To assess the effect of topiramate on weight change and metabolic syndrome in obese patients with schizophrenia and schizoaffective disorder
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 2 on 66 patients. Random allocation software was used for randomization.
Settings and conduct
This study is an experimental study of double-blind controlled clinical trial (RCT) using placebo in all patients with schizophrenia and schizoaffective hospitalization in men and women wards of Razi Psychiatric Hospital. Individuals are selected based on inclusion criteria and then randomly divided into intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 65 years
BMI above 27
schizophrenia or schizoaffective disorder
Obtaining informed consent from the patient and the patient's legal guardian
Inclusion criteria:
Diabetes
Pregnancy or breastfeeding
Unmodified thyroid disease
Patients with heart failure
Patients with kidney problems
Hypersensitivity to topiramate
Patient reluctance
Use of iodinated contrast agents during the last 1 month
Alcohol and drug addiction
Intervention groups
Participants will be randomly (in alphabetical order) divided into two groups of men and women, and each of these groups will be divided into intervention and control groups. Topiramate 50 mg tablets of Aria Pharmaceutical Company and placebo in the form of uniformly packed tablets And will be presented to patients with the names of A and B by the center nurse.
Main outcome variables
It is expected that the following variables change in the Intervention group after the intervention.
Patients' weight
BMI
Abdomen circumference
Fasting blood cholesterol level
HDL (High Density Cholesterol)
LDL (Low Density Cholesterol)
-TG (triglyceride)
-FBS
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210622051665N1
Registration date:2021-07-25, 1400/05/03
Registration timing:retrospective
Last update:2021-07-25, 1400/05/03
Update count:0
Registration date
2021-07-25, 1400/05/03
Registrant information
Name
Hamidreza Kamravan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6683 4793
Email address
kamravan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-09-10, 1399/06/20
Actual recruitment start date
2020-02-21, 1398/12/02
Actual recruitment end date
2020-09-23, 1399/07/02
Trial completion date
2020-09-23, 1399/07/02
Scientific title
Topiramate’s effectiveness on weight reduction and metabolic syndrome in obese patients with schizophrenia and schizoaffective
Public title
Topiramate’s effectiveness on weight reduction and metabolic syndrome in obese patients with schizophrenia and schizoaffective
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 65 years
BMI above 27
Patients with schizophrenia or schizoaffective disorder receiving a second-generation antipsychotic drug
Obtaining informed consent from the patient and the patient's legal guardian
Exclusion criteria:
Diabetis
Pregnancy or breastfeeding
Patients with heart failure
Patients with kidney disease
Hypersensitivity to topiramate
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
70
Actual sample size reached:
66
Randomization (investigator's opinion)
Randomized
Randomization description
The collected samples were randomly divided into two groups based on the random sequence created in the Random allocation software to the drug and placebo.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, sampling is performed by the researcher and the interventions are performed by the nurse. Also, the sampler does not know that the sample is part of the control or intervention group.The patients in this study are also unaware of being in the intervention or control group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Social Welfare and Rehabilitation Sciences University of Medical Sciences
Street address
kodakyar Ave., daneshjo Blvd.,Evin
City
Tehran
Province
Tehran
Postal code
1985713871
Approval date
2020-01-15, 1398/10/25
Ethics committee reference number
IR.USWR.REC.1399.250
Health conditions studied
1
Description of health condition studied
Schizophrenia,Schizoaffective
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
BMI>27
Timepoint
before study and in weeks 4,8 and 12
Method of measurement
measure height and weight
2
Description
measure abdominal circumference
Timepoint
before study and in weeks 4,8 and 12
Method of measurement
Tape meter
3
Description
FBS
Timepoint
before the study and in weeks 4,8 and 12
Method of measurement
Blood sample and lab result
4
Description
Total cholesterol
Timepoint
before the study and in weeks 4,8 and 12
Method of measurement
Blood sample and lab result
5
Description
Triglyceride
Timepoint
before the study and in weeks 4,8 and 12
Method of measurement
Blood sample and lab result
Secondary outcomes
empty
Intervention groups
1
Description
Patients were randomly divided (in alphabetical order) into two groups of men and women, and each of these groups was divided into intervention and control groups. A total of 33 patients entered the intervention group. In order to observe the ethical issues of diet and the amount of appropriate daily activity, the condition of all patients was observed based on consultation with a nutritionist and similar conditions were established in the two groups of topiramate and control. Topiramate 50 mg tablets of Aria Pharmaceutical Company were packaged in the same shape as tablets and presented to the patients by the center nurse. Initially one capsule daily in the morning and after one week, two daily capsules (one capsule in the morning and one capsule in the evening) will be given until the end of week 12.
Category
Treatment - Drugs
2
Description
Control group: Patients were randomly divided (in alphabetical order) into two groups of men and women, and each of these groups was divided into intervention and control groups. A total of 33 patients entered the intervention group. In order to observe the ethical issues of diet and the amount of appropriate daily activity, the condition of all patients was observed based on consultation with a nutritionist and similar conditions were established in the two groups of topiramate and control. The placebo pill was packaged in the same shape as the tablets and presented to the patients by the center nurse. Initially one capsule daily in the morning and after one week, two daily capsules (one capsule in the morning and one capsule in the evening) will be given until the end of week 12.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Hamidreza Kamravan
Street address
Shahr Rey, Shahid Rastegar Boulevard
City
Tehran
Province
Tehran
Postal code
1866958891
Phone
+98 21 3340 1222
Email
kamravan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Kamravan
Street address
Tehran, Shahreri, Shahid Rastegar Boulevard
City
Tehran
Province
Tehran
Postal code
1345935775
Phone
+98 21 6683 4793
Email
kamravan@gmail.com
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
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Kamravan
Position
psychiatric resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Tehran, Shahreri, Shahid Rastegar Boulevard
City
Tehran
Province
Tehran
Postal code
1345935775
Phone
+98 21 6683 4793
Email
kamravan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Kamravan
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Azarbayejan, Foad moosavi street, bani asadi Avenue, No 7.
City
Tehran
Province
Tehran
Postal code
1345935775
Phone
+98 21 6683 4793
Fax
Email
kamravan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Kamravan
Position
Psychiatry resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
Azarbayejan, Foad moosavi street, bani asadi Avenue, No 7.
City
Tehran
Province
Tehran
Postal code
1345935775
Phone
+98 21 6683 4793
Fax
Email
kamravan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available