Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia
Christina P C Borba1, Xiaoduo Fan, Paul M Copeland
1Schizophrenia Program, Massachusetts General Hospital, Boston, MA, USA. cborba@partners.org
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.
Insights
Ramelteon did not improve weight or glucose control in schizophrenia patients but did lower cholesterol. Longer, higher-dose treatment may be needed to impact body fat and lipids.
Area of Science:
- Pharmacology
- Metabolic Disorders
- Schizophrenia Treatment
Background:
- Antipsychotic medications for schizophrenia often cause metabolic complications like obesity and hyperlipidemia.
- Few interventions effectively prevent or reverse these antipsychotic-induced metabolic disturbances.
- No single agent currently corrects multiple metabolic abnormalities simultaneously.
Purpose of the Study:
- To investigate the effects of ramelteon on obesity and metabolic disturbances in schizophrenia patients.
- To assess ramelteon's impact on body fat, glucose metabolism, and lipid profiles.
Main Methods:
- A randomized, double-blind, placebo-controlled, 8-week pilot study.
- Ramelteon 8 mg/day was added to stable antipsychotic treatment in outpatients with schizophrenia.
- Measurements included vital signs, anthropometrics, body composition (DEXA), and laboratory metabolic markers.
Main Results:
- Ramelteon did not significantly improve anthropometric measurements, glucose metabolism, or inflammatory markers.
- A significant decrease in total cholesterol and the cholesterol to HDL ratio was observed in the ramelteon group.
- Dual-energy x-ray absorptiometry showed a trend toward reduced abdominal and trunk fat with ramelteon.
Conclusions:
- Ramelteon demonstrated a cholesterol-lowering effect in schizophrenia patients over 8 weeks.
- Longer treatment duration and higher doses may be necessary to achieve significant changes in body fat and lipids.
- Further research with larger sample sizes is required to fully elucidate ramelteon's effects on adiposity and lipids in this population.
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