Study the efficacy of risperidone compared to placebo plus Electroconvulsive therapy in the treatment of persistent psychosis induced by methamphetamine in patients referred to Farabi hospital of Kermanshah
Study the efficacy of risperidone compared to placebo plus Electroconvulsive therapy in the treatment of persistent psychosis induced by methamphetamine in patients referred to Farabi hospital of Kermanshah
Design
This study is a double-blinded clinical trial. The study population will be included all patients who admitted or outpatient with psychosis associated with taking methamphetamine in Farabi hospital of Kermanshah city.12 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study which will be conducted in Farabi hospital of Kermanshah city is double-blinded. At the baseline, the severity of psychosis symptoms will be recorded based on the questionnaire. Then, in the second and fourth weeks, the questionnaire will be returned to the patients and the two groups will be compared in the term of psychosis symptoms severity.
Participants/Inclusion and exclusion criteria
Inclusion criteria: the presence of psychosis due to methamphetamine consumption despite discontinuation of methamphetamine for one month; no history of previous psychiatric disorders such as schizophrenia.
Exclusion criteria: the presence of recent cardiovascular disease based on the patient's history or cardiologist's opinion;
no medical diseases that have psychosis symptoms such as brain tumors and ...; recent cerebrovascular diseases based on the patient's history or neurologists opinion; sensitivity or complications during treatment with risperidone.
Intervention groups
The first intervention group will receive 4 mg Risperidone (in two divided doses) daily for 4 weeks with a two-way frontotemporal ECT.
The second intervention group will receive placebo and ECT as two-way frontotemporal twice a week for 4 weeks (Risperidone and placebo will be provided in 30pcs-drug containers).
Main outcome variables
Severity of psychotic symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N101
Registration date:2018-09-18, 1397/06/27
Registration timing:registered_while_recruiting
Last update:2018-09-18, 1397/06/27
Update count:0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-18, 1397/06/27
Expected recruitment end date
2018-10-19, 1397/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study the efficacy of risperidone compared to placebo plus Electroconvulsive therapy in the treatment of persistent psychosis induced by methamphetamine in patients referred to Farabi hospital of Kermanshah
Public title
Study the efficacy of risperidone in the treatment of persistent psychosis induced by methamphetamine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The presence of psychosis due to methamphetamine consumption despite discontinuation of methamphetamine for one month
No history of previous psychiatric disorders such as schizophrenia and .....
No medical diseases that have psychosis symptoms such as brain tumors and ...
Exclusion criteria:
No persistent psychosis associated with methamphetamine abuse.
The presence of recent cardiovascular disease based on the patient's history or cardiologist's opinion
Sensitivity or side effects during treatment with risperidone. History or presence of primary psychosis
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
Randomly by coin toss
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and researcher will be blinded to the study groups, the dosage of the drug and the manufacturer of the drug
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2017-10-26, 1396/08/04
Ethics committee reference number
IR.KUMS.REC.1396.396
Health conditions studied
1
Description of health condition studied
Amphtamine induced psychotic disorder
ICD-10 code
F 15
ICD-10 code description
Mental and behavioural disorders due to use of other stimulants, including caffeine
Primary outcomes
1
Description
Severity of psychotic symptoms
Timepoint
At the beginning of the study, the second week and at the end of the study (4 weeks after the start of the study)
Method of measurement
Based on the Positive and Negative Symptoms Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive 4 mg Risperidone (in two divided doses) daily for 4 weeks with a two-way frontotemporal ECT.
Category
Treatment - Drugs
2
Description
The second intervention group will receive placebo and ECT as two-way frontotemporal twice a week for 4 weeks (Risperidone and placebo will be provided in 30pcs-drug containers)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Abdoll Reza Darki
Street address
Farabi Hospital, Isar Square, Dolatabad Blvd,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Email
darki121@yahoo.com
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 Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Abdoll Reza Darki
Position
Resident of psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital Isar Square, Dolatabad Blvd,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Email
darki121@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Vahid Farnia
Position
Faculty Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital Isar Square, Dolatabad Blvd,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Email
vahidfarnia@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Abdoll Reza Darki
Position
Resident of psychiatrist
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Farabi Hospital Isar Square, Dolatabad Blvd,
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 1046
Fax
Email
darki121@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
4 months
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 15-day period, the documents will be sent e-mail