The effect of Rosiglitazone as an adjuvant therapy on the improvement of negative symptoms in patients with chronic schizophrenia: A randomized, double-blind, placebo-controlled trial
Investigating the effect of Rosiglitazone on negative symptoms in schizophrenia
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
This study will be conducted among patients who have chronic schizophrenia and refer to Razi Hospital of The University of Social Welfare and Rehabilitation Sciences
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diagnosis of schizophrenia based on DSM-5 - Age between 18-50 - At least 2 years have been passed since the diagnosis - Have been stable with risperidone treatment for at least 2 months - Normal ECG. Exclusion criteria: Head trauma - History of shock therapy during the last three months - Neurosurgery - Diagnosis of acute or chronic systemic disease - Alcohol or drug addiction in the last 6 months - Suicidal ideation - Pregnancy or lactation - IQ less than 70 based on the diagnosis of a psychiatrist - ECT during recent two months - Taking oral antipsychotics, excluding risperidone, in the past week or long-acting antipsychotics in the past month - The presence of another diagnosis in axis II - History of heart disease - Family history of heart disease and heart failure - Taking insulin - Liver disorders - The development of a drug complication that requires emergency action: edema, congestive heart failure, heart pain and changes in the basic ECG, hypoglycemia, the occurrence of malignant neuroleptic syndrome.
Intervention groups
Control group: treated with risperidone 2 mg three times a day + placebo for 8 weeks
Intervention group: treated with risperidone 2 mg three times a day + Rosiglitazone 30 mg a day for 8 weeks.
Main outcome variables
Severity of schizophrenia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N159
Registration date:2024-06-23, 1403/04/03
Registration timing:prospective
Last update:2024-06-23, 1403/04/03
Update count:0
Registration date
2024-06-23, 1403/04/03
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
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2026-09-23, 1405/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Rosiglitazone as an adjuvant therapy on the improvement of negative symptoms in patients with chronic schizophrenia: A randomized, double-blind, placebo-controlled trial
Public title
The effect of Rosiglitazone on negative symptoms in schizophrenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of schizophrenia based on DSM-5
Age between 18-50
At least 2 years have been passed since the diagnosis
Have been stable with risperidone treatment for at least 2 months
Normal ECG
Exclusion criteria:
Head trauma
History of shock therapy during the last three months
Neurosurgery
Diagnosis of acute or chronic systemic disease
Alcohol or drug addiction in the last 6 months
Suicidal ideation
Pregnancy or lactation
IQ less than 70 based on the diagnosis of a psychiatrist
ECT during recent two months
Taking oral antipsychotics, excluding risperidone, in the past week or long-acting antipsychotics in the past month
The presence of another diagnosis in axis II
History of heart disease
Family history of heart disease and heart failure
Taking insulin
Liver disorders
The development of a drug complication that requires emergency action: edema, congestive heart failure, heart pain and changes in the basic ECG, hypoglycemia, the occurrence of malignant neuroleptic syndrome
Age
From 18 years old to 50 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).
The best way to create randomization is to use random allocation. Random allocation in clinical trial studies refers to the process of randomly dividing participants into different groups. Randomization gives each participant an equal chance to participate in each group. Successful randomization requires that researchers and study participants be unable to predict the type of intervention received.
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 the University of Social Welfare and Rehabilitation Sciences
Street address
Koodakyar St., Daneshjoo Blvd., Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2024-05-29, 1403/03/09
Ethics committee reference number
IR.USWR.REC.1403.062
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
Control group: treated with risperidone 2 mg three times a day + placebo for 8 weeks
Category
Placebo
2
Description
Intervention group: treated with risperidone 2 mg three times a day + Rosiglitazone 30 mg a day for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Dr. Morvarid Ahadi
Street address
Shahr-e Ray, Shahid Rostgar Blvd
City
Tehran
Province
Tehran
Postal code
1867612016
Phone
+98 912 327 1682
Email
morvaridahadi1360@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khankeh
Street address
Tehran, Evin, Student Blvd, Koodakyar deadend
City
Tehran
Province
Tehran
Postal code
1985713871
Phone
+98 912 376 7147
Email
Hamid.khankeh@ki.se
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
Dr. 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
Dr. 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
Dr. 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
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 2024 to 2029
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