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J Psychiatr Res. 2014 Jun;53:133-40. doi: 10.1016/j.jpsychires.2014.02.013. Epub 2014 Feb 24.

Melatonin for prevention of metabolic side-effects of olanzapine in patients with first-episode schizophrenia: randomized double-blind placebo-controlled study.

Author information

1
Psychiatry and Psychology Research Center, Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: amirh899@gmail.com.
2
Department of Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran.
3
Department of Pharmacology, Guilan University of Medical Sciences, Rasht, Iran.
4
Department of Biostatistics, Guilan University of Medical Sciences, Rasht, Iran.
5
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.
6
Psychiatry and Psychology Research Center, Department of Psychiatry, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.
7
Department of Psychiatry, Shafa Hospital, Guilan University of Medical Sciences, Rasht, Iran. Electronic address: gmodaber@gums.ac.ir.

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 (

REGISTRATION NUMBER:

NCT01593774).

KEYWORDS:

Glucose; Lipid; Melatonin; Olanzapine; Schizophrenia; Weight gain

[Indexed for MEDLINE]

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