According to DSM-IV-TR, Amphetamine induced psychotic disorder occurs within one month after amphetamine withdrawal or intoxication. This disorder is common in amphetamine users and needs to be treated because of severity of symptoms. There is no standard guideline for treatment of this disorder. Risperidone is an atypical antipsychotic which is effective in acute psychosis and has fewer side effects compared to typical antipsychotics. Aripiprazole is a partial D2, 5-HT1A agonist which is effective in acute psychosis and has fewer side effects compared to typical and atypical antipsychotics. We conducted a clinical trial to compare efficacy of Rsperidone and Aripiprazole for treatment of this disorder. This is a randomized clinical trial. 38 patients which refereed to Kermanshah University of Medical Sciences will be studied in two groups after clinical interview according to our inclusion and exclusion criteria. Patients in group 1 and 2 receive 4 mg Rsperidone and 15mg Aripiprazole for 6 weeks respectively. Patients will be assessed by Positive and Negative Syndrome Scale Questionnaire before and after treatment course.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201205029620N1
Registration date:2012-08-21, 1391/05/31
Registration timing:na
Last update:
Update count:0
Registration date
2012-08-21, 1391/05/31
Registrant information
Name
Vahid Farnia
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 0700
Email address
vfarnia@kums.ac.ir
Recruitment status
Not enough for processing
Funding source
Vice-chancellor for research, Kermanshah university of medical sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Risperidone vs Aripiprazole in amphetamine induced psychotic disorder
Public title
Comparison of Risperidone vs Aripiprazole in amphetamine induced psychotic disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1- diagnosis of amphetamine induced psychotic Disorder; 2- Patients agreement for treatment. Exclusion criteria: 1- any history of previous medical & psychiatric disorders; 2- any medication which currently is used; 3- any substance which currently is used.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
kermanshah university of medical sciences
Street address
vice-chancellor for research, kermanshah university of medical sciences
City
kermanshah
Postal code
Approval date
2012-01-31, 1390/11/11
Ethics committee reference number
61021/420/7/پ
Health conditions studied
1
Description of health condition studied
amphtamine induced psychotic disorder
ICD-10 code
F 15 .15
ICD-10 code description
F 15 .150 - F 15 .151 - F 15 .159
Primary outcomes
1
Description
Severity of psychotic symptoms
Timepoint
6 Weeks after begining of treatment course
Method of measurement
PANSS Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Risperidone 4 mg daily
Category
Treatment - Drugs
2
Description
aripiprazole 15mg/daily
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi educational and treatment center
Full name of responsible person
Vahid Farnia
Street address
Farabi hospital- Isar Blvd
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
Vice-chancellor for research - Kermanshah university of medical sciences
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
Vahid Farnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Farabi hospital- Isar Blvd
City
Kermanshah
Postal code
Phone
+98 83 1826 0700
Fax
Email
vfarnia@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical sciences
Full name of responsible person
Vahid Farnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Farabi hospital- Isar Blvd
City
Kermanshah
Postal code
Phone
+98 83 1826 0700
Fax
Email
vfarnia@kums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)