This study is a randomized double-blind clinical trial which is performed on patients with schizophrenia diagnosis admitted in Goolestan hospital psychiatric ward. 40 male and female patients, who are diagnosed as schizophrenics during interviews done by at least two psychiatrists according to DSM-IV TR and have inclusion criteria, will be divided randomly to intervention and control groups (Atorvastatin plus Risperidone and placebo plus Risperidone). Researcher and person who evaluates will be unaware of this choice. In both groups, 2 mg of Risperidone per day will be started and will be increased to 6 mg per day if it is necessary. In intervention group, Atorvastatin at a dose of 20 mg per day and in control group placebo prepared like Atorvastatin will be added to Risperidone. These two groups will receive placebo or drug for 6 weeks, Biperiden up to 6 mg per day will be permitted if motor complications occur or if it is necessary. Patients can receive up to 2 mg Clonazepam per day. All patients will be checked at the start and weeks 1, 3, 4 and 6 with PANSS criteria to evaluate negative symptoms of schizophrenia and two groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202067290N1
Registration date:2012-03-22, 1391/01/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-22, 1391/01/03
Registrant information
Name
Mehdi Sayyah Bargard
Name of organization / entity
Jundishapur University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1336 7571
Email address
sayah_bargard@hotmail.com
Recruitment status
Recruitment complete
Funding source
Jundishapur university of medical sciences
Expected recruitment start date
2011-11-22, 1390/09/01
Expected recruitment end date
2012-07-22, 1391/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of atorvastatine -as an adjuant- in reduction of negative symptoms in schizophrenic inpatients
Public title
Evaluation of atorvastatine effect in reduction of negative symptoms in inpatients with schizophrenia disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: a diagnosis of schizophrenia according to DSM-IV-TR; an overall score of 50 or higher on the PANSS scale; 15 or higher negative score in PANSS scale; age range between 70-18 years; duration of at least 1 year from onset of the illness. Exclusion criteria: history of sensitivity to statins; active liver disease or inexcusable stable increase in liver enzymes ; renal failure; serious medical illness; substance abuse or dependency in recent months; pregnancy; lactation; other simultaneous psychiatric disorders requiring medication; desire to homicide or suicide; having dementia and severe cognitive impairments not bound to schizophrenia; organic brain disorders such as seizure; severe mental retardation and Parkinsonism; consumption of oral antipsychotics during last month or long-acting Injectable forms within three months; Concomitant use of other drugs such as antidepressants; lithium which may interfere in treatment; drug-resistant schizophrenia disorder;, lack of response to appropriate dosage and duration of Risperidone.
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
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
Jundishapur university of medical sciences
Street address
Vice chancellor for research, Jundishapur university of medical sciences