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IRCT20140102016035N3 IRCT 2019-07-03 Rasht University of Medical Sciences Metformin and Body Mass Index of Patients under Treatment with SSRI 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 2019-07-06 anticipated 60 Complete https://irct.ir/trial/40317 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 Condition 1: Obesity. Condition 2: Depression. Condition 3: Anxiety Disorders. Intervention 1: 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). Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Only part of the data, such as the key outcome information or the like, can share. When: The beginning of the access period since early 1399 To whom: It will be available to doctors and researchers working in academic and academic institutions. Conditions: 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. Where to obtain: Email to head of project How to obtain: After the email is submitted to the head of project, the requesting person will receive the response within a few days. Comments:
public Somayeh Shokrgozar
Shafa Hospital, 15khordad St.
Rasht Iran (Islamic Republic of) 41939-55599 +98 13 3366 6268 Dr.shokrgozar@yahoo.com Rasht University of Medical Sciences scientific Somayeh Shokrgozar
Shafa Hospital, 15khordad St.
Rasht Iran (Islamic Republic of) 41939-55599 +98 13 3366 6268 Dr.shokrgozar@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) 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 no limit no limit Both Addiction Having metabolic disorders E66.1 F32.2 F41 Drug-induced obesity Major depressive disorder, single episode, severe without psychotic features Other anxiety disorders Treatment - Drugs Treatment - Drugs 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). 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. 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. 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. 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. 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. 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. 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). 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. 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. Rasht University of Medical Sciences Approved 2019-06-12 Ethics committee of Guilan University of Medical Sciences Deputy of Research and Technology University, The old building of the School of Health, in front of 17shahrivar Hospital, Shahid Siadati St., Namjoo St Rasht Guilan Iran (Islamic Republic of)