Melatonin for Prevention of Metabolic Side Effects of Olanzapine
- Registration Number
- NCT01593774
- Lead Sponsor
- Guilan University of Medical Sciences
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
Inclusion Criteria
- Age 18-65 year
- First episode schizophrenia (DSM-IV-TR)
- Ability to take medicine orally
- Eligible for starting olanzapine
Exclusion Criteria
- Married women who are at reproductive age
- History of taking olanzapine in the recent 3 months
- History of allergy or intolerance to olanzapine
- History of significant head trauma ( causing loss of consciousness more than 5 minutes or neurological or cognitive sequels)
- Liver, kidney, cerebrovascular or cardiovascular disease
- Diabetes, metabolic syndrome
- Cancer
- Using antiepileptic (other than benzodiazepines for sleep) , antihypertensive, anticoagulant, anti-platelet drugs
- Using inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g. omeprazole. rifampin, fluvoxamine, ciprofloxacin, carbamazepine, modafinil)
- Delirium
- Need for administration of other antipsychotics
- Substance abuse
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo (with the same shape and taste as melatonin) at 9 pm as control group Melatonin Melatonin Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week
- Primary Outcome Measures
Name Time Method Change from baseline in weight at week eight Baseline and week eight
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Shafa Psychiatric Hospital
🇮🇷Rasht, Guilan, Iran, Islamic Republic of