Clinical Trial Of Investigation of Efficacy of Metformin on the Body Mass Index of Patients under Treatment with Selective Serotonin Re uptake Inhibitors Drugs Referred to Psychiatry Clinics of Rasht
This study was designed to evaluate the effect of metformin on body mass index of patients undergoing SSRI in a randomized clinical trial.
Design
Patients will be included in the study after obtaining informed consent with admission and admission criteria. Then, 60 overweight subjects will be allocated randomly to the study groups (the metformin receiving group, the control group, and the lack of metformin). If the patients in the control group suffer from metabolic disorders requiring treatment, Are excluded. This study is in phase 3 and patients and therapists are aware of the study.
Settings and conduct
The location of the study is Shafa Psychiatric Hospital of Rasht. After sampling by available method, the specimens were randomly divided into two groups of case and control. The intervention will be given to certain people who have changed weight and body mass index for taking serotonin re uptake inhibitors, and a certain dose of metformin is given.
Participants/Inclusion and exclusion criteria
patients with anxiety and depression who referred to the Psychiatric Center.
Inclusion criteria:
1- Obtain informed.2-No history of side effects with metformin and Selective serotonin re uptake inhibitor drugs.3- The absence of kidney and liver disorders. 4-The absence of a physical illness. 5- No taking Corticosteroids. 6-The absence of psychotic features. Exclusion criteria: Having Metabolic disorders (Without taking metformin), addiction
Intervention groups
Intervention group: The metformin is given to the intervention group. The usual treatment (fluoxetine , sertraline , paroxetine with a maximum daily dose) will also be received. Control group: Control subjects receive only routine treatment (fluoxetine treatment, sertraline, paroxetine with a maximum daily dose).
Main outcome variables
Changes in body mass index and Anthropometric indices due to metformin use.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140102016035N3
Registration date:2019-07-03, 1398/04/12
Registration timing:prospective
Last update:2019-07-03, 1398/04/12
Update count:0
Registration date
2019-07-03, 1398/04/12
Registrant information
Name
somayeh shokrgozar
Name of organization / entity
guilan university of madical sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1666 6628
Email address
dr_shokrgozar@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2020-01-05, 1398/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial Of Investigation of Efficacy of Metformin on the Body Mass Index of Patients under Treatment with Selective Serotonin Re uptake Inhibitors Drugs Referred to Psychiatry Clinics of Rasht
Public title
Metformin and Body Mass Index of Patients under Treatment with SSRI
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtain informed consent from patients
No history of side effects with metformin and SSRI drugs
The absence of kidney and liver disorders
The absence of a physical illness such as diabetes and Autoimmune disease
No taking Corticosteroids
Not taking any type of drug and stimulant
The absence of psychotic features
Exclusion criteria:
Addiction
Having metabolic disorders
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
After determining overweight patients, a psychiatric assistant will randomly divide them into two groups of intervention and control. Patients with the ability to enter this clinical trial are categorized as 1 to 1 in two groups of intervention and control. Given that the total number of samples is 60, the randomization process is performed using 15 blocks of four. Both groups of patients will be described in terms of how to study and receive or not receive metformin.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Deputy of Research and Technology University, The old building of the School of Health, in front of 17shahrivar Hospital, Shahid Siadati St., Namjoo St
City
Rasht
Province
Guilan
Postal code
41446-66949
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.GUMS.REC.1398.097
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.1
ICD-10 code description
Drug-induced obesity
2
Description of health condition studied
Depression
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
3
Description of health condition studied
Anxiety Disorders
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
Fasting Blood Glucose
Timepoint
At the start of treatment, in the third and sixth months of follow up, fasting blood glucose (Kate: Pars Test) will be measured by a psychiatrist's assistant and will be recorded in the patient records.
Method of measurement
Fasting blood glucose (kits: pars test), are measured by a psychiatrist's assistant.
2
Description
Cholesterol
Timepoint
At the start of treatment, in the third and sixth months of follow up, Cholesterol (Kate: Pars Test) will be measured by a psychiatrist's assistant and will be recorded in the patient records.
Method of measurement
Cholesterol(kits: pars test), are measured by a psychiatrist's assistant.
