The aim of research is the study of efficacy of Anti-toxoplasma drugs in the treatment of schizophrenia . The method of research is randomized ,triple blind ,placebo controlled clinical trial. Study population are inpatient schizophrenic inpatient reffered to Amirkabir Hospital .
Inclusion criteria :informed written consent; diagnosis of schizophrenia according to DSMIV _TR criteria and clinical interview by psychiatrist; a score of at least 60 in PANSS; age range 15-55
Exclusion criteria: pregnancy; lactation ; substance abuse; severe physical disease; contraindication of cotrimoxazole
200 patients are randomly divided in 2 groups (intervention and control).Both groups recieve Risperidone 6 mg/day for 8 weeks .In addition to Risperidon ,intervention group recieve Cotrimoxazole 960 mg twice daily, and control group recieve placebo for 8 weeks .Primary outcome is change in PANSS scores .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201303287373N4
Registration date:2013-05-06, 1392/02/16
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-05-06, 1392/02/16
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 (Dr. Ashtiani)
Expected recruitment start date
2013-05-01, 1392/02/11
Expected recruitment end date
2013-10-01, 1392/07/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The efficacy of anti – toxoplasma drugs in the treatment of schizophrenia , a triple – blind, randomized , placebo-controlled clinical trial
Public title
The efficacy of anti – toxoplasma drugs in the treatment of schizophrenia , a triple – blind, randomized , placebo-controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria :informed written consent ;diagnosis of schizophrenia according to DSMIV _TR criteria and clinical interview by psychiatrist ;a score of at least 60 in PANSS;age range 15-55
Exclusion criteria: pregnancy ; lactation ;substance abuse; severe physical disease ; contraindication of cotrimoxazole
Age
From 15 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Approval date
2013-02-06, 1391/11/18
Ethics committee reference number
92-143-2
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 2 weeks
Method of measurement
clinical examination
Secondary outcomes
1
Description
extrapyramidal and skin side effects
Timepoint
befor intervention and every 2 weeks
Method of measurement
clinical examination
Intervention groups
1
Description
Intervention group receive risperidone 6 mg/day plus cotrimoxazole 960 mg twice daily for 8 weeks .
Category
Treatment - Drugs
2
Description
Control group receive risperidone 6 mg/day plus placebo for 8 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 of Medical Sciences
Full name of responsible person
Dr. Ashtiani
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 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
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
Amiakabir Hospital
City
Arak
Postal code
Phone
+98 8619181615442
Fax
Email
mjamilian@yahoo.com
Web page address
Person responsible for scientific 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
Phone
+98 86 1313 4715
Fax
Email
mjamilian@yahoo.com
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
board of psychiatry ,assistant professor
Other areas of specialty/work
Street address
Amirkabir Hospital
City
Arak
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)