Melatonin for Prevention of Metabolic Side Effects of Olanzapine

Sponsor

Guilan University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT01593774

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Melatonin Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Melatonin

Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week

Drug: Melatonin

Tablet melatonin 3 mg/day at 9 pm as intervention group

Placebo Comparator: Placebo

Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Drug: Placebo

Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Outcome Measures

Primary Outcome Measures

Change from baseline in weight at week eight [Baseline and week eight]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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