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Melatonin for Prevention of Metabolic Side Effects of Olanzapine

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Melatonin
Placebo
Sponsored by
Guilan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia focused on measuring Melatonin, Olanzapine, Metabolic side effects, Psychosis, Hyperlipidemia, Hyperglycemia, Weight gain, Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shafa Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change from baseline in weight at week eight

Secondary Outcome Measures

Change from baseline in Triglyceride at week 4
Change from baseline in HDL at week 4
Change from baseline in LDL at week 4
Change from baseline in Total Cholesterol at week 4
Change from baseline in weight at week 4
Change from baseline in Fasting blood sugar at week 4
Change from baseline in blood pressure at week 4
Change from baseline in body mass index (BMI) at week 4
Change from baseline in waist to hip ratio at week 4
Change from baseline in Positive and negative syndrome scale (PANSS) at week 4
Change from baseline in Positive and negative syndrome scale (PANSS) at week 8
Change from baseline in Triglyceride at week 48
Change from baseline in HDL at week 8
Change from baseline in LDL at week 8
Change from baseline in Total Cholesterol at week 8
Change from baseline in Fasting blood sugar at week 8
Change from baseline in blood pressure at week 8
Change from baseline in body mass index (BMI) at week 8
Change from baseline in waist to hip ratio at week 8
Change from baseline in Insulin at week 8
Number of adverse events at the end of the study in each group
Changes from baseline in HOMA-IR values at week 8

Full Information

First Posted
May 6, 2012
Last Updated
April 8, 2013
Sponsor
Guilan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01593774
Brief Title
Melatonin for Prevention of Metabolic Side Effects of Olanzapine
Official Title
Phase 2 Study of Melatonin Adjunct to Olanzapine for Prevention of Olanzapine-associated Metabolic Side Effects.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guilan University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Melatonin, Olanzapine, Metabolic side effects, Psychosis, Hyperlipidemia, Hyperglycemia, Weight gain, Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Melatonin
Arm Type
Experimental
Arm Description
Tablet melatonin 3 mg/day at 9 pm as intervention group for eight week
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (with the same shape and taste as melatonin) at 9 pm as control group
Intervention Type
Drug
Intervention Name(s)
Melatonin
Intervention Description
Tablet melatonin 3 mg/day at 9 pm as intervention group
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo (with the same shape and taste as melatonin) at 9 pm as control group
Primary Outcome Measure Information:
Title
Change from baseline in weight at week eight
Time Frame
Baseline and week eight
Secondary Outcome Measure Information:
Title
Change from baseline in Triglyceride at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in HDL at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in LDL at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in Total Cholesterol at week 4
Time Frame
Baseline and Week 4
Title
Change from baseline in weight at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in Fasting blood sugar at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in blood pressure at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in body mass index (BMI) at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in waist to hip ratio at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in Positive and negative syndrome scale (PANSS) at week 4
Time Frame
Baseline and week 4
Title
Change from baseline in Positive and negative syndrome scale (PANSS) at week 8
Time Frame
Baseline and week 8
Title
Change from baseline in Triglyceride at week 48
Time Frame
Baseline and week 8
Title
Change from baseline in HDL at week 8
Time Frame
Baseline and week 8
Title
Change from baseline in LDL at week 8
Time Frame
Baseline and week 8
Title
Change from baseline in Total Cholesterol at week 8
Time Frame
Baseline and Week 8
Title
Change from baseline in Fasting blood sugar at week 8
Time Frame
Baseline and week 8
Title
Change from baseline in blood pressure at week 8
Time Frame
Baseline and week 8
Title
Change from baseline in body mass index (BMI) at week 8
Time Frame
Baseline and week 8
Title
Change from baseline in waist to hip ratio at week 8
Time Frame
Baseline and week 8
Title
Change from baseline in Insulin at week 8
Time Frame
Baseline and week 8
Title
Number of adverse events at the end of the study in each group
Time Frame
Baseline, week 4, and 8
Title
Changes from baseline in HOMA-IR values at week 8
Time Frame
Baseline and week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohammad Jafar Modabbernia, MD
Organizational Affiliation
Guilan University of Medical Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Shafa Psychiatric Hospital
City
Rasht
State/Province
Guilan
ZIP/Postal Code
55599-41939
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16710316
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. doi: 10.1038/sj.npp.1301093. Epub 2006 May 10.
Results Reference
background
PubMed Identifier
21869685
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.
Results Reference
background
PubMed Identifier
22527998
Citation
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.
Results Reference
background
PubMed Identifier
24607293
Citation
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.
Results Reference
derived

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Melatonin for Prevention of Metabolic Side Effects of Olanzapine

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