few interventions have been successful to prevent or reverse the medical complications associated with antipsychotic agents in the schizophrenia population. In particular, no single agent can correct multiple metabolic abnormalities such as insulin resistance, hyperlipidemia, inflammation, obesity, and fat distribution. We now report a randomized placebo-controlled pilot study to examine the effects of ramelteon on obesity and metabolic disturbances among subjects with schizophrenia.
  
  
  METHODS
  A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/d to stable outpatients with schizophrenia. Vital signs and anthropometric measurements, including height, weight, waist circumference, and body fat were assessed, and laboratory assays were tracked to monitor changes in metabolic markers.
  
  
  RESULTS
  Twenty-five subjects were randomly assigned to treatment with study drug or placebo, and 20 subjects were included in the final analysis. Ramelteon did not improve anthropometric measurements, glucose metabolism, and inflammatory markers. There was, however, a significant decrease in total cholesterol and ratio of cholesterol to high-density lipoprotein in the ramelteon group. Although the standard anthropometric measures did not show significant change, the dual-energy x-ray absorptiometry scan showed a trend toward reduction in fat in the abdominal and trunk areas with a moderate effect size.
  
  
  CONCLUSIONS
  Although ramelteon decreased cholesterol, treatment may have to be longer than 8 weeks and with a higher dose for maximal effect of ramelteon for body fat and lipid changes. Future studies are needed for patients with schizophrenia with a larger sample size to fully understand ramelteon's effects on abdominal adiposity and lipids.
authors.affiliation: Schizophrenia Program, Massachusetts General Hospital, Boston, MA, USA. cborba@partners.org
authors.forename: Christina P C
authors.initials: CP
authors.lastname: Borba
authors.forename: Xiaoduo
authors.initials: X
authors.lastname: Fan
authors.forename: Paul M
authors.initials: PM
authors.lastname: Copeland
authors.forename: Alexander
authors.initials: A
authors.lastname: Paiva
authors.forename: Oliver
authors.initials: O
authors.lastname: Freudenreich
authors.forename: David C
authors.initials: DC
authors.lastname: Henderson
mesh_terms: D050154:Adiposity / Q000187:drug effects*; D000293:Adolescent; D000328:Adult; D000368:Aged; D000886:Anthropometry; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007192:Indenes / Q000494:pharmacology*; D008055:Lipids / Q000097:blood; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000139:chemically induced / Q000188:drug therapy*; D010865:Pilot Projects; D012559:Schizophrenia / Q000188:drug therapy; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D007192:Indenes; D008055:Lipids; C495910:ramelteon