Comparison of aspirin and simvastatin efficacy as adjuvant treatment on negative and positive symptoms and general psychopathology in patient with schizophrenia
Determining the effectiveness of aspirin and simvastatin as adjunctive therapy in hospitalized patients with schizophrenia and using treatment with greater effectiveness and fewer complications in these patients
Design
In this study, three intervention groups will be considered and patients will be randomly divided between these three groups. The design of this study in terms of blinding will be double-blind.
Settings and conduct
This study will be performed in the period of May 2021 to December 2021 in the men and women wards of Razi Psychiatric Hospital. Razi Psychiatric Hospital is one of the centers covered by the University of Social Welfare and Rehabilitation Sciences.
Participants/Inclusion and exclusion criteria
Male and female patients with schizophrenia from the age group of 18 to 60 years whose disease duration is more than 2 years and have no substance dependence or underlying disease.
Intervention groups
Individuals included in the study will be randomly divided between intervention and control groups. Groups A and B are known as the intervention group and group C as the control group.
All three groups will first be treated with risperidone tablets 4-6 mg daily for 2 weeks, then group A will receive 625 mg of aspirin daily (two capsules containing 325 mg of aspirin powder prepared under the supervision of a pharmacist) and group B will receive treatment. 40 mg of simvastatin daily (two capsules containing 20 mg of simvastatin powder prepared under the supervision of a pharmacist) is added to the treatment and in the control group, placebo capsules will be used.
Main outcome variables
Adjuvant treatment of patients with schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210110049994N1
Registration date:2021-02-05, 1399/11/17
Registration timing:prospective
Last update:2021-02-05, 1399/11/17
Update count:0
Registration date
2021-02-05, 1399/11/17
Registrant information
Name
Matina Pourghasem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6691 8929
Email address
matinapourghasem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-05, 1400/02/15
Expected recruitment end date
2021-12-06, 1400/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of aspirin and simvastatin efficacy as adjuvant treatment on negative and positive symptoms and general psychopathology in patient with schizophrenia
Public title
Effect of aspirin and simvastatin in schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalized patients with schizophrenia who have been diagnosed for more than 2 years
Exclusion criteria:
Patients with schizophrenia with a history of physical illness such as gastrointestinal disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
In order to eliminate some possible biases in this study, randomization will be observed. In this study, a random sequence of numbers will be created using the web-based software https://www.Randomization.com to randomly assign individuals to three groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The packaging and drug form of the capsules and placebo was similar to each other to preserve the blindness of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation
Street address
No.6 . Samani Alley. Forsat Shirazi Ave
City
Tehran
Province
Tehran
Postal code
1419913661
Approval date
2019-11-01, 1398/08/10
Ethics committee reference number
IR.USWR.REC.1398.130
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Comparison of aspirin and simvastatin efficacy as adjuvant treatment on negative and positive symptoms and general psychopathology in patient with schizophrenia
Timepoint
The beginning of the study، 4 and 8 weeks after taking aspirin or simvastatin
Method of measurement
Positive and Negative Symptoms Scale for Schizophrenia
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients with schizophrenia that were treated by risperidone to whom 650 mg of aspirin (325 mg twice daily) will be added daily.
Category
Treatment - Drugs
2
Description
Intervention group: patients with schizophrenia that were treated by risperidone to whom 40 mg of simvastatin (20mg twice daily) will be added daily.
Category
Treatment - Drugs
3
Description
Control group: patients with schizophrenia that were treated by risperidone who will be given placebo.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi psychiatric hospital
Full name of responsible person
Matina Pourghasem
Street address
No.6, Samani Alley, Forsat Shirazi Ave
City
Tehran
Province
Tehran
Postal code
1419913661
Phone
+98 21 6691 8929
Email
matinapourghasem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khorram khorshid
Street address
Koodakyar Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2832 2822
Email
rd@uswr.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Matina Pourghasem
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No.6, Samani Alley, Forsat Shirazi Ave
City
Tehran
Province
Tehran
Postal code
1419913661
Phone
+98 21 6691 8929
Fax
Email
matinapourghasem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Gita Sadighi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Koodakyar Ave, Daneshjoo Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 21 2218 0083
Email
g_sadighi_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Matina Pourghasem
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
No.6, Samani Alley, Forsat Shirazi Ave
City
Tehran
Province
Tehran
Postal code
1419913661
Phone
+98 21 6691 8929
Fax
Email
matinapourghasem@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available