3
Description
Triglyceride
Timepoint
At the start of treatment, in the third and sixth months of follow up, Triglyceride (Kate: Pars Test) will be measured by a psychiatrist's assistant and will be recorded in the patient records.
Method of measurement
Triglyceride (kits: pars test), are measured by a psychiatrist's assistant.
4
Description
Height
Timepoint
At the onset of treatment, in the third and sixth months of follow up, the height (By centimeters) will be measured by the assistant psychiatrist.
Method of measurement
The height (By centimeters) will be measured by the assistant psychiatrist.
5
Description
Weight
Timepoint
At the start of treatment, in the third and sixth months of follow-up, the weight (measured by the digital scale of the Race of Germany, with a precision of one tenth kilogram) will be measured by the assistant psychiatrist.
Method of measurement
The weight (measured by the digital scale of the Race of Germany, with a precision of one tenth kilogram) will be measured by a psychiatrist's assistant.
6
Description
Body Mass Index
Timepoint
At the start of treatment, in the third and sixth follow up, the BMI will be measured by the psychiatrist's assistant (by the formula for dividing the body weight per kg by the second strength per meter).
Method of measurement
The BMI will be measured by the psychiatrist's assistant (by the formula for dividing the body weight per kg by the second strength per meter).
7
Description
Waist
Timepoint
At the start of treatment, in the third and sixth follow up, the waist (measured by centimeters) will be measured by the psychiatrist's assistant.
Method of measurement
The waist (measured by centimeters) will be measured by the psychiatrist's assistant.
8
Description
Wrist
Timepoint
At the start of treatment, in the third and sixth follow up, the wrist (measured by centimeters) will be measured by the psychiatrist's assistant.
Method of measurement
The wrist (measured by centimeters) will be measured by the psychiatrist's assistant.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The Metformin that produced by the Rohamet Pharmaceutical Company, is given to the intervention group. At baseline, third and sixth month of follow-up, Weight, body mass index, waist size, wrist circumference, FBS of patients will be measured by a psychiatrist's assistant. The dose of metformin, according to previous studies, is 250 mg daily, which is based on studies of the maximum daily dose of metformin. Before lunch, metformin is given and after 4 days, it increases to 250 mg twice daily before lunch and dinner and Finally, a maximum of 2,250 mg per day is increased in three divided doses before breakfast, lunch and dinner. Patients will receive routine drug treatment (SSRI treatment).
Category
Treatment - Drugs
2
Description
Control group: The intervention in the control group will be routinely treated (Treatment with selective serotonin re uptake inhibitors) and no additional work will be done.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
University Clinics of Psychiatry (Shafa psychiatric Hospital) And private psychiatric clinic in Rash
Full name of responsible person
Somayeh Shokrgozar
Street address
Shafa Hospital, 15khordad St., Rasht
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
Dr.shokrgozar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Shadman Nemati
Street address
Deputy of Research and Technology University, The old building of the School of Health, in front of 17 shahrivar Hospital, Shahid Siadati St., Namjoo St.
City
Rasht
Province
Guilan
Postal code
41446-66949
Phone
+98 13 3333 6394
Email
nemati@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Somayeh Shokrgozar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shafa Hospital, 15khordad St.
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
Dr.shokrgozar@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Somayeh Shokrgozar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
Shafa Hospital, 15khordad St.
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
Dr.shokrgozar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Aida Yahyazadeh
Position
Research expert
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shafa Hospital, 15khordad St.
City
Rasht
Province
Guilan
Postal code
41939-55599
Phone
+98 13 3366 6268
Email
aidayahyazadeh@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
Undecided - It is not yet known if there will be 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
Only part of the data, such as the key outcome information or the like, can share.
When the data will become available and for how long
The beginning of the access period since early 1399
To whom data/document is available
It will be available to doctors and researchers working in academic and academic institutions.
Under which criteria data/document could be used
Eligible persons can send their application by e-mail to access relevant information so that they can be sent to them if they identify the project implementer.
From where data/document is obtainable
Email to head of project
What processes are involved for a request to access data/document
After the email is submitted to the head of project, the requesting person will receive the response within a few days.