Olanzapine is an atypical antipsychotic drug which is widely used in psychiatric wards and has weight gain side effect. The aim of this study was to analyze the effect of ranitidine in prevention of olanzapine induced weight gain. It was a triple blind randomized clinical trial on the patients with thought disorder who was taking olanzapine. 60 patients entered the study considering the inclusion and exclusion criteria. Then, they were randomly assigned into intervention or comparison group. The intervention group was given 600 mg of ranitidine, daily made by Sobhan company along with olanzapine while the comparison group was given placebo with the same color, shape, and taste of ranitidine along with olanzapine for 16 weeks. Before and 16 weeks after intervention, the patients in both group weighted by weight scale (Kg) and ranitidine side effects were recorded weekly by drugs side effect questionnaire .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009112181N5
Registration date:2010-10-26, 1389/08/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-26, 1389/08/04
Registrant information
Name
Fatemeh Ranjbar Kouchaksaraei
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 6923
Email address
ranjbarf@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2008-03-20, 1387/01/01
Expected recruitment end date
2009-03-21, 1388/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of ranitidine in the prevention of olanzapine induced weight gain
Public title
The role of ranitidine in the prevention of weight gain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Taking olanzapine for thought disorder, Hospitalization for over 16 weeks, signing informed written consent
Exclusion criteria: The physical co-morbidity, Simultaneous taking of drugs with weight gain side effect, Special diets
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice chancellor for research of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht streat, Tabriz
City
Tabriz
Postal code
Approval date
empty
Ethics committee reference number
3992/4/5
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
E66.1
ICD-10 code description
Drug-induced obesity
2
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
3
Description of health condition studied
Schizoaffective disorders
ICD-10 code
F25
ICD-10 code description
Schizoaffective disorders
Primary outcomes
1
Description
body weight
Timepoint
Before and 16 weeks after intervention
Method of measurement
Weight Scale(kg)
Secondary outcomes
1
Description
ranitidine side effects
Timepoint
Weekly
Method of measurement
drugs side effects questionnaire
Intervention groups
1
Description
Intervention group: tab ranitidine 150mg, 4 tab per day, orally, for 16 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo with the same shape, size and taste, 4 tab, orally, for 16 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Razi Hospital
Full name of responsible person
Dr Fatemeh Ranjbar Kouchaksaraie
Street address
Razi Hospital, El goli road, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice chancellor for research
Street address
Tabriz University of Medical Sciences, Golgasht streat, Tabriz
City
Tabriz
Grant name
124/202
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Alireza Ghanepoor
Position
Psychiatrist
Other areas of specialty/work
Street address
Razi Hospital, El goli road, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1380 4486
Fax
Email
dr.ghanepoor@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Fatemeh Ranjbar Kouchaksaraie
Position
Psychiatrist, Associate professor
Other areas of specialty/work
Street address
Razi Hospital, El goli road, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1380 4486
Fax
Email
ranjbarf@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Siences
Full name of responsible person
Dr. Mahboob Asadlo
Position
Psychiaty resident
Other areas of specialty/work
Street address
Razi Hospital, El goli road, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1380 4486
Fax
Email
mahboobasadlo@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)