Melatonin for Prevention of Metabolic Side Effects of Olanzapine

NCT01593774 | Completed Phase 2 DMC

• 1 other identifier: GUMS-9277
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Melatonin; Olanzapine; Metabolic side effects; Psychosis; Hyperlipidemia; Hyperglycemia; Weight gain; Diabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in weight at week eight

  Baseline and week eight

Secondary Outcomes (22)

• 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

Study Arms (2)

Melatonin

EXPERIMENTAL

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

Drug: Melatonin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Melatonin DRUG

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

Melatonin

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 year
• First episode schizophrenia (DSM-IV-TR)
• Ability to take medicine orally
• Eligible for starting olanzapine

You may not qualify if:

• 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

Sponsors & Collaborators

• Guilan University of Medical Sciences: lead

Study Sites (1)

Shafa Psychiatric Hospital

Rasht, Gilan Province, 55599-41939, Iran

Location

Related Publications (4)

• 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. doi: 10.1038/sj.npp.1301093. Epub 2006 May 10.

  PMID: 16710316 BACKGROUND

• 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.

  PMID: 21869685 BACKGROUND

• 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.

  PMID: 22527998 BACKGROUND

• Modabbernia A, Heidari P, Soleimani R, Sobhani A, Roshan ZA, Taslimi S, Ashrafi M, Modabbernia MJ. Melatonin for prevention of metabolic side-effects of olanzapine in patients with first-episode schizophrenia: randomized double-blind placebo-controlled study. J Psychiatr Res. 2014 Jun;53:133-40. doi: 10.1016/j.jpsychires.2014.02.013. Epub 2014 Feb 24.

  PMID: 24607293 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Hyperlipidemias; Hyperglycemia; Weight Gain; Diabetes Mellitus

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mohammad Jafar Modabbernia, MD

  Guilan University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry

Study Record Dates

• First Submitted: May 6, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 9, 2013

Record last verified: 2013-04

Locations

IR (1)