This six week randomized controlled clinical trial includes 60 patients with schizophrenia. They will randomly allocate into either aripiprazole or risperidone groups. The outcome of this trial is body mass index. It will be assessed at baselineو week 1, week 3, and week 7.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305233930N26
Registration date:2014-11-01, 1393/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-01, 1393/08/10
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-05-27, 1392/03/06
Expected recruitment end date
2015-02-19, 1393/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of aripiprazole versus risperidone on body mass index for treating schizophrenia, a randomized double blind controlled clinical trial
Public title
aripiprazole versus risperidone for treating schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with schizophrenia aged between 16 to 65 years old.
Exclusion criteria: serious uncontrolled medical condition such as hypothyroidism; pregnancy.
Age
From 16 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciecnes
Street address
Shiraz University of Medical Sceinces
City
Shiraz
Postal code
--
Approval date
2013-05-26, 1392/03/05
Ethics committee reference number
CT-P-92-5346
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Weight
Timepoint
baseline and at the end of this trial
Method of measurement
kilogram
2
Description
Height
Timepoint
Baseline and at the end of this trial
Method of measurement
Meter
Secondary outcomes
empty
Intervention groups
1
Description
Risperidone (up to 10 mg/day)
Category
Treatment - Drugs
2
Description
Aripiprazole (up to 30 mg/day)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Street address
Hafez Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Vice-chancellery of Research Affairs, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Medicine Student
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
Professor of Psychiatry
Other areas of specialty/work
Street address
Hafez Hospital
City
Shiraz
Postal code
--
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)