Zonisamide for prevention of Atypical (Second generation) antipsychotics associated weight gain in schizophrenia : A double- blind, placebo controlled trial
This is a double- blind, randomized placebo controlled trial to investigate the possible effect of zonisamide on prevention of weight gain in patients with schizophrenia taking atypical antipsychotics. The participants are 56 patients that they will be allocated to one of the two parallel groups. One group takes zonisamide (up to 150 mg/day) plus antipychotics. The other group will receive antipsychotic plus placebo. Duration of this study is 10 weeks. Assessment includes evaluation of height, weight, and waist circumference. The patients will be assessed at pre-intervention, week 4, week 8, and week 10 after intervention onset. Patients with schizophrenia administered atypical antipsychotics are included. Those with a marked medical condition will be excluded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103283930N5
Registration date:2011-07-13, 1390/04/22
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-07-13, 1390/04/22
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
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2011-03-28, 1390/01/08
Expected recruitment end date
2012-03-27, 1391/01/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Zonisamide for prevention of Atypical (Second generation) antipsychotics associated weight gain in schizophrenia : A double- blind, placebo controlled trial
Public title
Zonisamide for prevention of Atypical (Second generation) antipsychotics associated weight gain in schizophrenia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria are: age range of 16 to 65; lack of any reported neurological disease; lack of reported thyroid function problem; lack of current active substance use; lack of taking medication leading to significant weight gain or loss; no taking sulfanomides; lack of self reported kidney stone. Exclusion criteria are: lack of providing written consent; any serious medical condition such as epilepsy, thyroid function problems, diabetes; breast feeding; pregnancy; any special nutritional regime or intensive exercise program to decease weight.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
56
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
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice-chancellery for Research, Shiraz University of Medical sciences, Zand Street
City
Shiraz
Postal code
Approval date
2011-03-15, 1389/12/24
Ethics committee reference number
Ct-89-5460
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
hight
Timepoint
preintervention, weeks of 4, 8, and 10
Method of measurement
centimeter
2
Description
Weight
Timepoint
preintervention, weeks of 4, 8, and 10
Method of measurement
kilogram
3
Description
waist circumference
Timepoint
preintervention, weeks of 4, 8, and 10
Method of measurement
Centimeter
Secondary outcomes
empty
Intervention groups
1
Description
Zonisamide (150mg/day), Single dosage
Category
Treatment - Drugs
2
Description
Placeb
Category
Placebo
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
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Zand Street, Shiraz University of Medical sciences- Vice-chancellery for Research
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
Chamran street, 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)