The objective of this triple blind randomized clinical trial research is the study of Aspirin efficacy in the treatment of schizophrenia. In this study, 60 schizophrenic patients meeting inclusion and exclusion criteria are randomly assigned into intervention or control group. The patients of intervention group receive Aspirin 1000mg/day while in control group they receive placebo with the same dose and form. PANSS scores will be assessed and compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201108197373N1
Registration date:2011-10-17, 1390/07/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-10-17, 1390/07/25
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
2011-10-23, 1390/08/01
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Aspirin in the treatment of schizophrenia
Public title
Efficacy of Aspirin in the treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age range 15-55, diagnosis of schizophrenia according to DSM4-TR criteria and clinical interview by psychiatrist, signing written informed consent, a score of at least 60 in PANSS
Exclusion criteria: pregnancy, substance abuse, severe physical disease such as kidney disease, coagulation disorders, GI disorders such as peptic ulcer, contraindications of Aspirin and inhibitors of proton pump
Age
From 15 years old to 55 years old
Gender
Both
Phase
1
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
Arak University Of Medical Sciences,Basij Square,Sardasht,Arak
City
Arak
Postal code
Approval date
2011-07-06, 1390/04/15
Ethics committee reference number
1-110-90
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders.
Primary outcomes
1
Description
PANSS
Timepoint
Before invention and every two weeks
Method of measurement
Clinical examination
Secondary outcomes
1
Description
Extrapyramidal and GI side effect
Timepoint
Before invention and every two weeks
Method of measurement
Clinical examination
Intervention groups
1
Description
Intervention group recieve an atypical antipsychotic plus Aspirin 1000mg/day for 8 weeks
Category
Treatment - Drugs
2
Description
Control group recieve an atypical antipsychotic plus plasebo for 8 weeks
(with the same dose and shape).
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir Hospital
Full name of responsible person
Dr Hamireza 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. Ashtiany
Street address
Basij square,Sardasht,University of medical sciences,Arak
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Hamidreza Jamilian
Position
Board Of Psychiatry
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Sardasht
City
Arak
Postal code
3819691187
Phone
+98 86 1222 5758
Fax
+98 86 1313 2518
Email
Jamilian.Hr@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)