Schizophrenia is a major disabilitating psychiatric disorder which is continually under investigation to reduce its destructive effects. Recently it has been suggested that naltrexone (an opioid antagonist) can be used for treatment of negative and positive symptoms of schizophrenia. This research has been designed to evaluate the efficacy of naltrexone in the negative and positive symptoms of the disorder. This is a double blind study. 30 patients with schizophrenia will be chosen in a random manner whom will be divided into two equal groups. In one group naltrexone will be added to the therapeutic regimen, while the other group will receive placebo instead of naltrexone. Inclusion criteria: all schizophrenic patients hospitalized in Farabi Hospital. Exclusion criteria: 1) Any patients who refuse to participate in the study. 2) any sensitivity to naltrexone. The PANSS questionnaire, Anderson test for positive and negative symptoms of schizophrenia, will be used in the beginning and at the end of the study. Naltrexone should be administered for 12 weeks and in a 100 mg/d dosage.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201110093010N4
Registration date:2012-12-07, 1391/09/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-12-07, 1391/09/17
Registrant information
Name
Faeze Tatari
Name of organization / entity
Kermanshah University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 83 1427 4618
Email address
ftatari@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2012-12-21, 1391/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the efficacy of naltrexone on positive and negative symptoms in schizophrenic patients
Public title
Study of the efficacy of naltrexone on positive and negative symptoms in schizophrenic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: all schizophrenic patients hospitalized in Farabi Hospital. Exclusion criteria: 1) Any patients who refuse to participate in the study. 2) Any sensitivity to naltrexone.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Kermanshah University of Medical Scienses
Street address
Bilding 2., Kermanshah University of Medical Scienses, Shahi Beheshti blvd.
City
Kermanshah
Postal code
Approval date
2012-09-22, 1391/07/01
Ethics committee reference number
٧/٤٢٠/٣٢٦٣٨/پ
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Positive and negative symptoms
Timepoint
Before the intervention and after 12 weeks
Method of measurement
PaNSS (Anderson test) scores
Secondary outcomes
empty
Intervention groups
1
Description
Placebo in cap form. 2 cap bid
Category
Placebo
2
Description
Naltrexone cap. 2 cap bid.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kermanshah Farabi Hospital
Full name of responsible person
Dr Faezeh Tatari
Street address
Ashayer sq.
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Bilding 2, Kermanshah University of Medical Sciences , Shahid Beheshti blvd.
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Faezeh Tatari
Position
Psychiatrist/assisstant professor
Other areas of specialty/work
Street address
Ashayer sq.
City
Kermanshah
Postal code
Phone
+98 83 1836 3319
Fax
+98 83 1724 5640
Email
ftatari@kums.ac.ir ; fztatari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Faezeh Tatari
Position
Psychiatrist, assisstant professor
Other areas of specialty/work
Street address
Ashayer sq.
City
Kermanshah
Postal code
Phone
+98 83 1836 3319
Fax
+98 83 1724 5640
Email
ftatari@kums.ac.ir ; fztatari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr Faezeh Tatari
Position
Psychiatrist/assisstant professor
Other areas of specialty/work
Street address
Ashayer sq.
City
Kermanshah
Postal code
Phone
+98 83 1836 3319
Fax
+98 83 1724 5640
Email
ftatari@kums.ac.ir ; fztatari@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)