(1) Objectives: our aim in this study is to evaluate the effects of Risperidone on reducing the symptoms of methamphetamine induced psychosis.
(2) Design: In an intervention study with before and after design, 32 patients with methamphetamine induced psychosis from both genders will be selected from addiction treatment ward after qualifying the inclusion and exclusion criteria and obtaining the informed consent.
(3) Setting and conduct: After a positive urine amphetamine test and diagnosis of psychotic disorder due to methamphetamine use which is going to be confirmed by a psychiatrist, SANS (for negative symptoms) and SAPS (for positive symptoms) scales will be performed. Risperidone will be administered based on therapeutic dose after scoring and determining the severity of symptoms. After one week, SANS and SAPS scales are going to be performed again and results will be compared.
Exclusion criteria will be patient's unwillingness to continue to participate in the study.
(4)Interventions: after clinical interview and scaling of SANS and SAPS , Risperidone will be administered by the severity of symptoms.
(5)Main outcome measures: SAPS scale for measuring positive symptoms of psychosis and SANS scale for measuring negative symptoms of psychosis, then these scales will be compared one week after administration of Risperidone.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311199858N5
Registration date:2013-11-30, 1392/09/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-11-30, 1392/09/09
Registrant information
Name
Arash Mohagheghi
Name of organization / entity
Clinical Psychiatry Research Center
Country
Iran (Islamic Republic of)
Phone
+98 3353098411380
Email address
mohagheghia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2013-12-01, 1392/09/10
Expected recruitment end date
2014-05-31, 1393/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Risperidone on reducing the symptoms of methamphetamine induced psychosis
Public title
Effect of Risperidone on psychosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. At least 18 years of age
2. Diagnosis of methamphetamine induced psychosis with structured clinical interview SCID by the approval of a psychiatrist or a psychologist.
3. No anti-psychotic drug use.
4. No other psychological disorders.
Exclusion criteria:
Patient's unwillingness to continue to participate in the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for Research, Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research, tabriz University of Medical Sciences, Daneshgah street, tabriz
City
Tabriz
Postal code
Approval date
2013-11-18, 1392/08/27
Ethics committee reference number
5/4/6905
Health conditions studied
1
Description of health condition studied
سایکوز ناشی از مصرف مواد
ICD-10 code
F15.5
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine
Primary outcomes
1
Description
Negative symptoms of psychosis
Timepoint
before intervention and 1 week after intervention
Method of measurement
Scale for the Assessment of negative Symptoms (SANS)
2
Description
Positive symptoms of psychosis
Timepoint
before intervention and 1 week after intervention
Method of measurement
Scale for the Assessment of Positive Symptoms (SAPS)
Secondary outcomes
empty
Intervention groups
1
Description
After determining the severity of symptoms and scoring by the physician, Tablet Risperidone 1 mg daily with therapeutic dosage of 1 to 3 mg daily will be administered for 1 week.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr. Arash Mohagheghi
Street address
Razi Hospital, El Goli Road, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tabriz 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
Clinical Psychiatry Research Center
Full name of responsible person
Dr. Arash Mohagheghi
Position
Associate professor of psychiatry
Other areas of specialty/work
Street address
Clinical Psychiatry Research Center, Razi Hospital, El Goli Road, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
mohaggheghi.a@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Clinical Psychiatry Research Center
Full name of responsible person
Dr. Arash Mohagheghi
Position
Associate professor of psychiatry
Other areas of specialty/work
Street address
Clinical Psychiatry Research Center, Razi Hospital, El Goli Road, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
mohaggheghi.a@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Clinical Psychiatry Research Center
Full name of responsible person
Dr. Arash Mohagheghi
Position
Associate professor of psychiatry
Other areas of specialty/work
Street address
Clinical Psychiatry Research Center, Razi Hospital, El Goli Road, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1380 3353
Fax
Email
mohaggheghi.a@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)