Clinical trial to investigate the efficacy of insulin resistance treatment with the metformin in improving mood disorders in patients with polycystic ovarian syndrome
The aim of this study is to determine the association between treatments with metformin in insulin resistance polycystic ovarian syndrome (PCOS) patients with mood disorder. In this study, patients with PCOS older than 15 years old randomly selected and after consent are consciously enter our study. The study inclusion criteria: patients with PCOS who meet the Rotterdam criteria; with top 10 score in Anxiety Inventory and top 14 score in the Beck Depression Inventory and Exclusion criteria: patient's consent to continue the study; patients who have been treated PCOS over recent 3 months; patients treated with anxiety disorders and depression; patients with diabetes; Patients with Cushing disease; hyperprolactinemia; congenital adrenal hyperplasia; Patients with serious illnesses and life threatening disease (including cancer, cirrhosis, renal failure; severe heart failure class 3 and 4 serious lung disease) ; pregnancy and lactation. At baseline, insulin resistance using Homa IR will be determined by (fasting plasma insulin×fasting plasma glucose )/22.5 is obtained. Then, in patients who are insulin-resistant (Homa IR index greater than 2.5), mood disorders through questionnaires will be checked. And patients with a score of 14 in the Beck Depression Inventory and score of 10 in the anxiety Beck questionnaire will be chosen and after obtaining informed consent for the study will be selected for 3 months treatment with metformin doses of 1,500 mg. Initiationally metformin is prescribed with 500 mg daily then titrated to 1,500 mg over three weeks and continued up to three months. At the end of three months of treatment, re-evaluate the patient. The insulin resistance by Homa IR and depression and anxiety using the relevant questionnaire will be determined and will be compared results before and after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601106710N6
Registration date:2016-03-13, 1394/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Mitra Niafar
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7850
Email address
niafarm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Tabriz University of Medical Sciences
Expected recruitment start date
2016-02-19, 1394/11/30
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to investigate the efficacy of insulin resistance treatment with the metformin in improving mood disorders in patients with polycystic ovarian syndrome
Public title
The evaluation of relationship between insulin resistance and mood disorders in patients with polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with PCOS who meet the Rotterdam criteria; with top 10 score in Anxiety Inventory and top 14 score in the Beck Depression Inventory.
Exclusion criteria: patient's consent to continue the study; patients who have been treated PCOS over recent 3 months; patients treated with anxiety disorders and depression; patients with diabetes; Patients with Cushing disease; hyperprolactinemia; congenital adrenal hyperplasia; Patients with serious illnesses and life threatening disease (including cancer, cirrhosis, renal failure; severe heart failure class 3 and 4 serious lung disease); pregnancy and lactation.
Age
From 15 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Approval date
2016-01-25, 1394/11/05
Ethics committee reference number
TBZMED.REC.1394.983
Health conditions studied
1
Description of health condition studied
Polycystic ovary syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
anxiety and depression scores
Timepoint
Baseline and three months after treatment with metformin
Method of measurement
Based on questionnaire
Secondary outcomes
1
Description
Insulin resistance
Timepoint
Baseline and three months after treatment with metformin
Method of measurement
Test
Intervention groups
1
Description
In all patients, metformin 1500 mg daily for three months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz, Imam Reza Hospital
Full name of responsible person
Dr.Sevil Gafarzadeh
Street address
Imam Reza Hospital, Gate University, Tabriz, East Azarbaijan
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rashidi
Street address
Vice chancellor for Research of Tabriz University of Medical Sciences,Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mitra Niafar
Position
Endocrinology and Metabolism/ Associate Professor
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
dr_niafar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mitra Niafar
Position
Endocrinology and Metabolism/Associate Professor
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Tabriz university of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
dr_niafar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Sevil Gafarzadeh
Position
Endocrinology and Metabolism Fellow
Other areas of specialty/work
Street address
Department of Endocrinology, Imam Reza Hospital, Gate University, Tabriz, East Azarbaijan
City
Tabriz
Postal code
Phone
+98 41 3335 7850
Fax
Email
Dr_srad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)