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The purpose of this study is to determine whether melatonin can prevent metabolic side effects of olanzapine such as weight gain, elevated glucose concentrations and lipid abnormalities.
Atypical antipsychotics including olanzapine are associated with significant metabolic side effects. Animal studies have suggested that melatonin might prevent some of the olanzapine-associated side effects. Melatonin is safe and is widely used as a sleep-promoting complement, and is not associated with side effects seen with other used drugs such as metformin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melatonin | Experimental | Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week |
|
| Placebo | Placebo Comparator | Placebo (with the same shape and taste as melatonin) at 9 pm as control group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Melatonin | Drug | Tablet melatonin 3 mg/day at 9 pm as intervention group |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in weight at week eight | Baseline and week eight |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Triglyceride at week 4 | Baseline and week 4 | |
| Change from baseline in HDL at week 4 | Baseline and week 4 | |
| Change from baseline in LDL at week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Jafar Modabbernia, MD | Guilan University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shafa Psychiatric Hospital | Rasht | Gilan Province | 55599-41939 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16710316 | Background | Raskind MA, Burke BL, Crites NJ, Tapp AM, Rasmussen DD. Olanzapine-induced weight gain and increased visceral adiposity is blocked by melatonin replacement therapy in rats. Neuropsychopharmacology. 2007 Feb;32(2):284-8. doi: 10.1038/sj.npp.1301093. Epub 2006 May 10. | |
| 21869685 | Background | Borba CP, Fan X, Copeland PM, Paiva A, Freudenreich O, Henderson DC. Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia. J Clin Psychopharmacol. 2011 Oct;31(5):653-8. doi: 10.1097/JCP.0b013e31822bb573. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D006949 | Hyperlipidemias |
| D006943 | Hyperglycemia |
| D015430 | Weight Gain |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Placebo |
| Drug |
Placebo (with the same shape and taste as melatonin) at 9 pm as control group |
|
| Baseline and week 4 |
| Change from baseline in Total Cholesterol at week 4 | Baseline and Week 4 |
| Change from baseline in weight at week 4 | Baseline and week 4 |
| Change from baseline in Fasting blood sugar at week 4 | Baseline and week 4 |
| Change from baseline in blood pressure at week 4 | Baseline and week 4 |
| Change from baseline in body mass index (BMI) at week 4 | Baseline and week 4 |
| Change from baseline in waist to hip ratio at week 4 | Baseline and week 4 |
| Change from baseline in Positive and negative syndrome scale (PANSS) at week 4 | Baseline and week 4 |
| Change from baseline in Positive and negative syndrome scale (PANSS) at week 8 | Baseline and week 8 |
| Change from baseline in Triglyceride at week 48 | Baseline and week 8 |
| Change from baseline in HDL at week 8 | Baseline and week 8 |
| Change from baseline in LDL at week 8 | Baseline and week 8 |
| Change from baseline in Total Cholesterol at week 8 | Baseline and Week 8 |
| Change from baseline in Fasting blood sugar at week 8 | Baseline and week 8 |
| Change from baseline in blood pressure at week 8 | Baseline and week 8 |
| Change from baseline in body mass index (BMI) at week 8 | Baseline and week 8 |
| Change from baseline in waist to hip ratio at week 8 | Baseline and week 8 |
| Change from baseline in Insulin at week 8 | Baseline and week 8 |
| Number of adverse events at the end of the study in each group | Baseline, week 4, and 8 |
| Changes from baseline in HOMA-IR values at week 8 | Baseline and week 8 |
| 22527998 | Background | Anderson G, Maes M. Melatonin: an overlooked factor in schizophrenia and in the inhibition of anti-psychotic side effects. Metab Brain Dis. 2012 Jun;27(2):113-9. doi: 10.1007/s11011-012-9307-9. Epub 2012 Apr 25. |
| 24607293 | Derived | Modabbernia A, Heidari P, Soleimani R, Sobhani A, Roshan ZA, Taslimi S, Ashrafi M, Modabbernia MJ. Melatonin for prevention of metabolic side-effects of olanzapine in patients with first-episode schizophrenia: randomized double-blind placebo-controlled study. J Psychiatr Res. 2014 Jun;53:133-40. doi: 10.1016/j.jpsychires.2014.02.013. Epub 2014 Feb 24. |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004700 | Endocrine System Diseases |
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |