The objective of this randomized, double-blind, placebo controlled study is to test the hypothesis that the addition of Simvastatin would improve psychopathology in subjects with schizophrenia treated with Risperidone. 50 patients with chronic DSM-5-diagnosed schizophrenia will receive Risperidone (4-6 mg/day) combined with either placebo (N=25) or 40 mg/day of Simvastatin (N=25) for 8 weeks. Efficacy will be defined as the change from baseline to endpoint in score on the Positive and Negative Syndrome Scale (PANSS). Side effects will be also evaluated using checklist and Extra-pyramidal Symptoms Rating Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201410021556N65
Registration date:2014-10-28, 1393/08/06
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-10-28, 1393/08/06
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Simvastatine in the treatment of negetive symptoms in stable schizophrenia: a double blind and randomised clinical trial
Public title
Simvastatine in the treatment of schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:1-Diagnosis of Schizophrenia based on DSM- 5 criteria;2- Minimum Score of 20 in negative subscale of Positive and Negative Scale(PANNS) 3- Age between 18-50; 4- chronic Schizophrenia- duration of the disorder more than 2 years; ;
Exclusion Criteria:1-any other mental disorder on axis I; 2-Any serious medical or neurological problem; 3- IQ less than 70; 4- Substance dependence(except for nicotine and caffeine); 5-receiving ECT during the last 14 days,6-Depression Score less than 12 in Hamilton depression scale
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Ethics Committee of Tehran University of Medical Sciences
Street address
Keshvarz Blvd
City
Tehran
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
26261
Health conditions studied
1
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
schizophrenia
Primary outcomes
1
Description
Severity of schizophrenia
Timepoint
Baseline and weeks 2-4-8 after beginig of treatment
Method of measurement
Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
1
Description
extrapyramidal side effects
Timepoint
Baseline and weeks 2-4-6-8 after beginig of treatment
Method of measurement
by Extrapyramidal Symptoms Rating Scale
Intervention groups
1
Description
Tablets Risperidone (4-6 mg/day) combined with 40 mg/day simvastatin as intervention group for 8 weeks
Category
Treatment - Drugs
2
Description
Tablet Risperidone (4-6 mg/day) combined with placebo as control group for 8 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh Hospital
Full name of responsible person
Prof. Shahin Akhondzadeh
Street address
South Kregar street, Roozbeh Hospital
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr masoud yunesian
Street address
Keshvarz Blvd
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?