Schizophrenia
Conditions
Keywords
Melatonin, Olanzapine, Metabolic side effects, Psychosis, Hyperlipidemia, Hyperglycemia, Weight gain, Diabetes
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.
Interventions
DRUGMelatonin
Tablet melatonin 3 mg/day at 9 pm as intervention group
DRUGPlacebo
Placebo (with the same shape and taste as melatonin) at 9 pm as control group
Sponsors
Guilan University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in weight at week eight | Baseline and week eight |
Secondary
| Measure | 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 | 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 |
Countries
Iran
Outcome results
None listed