Studying the effect of Adalimumab in the treatment of patients with chronic schizophrenia: A randomized double blind and placebo controlled clinical trial
Studying the effect of Adalimumab in the treatment of patients with chronic schizophrenia
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be performed on patients with chronic schizophrenia attending Roozbeh Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of positive and negative symptoms based on DSM-5; attending hospital with a psychosis attack; age between 18 to 60 years old. Exclusion criteria: head trauma; history of shock therapy during past three months prior to the trial; undergoing neurosurgery; presence of acute or chronic systemic diseases; history of allergy to the medication used in this research; receiving any anti-psychotic medications during past eight weeks prior to the trial.
Intervention groups
Patients with chronic schizophrenia (based on DSM-5 diagnostic criteria) are included in the study and divided into two control (25 participants) and intervention (25 participants) groups. Participants in the intervention group receive Adalimumab subcutaneous injection (40 mg) by pen-injector at weeks 0 and 4, and participants in the control group receive placebo at weeks 0 and 4. Using Positive and Negative Symptoms Scale (PANSS), patients' positive and negative symptoms are assessed at weeks 0, 4 and 8. The side effects of Adalimumab will also be evaluated and compared. Also, at weeks 0 and 8 of the study, blood samples will be taken from patients and IFN-γ, IL-1β, IL-6, IL-8 levels will be measured and compared in two groups.
Main outcome variables
Severity of schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N126
Registration date:2020-05-17, 1399/02/28
Registration timing:prospective
Last update:2020-05-17, 1399/02/28
Update count:0
Registration date
2020-05-17, 1399/02/28
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2022-06-22, 1401/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of Adalimumab in the treatment of patients with chronic schizophrenia: A randomized double blind and placebo controlled clinical trial
Public title
The effect of Adalimumab in the treatment of patients with chronic schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of positive and negative symptoms based on DSM-5
Attending hospital with a psychosis attack
Age between 18 to 60 years old
Exclusion criteria:
Head trauma
History of shock therapy during past three months prior to the trial
Undergoing neurosurgery
Presence of acute or chronic systemic diseases
History of allergy to the medication used in this research
Receiving any anti-psychotic medications during past eight weeks prior to the trial
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization: using A and B blocks with n=4; AABB, ABAB, ABBA, BABA, BAAB, BBAA. We randomly use the blocks to achieve total sample size. ("A" and "B" are the study groups)
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, care providers and outcome assessors will be blind regarding grouping. All the participants believe that they are taking the main medication (the participants who are taking placebo are not aware of it). Care providers and outcome assessors do not know which participants have received the main medication and which participants have received placebo. Thus, there is no orientation in their work process.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-12-27, 1398/10/06
Ethics committee reference number
IR.TUMS.VCR.REC.1398.1003
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Severity of schizophrenia
Timepoint
Baseline and weeks 4 and 8
Method of measurement
By Positive and Negative Syndrome Scale (PANSS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Subcutaneous injection of Adalimumab (40 mg) (CinnaGen, Tehran) by pen-injector at weeks 0 and 4
Category
Treatment - Drugs
2
Description
Control group: Subcutaneous injection of normal saline as placebo at weeks 0 and 4
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Roozbeh hospital
Full name of responsible person
Prof. Mohammad Reza Mohammadi
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
mohammadimr@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Qhods St., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
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
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2021 to 2026
To whom data/document is available
academic researchers
Under which criteria data/document could be used
users should cite the resource of data
From where data/document is obtainable
Prof Shahin Akhondzadeh
What processes are involved for a request to access data/document