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Comparison of the effects and side effects of the three drugs risperidone, quetiapine and olanzapine in the treatment of psychosis symptoms due to Shisheh

Protocol summary

Study aim
Comparison of the effects of risperidone, quetiapine and olanzapine in the treatment of Shisheh induced psychosis Disorder
Design
The clinical trial has three intervention groups, phase ۳ on 45 patients, a blind strain. Samples are selected by available methods.
Settings and conduct
A study will be conducted on the symptoms of psychosis caused by the use of Shisheh, and the samples will be selected from Razi Hospital in Tabriz and will be divided into three groups: Risperidone, Quetiapine and Elanzapine. Data will be measured once before treatment and after one month with demographic questionnaire, urine test, SCID semi-structured interview, PANSS positive and negative symptom scale, and Glasgow side effect scale. The study is of a blind type and the analysis of the data log will not know which group the sample is in.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from Shisheh induced psychosis Disorder, not suffering from other psychiatric disorders, having informed consent, at least 18 years old Exclusion criteria: Lack of history of mental disorders, epilepsy, brain trauma, unwillingness to continue cooperation, incomplete questionnaires
Intervention groups
Intervention group 1 includes patients with Shisheh induced psychosis Disorder who are treated with risperidone. Intervention group 2 includes patients with Shisheh induced psychosis Disorder who are treated with Quetiapine. Intervention group 3 includes patients with Shisheh induced psychosis Disorder who are treated with Olanzapine.
Main outcome variables
Main outcomes include treatment of psychotic symptoms, positive and negative symptoms associated with Shisheh use

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160530028173N5
Registration date: 2023-12-12, 1402/09/21
Registration timing: registered_while_recruiting

Last update: 2023-12-12, 1402/09/21
Update count: 0
Registration date
2023-12-12, 1402/09/21
Registrant information
Name
Salman Safikhanlou
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3380 4486
Email address
safikhanlous@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-06-20, 1403/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects and side effects of the three drugs risperidone, quetiapine and olanzapine in the treatment of psychosis symptoms due to Shisheh
Public title
Efficacy and side effects of risperidone, quetiapine and olanzapine in the treatment of Shisheh psychosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having criteria for glass-induced psychosis disorder based on DSM-5 (through clinical interview by psychiatrist). Treated with one of the antipsychotics risperidone, quetiapine and olanzapine No other psychiatric disorders Willingness of an individual or family (conscious consent) to participate in the study Minimum age 18 If you have a history of drug treatment for the above disorder, at least three weeks have passed since you stopped taking the drug
Exclusion criteria:
History of mental disorders History of epilepsy History of brain trauma Taking drugs other than target group treatment drugs Unwillingness of the patient or the family to continue cooperating in the study for any reason Incomplete questionnaires If a sample has other psychiatric disorders, including personality disorders, it will be excluded from the plan and will continue its routine treatment. Incidence of drug complications based on the AIMS scale
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
analyst of the data were not aware of which group (risperidone, quetiapine and olanzapine) the sample was. Of course each sample has an special code.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-10-21, 1402/07/29
Ethics committee reference number
IR.TBZMED.REC.1402.535

Health conditions studied

1

Description of health condition studied
psychosis symptoms due to Shisheh
ICD-10 code
f15
ICD-10 code description
Other stimulant related disorders

Primary outcomes

1

Description
Positive Symptoms Severity
Timepoint
Before the intervention, one month after the intervention
Method of measurement
PANSS positive and negative symptom scale

2

Description
Negative Symptoms Severity
Timepoint
Before the intervention, one month after the intervention
Method of measurement
PANSS positive and negative symptom scale

Secondary outcomes

empty

Intervention groups

1

Description
Patients will receive risperidone from Sobhan company daily in the therapeutic range of 2 to 8 mg. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria.
Category
Treatment - Drugs

2

Description
Patients will receive Quetiapine drug of Tadbir Kalai Jam company in the therapeutic range of 25 to 100 mg daily. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria.
Category
Treatment - Drugs

3

Description
Patients will receive Soban's Elanzapine drug in the therapeutic range of 5 to 10 mg daily. The patient will be evaluated by demographic questionnaire, urine test, PANSS positive and negative symptom tools once before starting the treatment and again after one month (according to DSM 5). Patients will be evaluated for drug side effects in the second and fourth weeks using the AIMS scale. In case of drug side effects, the patient will be excluded from the study and will continue the drug treatment process separately. In this regard, the patient's medication will be tapered and discontinued and will be changed to other medications. The substitute person will be entered in place of the exited sample, according to the entry and exit criteria.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Arash Mohagheghi
Street address
Elgoli Road
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
librazi@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Hasan Soleimanpour
Street address
Tabriz University of Medical Sciences, Golgasht Street, Azadi Street
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
salman_safikhanlou@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Arash Mohagheghi
Position
Associate Professor (Psychiatry)
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital, Elgoli Road
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
+98 41 3380 4486
Email
mohaggheghi.a@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Roya Mohammadi
Position
Resident of Psychiatry
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Razi Hospital, elgoli road
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
009833804486
Email
m.royaa1988@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Salman Safikhanlou
Position
Clinical psychologiest
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Razi Hospital, elgoli road
City
Tabriz
Province
East Azarbaijan
Postal code
5167846184
Phone
009833804486
Email
salman_safikhanlou@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
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data including primary outcomes (drug effects and side effects) of participants can be shared after de-identification.
When the data will become available and for how long
The information will be available after analyzing the data and compiling the articles from 2024/09/21.
To whom data/document is available
The data will be accessible to health community researchers.
Under which criteria data/document could be used
The data will be available for research purposes.
From where data/document is obtainable
The data will be available through the study guide Dr. Arash Mohagheghi.
What processes are involved for a request to access data/document
The data will be available by sending a message to Dr. Arash Mohagheghi at the email address mohaggheghi@yahoo.com within one month after sending the email.
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