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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
36
Shafa Psychiatric Hospital
Rasht, Gilan Province, Iran
Change from baseline in weight at week eight
Time frame: Baseline and week eight
Change from baseline in Triglyceride at week 4
Time frame: Baseline and week 4
Change from baseline in HDL at week 4
Time frame: Baseline and week 4
Change from baseline in LDL at week 4
Time frame: Baseline and week 4
Change from baseline in Total Cholesterol at week 4
Time frame: Baseline and Week 4
Change from baseline in weight at week 4
Time frame: Baseline and week 4
Change from baseline in Fasting blood sugar at week 4
Time frame: Baseline and week 4
Change from baseline in blood pressure at week 4
Time frame: Baseline and week 4
Change from baseline in body mass index (BMI) at week 4
Time frame: Baseline and week 4
Change from baseline in waist to hip ratio at week 4
Time frame: Baseline and week 4
Change from baseline in Positive and negative syndrome scale (PANSS) at week 4
Time frame: Baseline and week 4
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Change from baseline in Positive and negative syndrome scale (PANSS) at week 8
Time frame: Baseline and week 8
Change from baseline in Triglyceride at week 48
Time frame: Baseline and week 8
Change from baseline in HDL at week 8
Time frame: Baseline and week 8
Change from baseline in LDL at week 8
Time frame: Baseline and week 8
Change from baseline in Total Cholesterol at week 8
Time frame: Baseline and Week 8
Change from baseline in Fasting blood sugar at week 8
Time frame: Baseline and week 8
Change from baseline in blood pressure at week 8
Time frame: Baseline and week 8
Change from baseline in body mass index (BMI) at week 8
Time frame: Baseline and week 8
Change from baseline in waist to hip ratio at week 8
Time frame: Baseline and week 8
Change from baseline in Insulin at week 8
Time frame: Baseline and week 8
Number of adverse events at the end of the study in each group
Time frame: Baseline, week 4, and 8
Changes from baseline in HOMA-IR values at week 8
Time frame: Baseline and week 8