Placebo-Controlled Pilot Study of Ramelteon for Adiposity and Lipids in Patients With Schizophrenia
ABSTRACT 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.
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.
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.
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.
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ABSTRACT: Individuals with serious mental illness have high rates of cardiovascular disease (CVD) risk factors and mortality. This systematic review was conducted to evaluate pharmacologic and behavioral interventions to reduce CVD risk in adults with serious mental illness.The Journal of Clinical Psychiatry 05/2014; 75(5):e424-e440. DOI:10.4088/JCP.13r08558 · 5.14 Impact Factor
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ABSTRACT: Objective: This open-label study examined the effects of ramelteon on cognitive functions in 10 outpatients with schizophrenia. Methods: Ramelteon (8 mg/day) was administered to 10 patients with schizophrenia for six months. The verbal fluency test, Trail-Making Test, the Wisconsin Card Sorting Test, the Stroop Test, the Digit Span Distraction Test, Iowa Gambling Task, the Rey Auditory Verbal Learning Test were evaluated at baseline and 6 months after treatment with ramelteon. Results: Ramelteon improved significantly the scores of Rey Auditory Verbal Learning Test. Additionally, ramelteon exerted im-provements in the verbal fluency and Iowa Gambling Task in 4 patients. Conclusion: Ramelteon could be a potential therapeutic drug, in adjunctive treatment of learning and memory deficits seen in patients with schizophrenia.Clinical Psychopharmacology and Neuroscience 12/2014; 12(3):2093-4327215. DOI:10.9758/cpn.2014.12.3.215