In the present study, the effect of adding Simvastatin to Atypical antipsychotics in reducing negative symptoms of schizophrenia patients is desired. This study is a randomized, double-blind, Placebo-controlled, single-center, the two trials is the inclusion criteria include: (1) Schizophrenia, (2) negative score over 15 in PANSS Exclusion criteria: (1) Cancel the patients participating in the study, (2) The adverse drug reactions of patients is 30. Patients during the 6-week study by the PANSS Scale (Positive & Negative Symptom Scale) were evaluated weekly and efficacy of Simvastatin and Placebo on social withdrawal, emotional withdrawal, blunted affect and other negative symptoms were evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017052034046N1
Registration date:2017-06-17, 1396/03/27
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-17, 1396/03/27
Registrant information
Name
Somayeh Ashrafi
Name of organization / entity
Ahwaz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 3445 6807
Email address
ashrafi.so@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Ahwaz University of Medical Sciences, Doctor Behzad Sharif Makhmal Zadeh
Expected recruitment start date
2012-06-21, 1391/04/01
Expected recruitment end date
2013-01-19, 1391/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Determine the effect of Simvastatin to control negative symptoms of atypical antipsychotics in patients with schizophrenia
Public title
Effect of Simvastatin in the treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria for this study: having a diagnosis of schizophrenia according to DSM-IV-TR؛ a PANSS total score of 50 or higher on the scale؛ the scale PANSS negative score of 15 or more of 70-18 years, during a period of at least 1 year of disease onset.
Exclusion criteria for this study: patients with a history of sensitivity to statins ؛ active liver disease or increase stability and unexplained liver enzymes؛ kidney failure؛ medical condition serious؛ drug abuse or drug dependence during the previous month؛ pregnancy؛ lactation؛ there at the same time other psychiatric disorders requiring drug therapy؛ desire to commit suicide or homicide؛ possession of dementia and cognitive impairment serious؛ unrelated to schizophrenia؛ organic disease of the brain such as seizures and severe mental retardation and Parkinson's disease, Taking anti psychotic oral over the past month or long-acting injections over the past three months؛ the concomitant use of other drugs such as antidepressants or lithium؛ etc. which may be a result of treatment interfere؛ schizophrenia resistant to treatment؛ lack of response to an adequate dose and appropriate for typical anti psychotic drugs.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
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
Department of Development Research Ethics Committee of the Ahwaz University of Medical Sciences
Street address
Ahvaz University of Medical Sciences, City University, Golestan
City
Ahwaz
Postal code
Approval date
2012-05-12, 1391/02/23
Ethics committee reference number
ETH - 457
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia are generally identified by distorting the basic characteristics of thinking and perception, and affects that are inappropriate or not. Clear consciousness and intellectual capacity are usually maintained although certain cognitive deficits
Primary outcomes
1
Description
Emotional withdrawal
Timepoint
Before the studyꓼ week thirdꓼ sixth week
Method of measurement
PANSS (Positive and Negative Symptom Scale)
Secondary outcomes
1
Description
Social withdrawal
Timepoint
Before the experiment three weeks after the interventionꓼ six weeks after intervention
Method of measurement
PANSS (Positive And Negative Symptom Scale)
Intervention groups
1
Description
In the intervention group: Simvastatin Tablets, 20 mg orally, once a day for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: Placebo tablet, 20 mg oral, once a day for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Psychiatry
Full name of responsible person
Somayeh Ashrafi
Street address
Golestan, City University, Ahvaz University of Medical Sciences, Psychiatric ward
City
Ahwaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Ahwaz University of Medical Sciences
Full name of responsible person
Doctor Behzad Sharif Makhmal Zadeh
Street address
Ground Floor, Vice Chancellor for Research and Technology Development, Ahvaz University of Medical Sciences, City University, Golestan
City
Ahwaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Ahwaz 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
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Doctor Seyed Mohammad Seyed Ghaffari Dezffooli
Position
Department of Psychology / Psychiatrist
Other areas of specialty/work
Street address
Ahvaz University of Medical Sciences, City University, Golestan
City
Ahwaz
Postal code
Phone
+98 61 3336 7543
Fax
Email
ashrafi.so@ajums.ac.ir
Web page address
www.ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Somayeh Ashrafi
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
Ahvaz University of Medical Sciences, City University, Golestan
City
Ahwaz
Postal code
6481958956
Phone
+98 61 3336 7543
Fax
Email
ashrafi.so@ajums.ac.ir ; dr.ashrafi77@gmail.com
Web page address
www.ajums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ahwaz Jundishapur University of Medical Sciences
Full name of responsible person
Doctor Seyed Mohammad Seyed Ghaffari Dezfooli
Position
Assistant Professor of Psychiatry /Psychiatrist
Other areas of specialty/work
Street address
Ahvaz University of Medical Sciences, City University, Golestan
City
Ahwaz
Postal code
6481958956
Phone
+98 61 3336 7543
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)