Melatonin for Prevention of Metabolic Side Effects of Olanzapine

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593774
• Other study ID #: GUMS-9277
• Status: Completed
• Phase: Phase 2
• First received: May 6, 2012
• Last updated: April 8, 2013
• Start date: May 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Guilan University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Melatonin
Tablet melatonin 3 mg/day at 9 pm as intervention group
• Placebo
Placebo (with the same shape and taste as melatonin) at 9 pm as control group

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shafa Psychiatric Hospital	Rasht	Guilan

Sponsors (1)

Lead Sponsor	Collaborator
Guilan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (3)

Anderson G, Maes M. Melatonin: an overlooked factor in schizophrenia and in the inhibition of anti-psychotic side effects. Metab Brain Dis. 2012 Jun;27(2):113-9. doi: 10.1007/s11011-012-9307-9. Epub 2012 Apr 25. Review. — View Citation

Borba CP, Fan X, Copeland PM, Paiva A, Freudenreich O, Henderson DC. Placebo-controlled pilot study of ramelteon for adiposity and lipids in patients with schizophrenia. J Clin Psychopharmacol. 2011 Oct;31(5):653-8. doi: 10.1097/JCP.0b013e31822bb573. — View Citation

Raskind MA, Burke BL, Crites NJ, Tapp AM, Rasmussen DD. Olanzapine-induced weight gain and increased visceral adiposity is blocked by melatonin replacement therapy in rats. Neuropsychopharmacology. 2007 Feb;32(2):284-8. Epub 2006 May 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in weight at week eight		Baseline and week eight	No
Secondary	Change from baseline in Triglyceride at week 4		Baseline and week 4	No
Secondary	Change from baseline in HDL at week 4		Baseline and week 4	No
Secondary	Change from baseline in LDL at week 4		Baseline and week 4	No
Secondary	Change from baseline in Total Cholesterol at week 4		Baseline and Week 4	No
Secondary	Change from baseline in weight at week 4		Baseline and week 4	No
Secondary	Change from baseline in Fasting blood sugar at week 4		Baseline and week 4	No
Secondary	Change from baseline in blood pressure at week 4		Baseline and week 4	No
Secondary	Change from baseline in body mass index (BMI) at week 4		Baseline and week 4	No
Secondary	Change from baseline in waist to hip ratio at week 4		Baseline and week 4	No
Secondary	Change from baseline in Positive and negative syndrome scale (PANSS) at week 4		Baseline and week 4	No
Secondary	Change from baseline in Positive and negative syndrome scale (PANSS) at week 8		Baseline and week 8	No
Secondary	Change from baseline in Triglyceride at week 48		Baseline and week 8	No
Secondary	Change from baseline in HDL at week 8		Baseline and week 8	No
Secondary	Change from baseline in LDL at week 8		Baseline and week 8	No
Secondary	Change from baseline in Total Cholesterol at week 8		Baseline and Week 8	No
Secondary	Change from baseline in Fasting blood sugar at week 8		Baseline and week 8	No
Secondary	Change from baseline in blood pressure at week 8		Baseline and week 8	No
Secondary	Change from baseline in body mass index (BMI) at week 8		Baseline and week 8	No
Secondary	Change from baseline in waist to hip ratio at week 8		Baseline and week 8	No
Secondary	Change from baseline in Insulin at week 8		Baseline and week 8	No
Secondary	Number of adverse events at the end of the study in each group		Baseline, week 4, and 8	Yes
Secondary	Changes from baseline in HOMA-IR values at week 8		Baseline and week 8	No