Melatonin for Prevention of Metabolic Side Effects of Olanzapine

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Melatonin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week | Drug: Melatonin<br>* Tablet melatonin 3 mg/day at 9 pm as intervention group<br>|
| Placebo Comparator: Placebo<br>Placebo (with the same shape and taste as melatonin) at 9 pm as control group | Drug: Placebo<br>* Placebo (with the same shape and taste as melatonin) at 9 pm as control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in weight at week eight |  | Baseline and week eight | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Melatonin, Olanzapine, Metabolic side effects, Psychosis, Hyperlipidemia, Hyperglycemia, Weight gain, Diabetes