The aim of research is the study of Topiramate in the treatment of schizophrenia .Method of research is randomized ,triple blind ,placebo controlled clinical trial .Study population are inpatient and outpatient schizophrenic patients reffered to Amirkabir Hospital and Imamreza clinic .
Inclusion criteria:age range 15-50 ;diagnosis of schisophrenia according to DSM4-TR criteria and clinical interview by psychiatrist ; informed written consent letter; a score of at least 60 in PANSS
Exclusion criteria :pregnancy;lactation; substance abuse;severe physical disease;epilepsy;use of Antiepileptic drugs ;contraindication of Topiramate
Patients are randomly divided in two groups (intervention and control).Each group recieve an atypical antipsychotic for 12 weeks .In addition to antipsychotic ,intervention group recieve Topiramate 200mg/day ,and control group recieve placebo.The time of intervention is 12 weeks from the start date.Primary outcome is change in PANSS scores.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303287373N3
Registration date:2013-04-08, 1392/01/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-08, 1392/01/19
Registrant information
Name
Hamidreza Jamilian
Name of organization / entity
Arak University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1222 5758
Email address
jamilian.hr@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak university of Medical Sciences vice president of education and research
Expected recruitment start date
2013-03-20, 1391/12/30
Expected recruitment end date
2013-09-23, 1392/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Topiramate in the treatment of Schizophrenia
Public title
Efficacy of Topiramate in the treatment of Schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:age range 15-50 ;diagnosis of schisophrenia according to DSM4-TR criteria and clinical interview by psychiatrist ; informed written consent letter; a score of at least 60 in PANSS
Exclusion criteria :pregnancy;lactation; substance abuse;severe physical disease;epilepsy;use of Antiepileptic drugs ;contraindication of Topiramate
Age
From 15 years old to 50 years old
Gender
Both
Phase
3
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
Arak University of Medical Sciences
Street address
basij square
City
Arak
Postal code
3819691187
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
15-141-91
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
PANSS
Timepoint
before intervention and every 4 weeks
Method of measurement
clinical examination
Secondary outcomes
1
Description
extrapyramidal side effects
Timepoint
before intervention and every 4 weeks
Method of measurement
clinical examination
Intervention groups
1
Description
Intervention group recieve an atypical antipsychotic(equivalent to Olanzapine 20 mg/day) plus Topiramate 200 mg/day for 12 weeks .
Category
Treatment - Drugs
2
Description
Control group recieve an atypical antipsychotic(equivalent to Olanzapine 20 mg/day) plus placebo for 12 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Hamidreza Jamilian
Street address
Amirkabir Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University Medical of Sciences
Full name of responsible person
Dr.Ashtiany
Street address
Basij square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University Medical of 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
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Jamilian
Position
Board of Psychiatry,Assistant professor
Other areas of specialty/work
Street address
Amirkabir Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 31 32518
Email
jamilian.hr@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak Unicesversity of Medical Sciences
Full name of responsible person
Hamidreza Jamilian
Position
Board of Psychiatry
Other areas of specialty/work
Street address
Basij square
City
Arak
Postal code
3819691187
Phone
+98 86 1417 3536
Fax
+98 31 32518
Email
jamilian.hr@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Hamidreza Jamilian
Position
Assistant professor .Board of Psychiatry
Other areas of specialty/work
Street address
Amirkabir Hospital
City
Arak
Postal code
3819691187
Phone
+98 86 1313 5075
Fax
+98 31 32518
Email
mjamilian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)