NSAID drugs inhibit prostaglandin synthesis by inactivation of cyclooxygenaze and are effective in this way. Inhibitors of non-selective COX such as aspirin, with protective effect on the heart are preferred. Also non-selective COX inhibitor range effects are higher due to inhibition of both enzymes COX1 and COX2. 4O patients admitted to Ibn Sina hospital of Mashhad are included in this research. Baseline includes demographic data for patients, the PANSS test to assess psychological symptoms, wechser, Wisconsin, stroop, BPRS and digit span tests to assess cognitive status. Evaluations are made as a double-blind in two groups to control the symptoms of psychosis under treatment with rispridone . Dose of rispridone started with 2mg and within a week titrated to 6mg or maximum dose tolerated by the patient. Patients were randomly divided into two groups and the treatment of the first group starts with 1000mg aspirin (500mg aspirin daily, Abidi company) and the placebo group with 2 tablets resembling 500mg aspirin daily. Clinical and cognitive evaluations are repeated at weeks 3, 6 and 12. In each patient, the drug complication will be examined.
Patients entered into research:
- diagnosis of schizophrenia based on DSM-IV
- PANSS score at the beginning of the project is more than 60.
-Between 3-1 episodes or less than 5 years of disease duration.
Exclusion criteria: - Need to be using other drugs. (Anticholinergics and benzodiazepines are except)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201109287660N1
Registration date:2012-11-08, 1391/08/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-11-08, 1391/08/18
Registrant information
Name
Maryam Tavakoli
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1761 1849
Email address
tavakolim881@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2012-04-03, 1391/01/15
Expected recruitment end date
2012-11-05, 1391/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aspirin augmentation on cognitive & clinical symptoms of schizophrenic patients
Public title
Effect of Aspirin in schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1 - Is based on DSM-IV diagnosis of schizophrenia. 2 - The patient or patient's guardian consent to participate. 3 - PANSS score at the beginning of the project is more than 60. 4 - less than 5 years of disease duration and between 3 to 1 episodes. 5 - No physical disease based on clinical examination. 6 - Chronic NSAID is not used. 7 - Not taking corticosteroids. 8 - Not pregnant. 9 - there is no contraindication for aspirin and omeprazole. Exclusion criteria: 1 - Sensitivity to the drug 2 - Patients who choose to be excluded. 3 – Require other drugs. (Anticholinergics and benzodiazepines are excepted) 4 – Where ECT is needed.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Mashhad University of Medical Sciences
Street address
Ghoreishi Building ,Daneshgah Street
City
Mashhad
Postal code
Approval date
2011-09-18, 1390/06/27
Ethics committee reference number
89921
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20.0
ICD-10 code description
Paranoid schizophrenia
Primary outcomes
1
Description
cognitive disorders
Timepoint
baseline and 3th,6th,12th weeks
Method of measurement
cognition tests
2
Description
clinical symptoms
Timepoint
baseline and 3th,6th,12th weeks
Method of measurement
PANSS
Secondary outcomes
empty
Intervention groups
1
Description
Case group:Tab Aspirin 500 mg ,BID( Abidi company)
Category
Placebo
2
Description
placebo group: tab placebo Aspirin like 500 mg ,BID
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Psychitric Ibne_Sina Hospital
Full name of responsible person
Dr. Maryam Tavakoli
Street address
Ferdosi Sq, Hore Ameli Blvd
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Miss Ardekanian
Street address
Ghoreishi Building, Daneshgah Street
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Psychiatric Ibnesina Hospital
Full name of responsible person
Dr. Maryam Tavakoli
Position
Psychiatric resident
Other areas of specialty/work
Street address
Hore Ameli Blvd, Ferdosi Sq.
City
Mashhad
Postal code
Phone
+98 51 1761 1849
Fax
Email
tavakolim881@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Psychiatric Ibnesina Hospital
Full name of responsible person
Dr. Maryam Tavakoli
Position
Psychiatric resident
Other areas of specialty/work
Street address
Hore Ameli Blvd, Ferdosi Sq.
City
Mashhad
Postal code
Phone
+98 51 1761 1849
Fax
Email
tavakolim881@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Psychiatric Ibnesina Hospital
Full name of responsible person
Dr. Maryam Tavakoli
Position
Psychiatric resident
Other areas of specialty/work
Street address
Hore Ameli Blvd, Ferdosi Sq.
City
Mashhad
Postal code
Phone
+98 51 1761 1849
Fax
Email
tavakolim881@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)