Comparison of COMT Gene Polymorphisms and Response to Treatment and incidence of Extrapyramidal Side Effects in Schizophrenic Patients Treated with Olanzapine and Risperidone
In this study we have evaluated the effect of the COMT gene polymorphism RS4680 comparing Olanzapine and Risperidone drug groups on the response to treatment and the incidence of extra pyramidal side effects (EPS) and other anti psychotic side effects. In this study, 61 patients with demonstrated schizophrenia in two Olanzapine and Risperidone treated groups were matched for different characteristics and we were monitored for eight weeks of the study. Inclusion criteria: schizophrenia with PANSS score more than 60; don’t use anti psychotic drug one week before; IQ more than 70; don’t use anti psychotic drug in 6 months ago; don’t use Electrocardiography Therapy in one month ago.Exclusion criteria: psychiatric disorders in axis 1 and 2; Suicide and other plumbing; addiction in 6 months ago; severe drug side effects Response to treatment and extra pyramidal side effects was evaluated by PANSS and ESRS-Aforms respectively. A list containing common multiple drugs side effects were used to assess some common complications.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017012520258N29
Registration date:2017-02-10, 1395/11/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-10, 1395/11/22
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor Research ,Arak University of Medical Sciences
Expected recruitment start date
2014-05-06, 1393/02/16
Expected recruitment end date
2015-05-06, 1394/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of COMT Gene Polymorphisms and Response to Treatment and incidence of Extrapyramidal Side Effects in Schizophrenic Patients Treated with Olanzapine and Risperidone
Public title
Effect of gen for Schizophrenic Patients Treated with drug
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: schizophrenia with PANSS score more than 60; don’t use anti psychotic drug one week before; IQ more than 70; don’t use anti psychotic drug in 6 months ago; don’t use Electrocardiography Therapy in one month ago
Exclusion criteria: psychiatric disorders in axis 1 and 2; Suicide and other plumbing; addiction in 6 months ago; severe drug side effects
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
61
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Dr Mohammad Rafiei, Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Postal code
38149578558
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
93-162-13
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F06.2
ICD-10 code description
Organic delusional [schizophrenia-like] disorder
Primary outcomes
1
Description
Response to treatment
Timepoint
after 8 week treatment
Method of measurement
PANSS form
2
Description
extra pyramidal side effects
Timepoint
after 8 week treatment
Method of measurement
ESRS-A form
3
Description
drugs side effects
Timepoint
after 8 week treatment
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: We prescribe 2-12 milligram Risperidone daily.
Category
Treatment - Drugs
2
Description
Intervention group: We prescribe 5-25 milligram Olanzapine daily.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amirkabir hospital
Full name of responsible person
Dr Bahman Salehi
Street address
Amirkabir hospital, Parastar Square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Arak University of Medical Sciences