Efficacy of risperidone/ NAC versus risperidone on cognitive functioning over the three months of treatment for psychotic disorder: a double-blind randomized clinical trial
Comparison of the effect of acetylcysteine prescriptions in improving the cognitive deficits of schizophrenia with placebo
Design
A randomized clinical trial study will be double-blind, which the patient group covers on the patients themselves, companions, nurses, therapists and psychologists and they are not aware of it.
that the effects of the antipsychotic drug risperidone four milligrams daily along with six hundred milligrams of NAC; (first group)
and antipsychotic drug group risperidone four milligram daily with placebo); (second group)
in the patients included in the study; is compared
. Participants are randomly divided into two groups by block randomization method
The active treatment phase has been three months and the evaluations will be done three and six months later and the results will be compared.
The drugs used by the same pharmaceutical company, and in the case of placebo, are prepared from safe food and are provided to the nurses or the patients' families by the partners of the project in the hospital and at home.
Settings and conduct
Shahid Beheshti Hospital, Zanjan, for three mo.
Participants/Inclusion and exclusion criteria
Filling out the consent form by the patient's guardian and having consent for the patient to enter the research project
Participants had to meet criteria for a DSM-V psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, depression with psychosis, substance-induced psychotic disorder.
The patient is not dangerous and does not pose a danger to herself or others
Intervention groups
In this study, the effects of the drug risperidone along with the antioxidant drug N-acetylcysteine; (first group)
and risperidone with placebo; (control or second group)
in the patients included in the study; It is compared for three months.
Main outcome variables
Positive Symptoms; Negative Symptoms
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240309061224N1
Registration date:2024-04-15, 1403/01/27
Registration timing:registered_while_recruiting
Last update:2024-04-15, 1403/01/27
Update count:0
Registration date
2024-04-15, 1403/01/27
Registrant information
Name
nasrin pilafkan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3347 8915
Email address
drsseyedi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-07, 1403/01/19
Expected recruitment end date
2024-09-09, 1403/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of risperidone/ NAC versus risperidone on cognitive functioning over the three months of treatment for psychotic disorder: a double-blind randomized clinical trial
Public title
The effect of NAC in psychotic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Filling out the consent form by the patient's guardian and having consent for the patient to enter the research project
Being in the category of psychotic diseases : Participants had to meet criteria for a DSM-V psychotic disorder, including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, depression with psychosis, substance-induced psychotic disorder.
The patient is not dangerous and does not pose a danger to herself or others
Exclusion criteria:
Dissatisfaction : Lack of consent, not filling out the consent form by the patient's guardian and not having consent for the patient to enter the research project
Being dangerous to yourself or others: The dangerousness of the patient and the high probability of having a risk of life and injury to oneself and others
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are randomly assigned to one of the two categories in the order of arrival and admission to the hospital. The block randomization method is used to allocate the samples to each of the groups. For this purpose, blocks of 6 will be used, and the site sealedenvelope.com will be used to synthesize the blocks.
Due to the blinding done, the possibility of identifying the assigned group is prevented
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients, doctors and nurses not knowing about the patient group and distribution of drugs by a person who has no role in treatment and data analysis
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences؛ Gavazang ؛ ZanjanBlvd ؛
City
Zanjan
Province
Zanjan
Postal code
4537138791
Approval date
2024-02-02, 1402/11/13
Ethics committee reference number
IR.ZUMS.REC.1402.257
Health conditions studied
1
Description of health condition studied
The schizophrenic disorders
ICD-10 code
F20
ICD-10 code description
The schizophrenic disorders are characterized in general by fundamental and characteristic distortions of thinking and perception, and affects that are inappropriate or blunted
2
Description of health condition studied
Delusional disorders
ICD-10 code
F22
ICD-10 code description
Delusional disorders is a medical classification as listed by WHO under the range - Mental, Behavioral and Neurodevelopmental disorders
3
Description of health condition studied
Schizoaffective disorders
ICD-10 code
F25
ICD-10 code description
Schizoaffective disorders is a medical classification as listed by WHO under the range - Mental, Behavioral and Neurodevelopmental disorders
4
Description of health condition studied
Mental and behavioural disorders
ICD-10 code
F19.5
ICD-10 code description
Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances Psychotic disorder
Primary outcomes
1
Description
Positive and negative symptoms
Timepoint
(0) On arrival - 3 and 6 months after the intervention
Method of measurement
Interviews and psychological tests
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: give NAC. The antipsychotic drug risperidone four milligrams daily along with six hundred milligrams of the antioxidant N-acetylcysteinePreparation of the drug from reputable domestic pharmaceutical companies
Category
Treatment - Drugs
2
Description
Control group: Placebo..The antipsychotic drug Risperidone four milligram per day along with placebo is prepared from reputable domestic companies and is completely safe for patients.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Zanjan
Full name of responsible person
Pilafkan Nasrin MD
Street address
Shahid Beheshti Hos., North Sadi Blv., Ark Sq., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 2403
Email
drsseyedi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mostafavi Hosein MD
Street address
Vice President of Research, Zanjan University of Medical Sciences- Azadi Blv.
City
Zanjan
Province
Zanjan
Postal code
4515613191
Phone
+98 912 740 9298
Fax
+98 24 3342 4770
Email
research@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
ZUMS
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Pilafkan Nasrin MD
Position
Psychiatry Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hos., North Sadi Blv., Ark Sq., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 2403
Email
drsseyedi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Armani Kian Alireza MD
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hos., North Sadi Blv., Ark Sq., Zanjan
City
zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 2403
Email
Dr.armani@zums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Pilafkan Nasrin MD
Position
psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Shahid Beheshti Hos., North Sadi Blv., Ark Sq., Zanjan
City
Zanjan
Province
Zanjan
Postal code
4513615788
Phone
+98 24 3354 2403
Email
drsseyedi@gmail.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
By Article
When the data will become available and for how long
about 1 year
To whom data/document is available
everyone esp. Psychiatrists
Under which criteria data/document could be used
Use to treat or improve the condition of patients
From where data/document is obtainable
Shahid Beheshti Hos- pilafkan Nasrin MD
What processes are involved for a request to access data/document