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An assessment of effects of melatonin on metabolic effects of olanzapine in patients with schizophrenia

Protocol summary

Summary
The purpose of this study is to assess the efficacy of melatonin in prevention of olanzapine-induced metabolic side effect in patients with schizophrenia. Forty patients with schizophrenia based on DSM-IV-TR criteria who are not pregnant or lactating and have no significant medical illness will be randomly assigned to treatment for 12 weeks with olanzapine, 15- 25 mg/day, plus melatonin, 3mgs(N=20), or olanzapine, 15-25 mg/day, plus placebo (N=20). This investigation will be conducted in a double-blind fashion. Planned assessments included blood pressure, body weight, body mass index,waist circumference, waist-to-hip ratio, fasting glucose and insulin, insulin resistance index at baseline,week 4,8 &12, and fasting lipids.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107187049N1
Registration date: 2011-09-10, 1390/06/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-09-10, 1390/06/19
Registrant information
Name
Mohamadjafar Modabernia
Name of organization / entity
Guilan Univercity of Medical Sciences,Shafa hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 2360
Email address
gmodaber@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical sciences
Expected recruitment start date
2011-08-06, 1390/05/15
Expected recruitment end date
2012-05-04, 1391/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An assessment of effects of melatonin on metabolic effects of olanzapine in patients with schizophrenia
Public title
An assessment of effects of melatonin on metabolic effects of olanzapine in patients with schizophrenia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: age 18-65 year؛diagnosis of schizophrenia based on DSM-IV-TR؛ capability to take drugs at 9.00 pm Exclusion criteria: married women who are at reproductive age; history of drug abuse or dependence in the recent 30 days;history of taking olanzapine in the recent 3 months;history of allergy or intolerance to olanzapine; history of significant head trauma ( causing loss of concioussness more than 5 minutes or neurolgical or cognitive sequels);liver, kidney, cerebrovascular or cardiovascular disease;diabetes;metabolic syndrome; cancer ;using antiepileptic , antihypertensive or anticoagulant or anti-platelet drugs; using inhibitors or stimulants of hepatic isoenzymes that metabolize melatonin or olanzapine (e.g. omeprazole. rifampin, fluvuxamine, ciprofloxacin, carbamazepine, and modafinil) ; patients develop diabetes; acidosis; severe anticholinergic side effects; delirium or need for administration of another drug
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Guilan University of Medical sciences
Street address
Namjoo street,Rasht
City
Rasht
Postal code
41446-65385
Approval date
2011-07-05, 1390/04/14
Ethics committee reference number
190015211

Health conditions studied

1

Description of health condition studied
schizophrenia
ICD-10 code
F20-f29
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders

Primary outcomes

1

Description
TRIGLYCERIDE
Timepoint
baseline,week 4,8,12
Method of measurement
Enzymatic procedure

2

Description
waist cicumference
Timepoint
baseline,week 4,8,12
Method of measurement
with a plastic meter

3

Description
body mass index
Timepoint
baseline,week 4,8,12
Method of measurement
calculated as body weight(kg)divided by the height in meters square

4

Description
waist to hip ratio
Timepoint
baseline,week 4,8,12
Method of measurement
with a plastic meter

5

Description
LDL
Timepoint
baseline,week 4,8,12
Method of measurement
Enzymatic procedure

6

Description
HDL
Timepoint
baseline,week 4,8,12
Method of measurement
Enzymatic Procedure

7

Description
FBS
Timepoint
baseline,week 4,8,12
Method of measurement
Enzymatic Procedure

8

Description
Insulin resistance index
Timepoint
baseline and at the end of intervention
Method of measurement
with HOMA formula

9

Description
Fasting serum Insulin values
Timepoint
baseline and at the end of intervention
Method of measurement
ELISA

10

Description
Blood pressure
Timepoint
baseline,week 4,8,12
Method of measurement
mercury sphygmomanometer

Secondary outcomes

1

Description
improvement of sleep problems
Timepoint
base,week 4,8,12
Method of measurement
pittsburgh quality of sleep

2

Description
severity of psychosis
Timepoint
baseline,week 4,8,12
Method of measurement
scale measurement by PANSS

Intervention groups

1

Description
tablet melatonin 3mg at 9 pm as intervention group
Category
Placebo

2

Description
placebo at 9 pm as contol group
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Shafa hospital. Guilan University of Medical Sciences
Full name of responsible person
Amirhossein Modabbernia
Street address
Shafa hospital, Toshiba square, Rasht
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan University of Medical ScienceS
Full name of responsible person
Dr Abdolrasul Sobhani
Street address
Namjoo street
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical ScienceS
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Mohamadjafar Modabernia
Position
Psychiatrist
Other areas of specialty/work
Street address
Shafa hospital, Toshiba square, Rasht
City
Rasht
Postal code
55599-41939
Phone
+98 11316662325
Fax
Email
jafar_modabbernia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Mohamad Jafar Modabbernia
Position
Psychiatrist
Other areas of specialty/work
Street address
Shafa hospital, Toshiba square, Rasht
City
Rasht
Postal code
Phone
+98 13 1666 2325
Fax
Email
gmodaber@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr.Parvaneh Heidari Rad
Position
Psychiatry resident
Other areas of specialty/work
Street address
Shafa hospital, Toshiba square,Rasht
City
Rasht
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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