Comperssion with the combined effects of omega _3 and citalopram for depression during menopause in postmenopausal women referred to health centers in Hamadan city in 1391: A double-blind clinical trial
Objective: To compare the efficacy of citalopram combined with omega _3 on depression in menopausal women Design: Double blinded randomized controlled trial Setting: The eligible menopausal women with depression who will refer to selected health centers in 2013. Inclusion criteria: a) Age range 65-45 years; b) Should last at least 12 months of amenorrhea; c) According to DSM-IV criteria for depression are known to be; d) No history of hysterectomy, oophorectomy with radiation therapy; e) Not taking antidepressant medication and hormone therapy during the last 6 months; f) Not sensitive to herbal drug; g) Absence of diabetes and cardiovascular disease; h)The Beck score (10-24). Exclusion criteria: a) Drug intolerance; b) Not complete treatment duration; c) The depression scores higher of 24 at follow-up period.Control: 42 patients will receive 20 mg citalopram with placebo daily for one month. Intervention: 42 patients will receive1 gram of omega-3 and 20 mg citalopram daily for one month. Specific outcome: Evaluation of depression with the Beck scale at the end of the first, second and fourth weeks after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013052113405N1
Registration date:2013-07-22, 1392/04/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2013-07-22, 1392/04/31
Registrant information
Name
Seyyedeh Zahra Masoumi
Name of organization / entity
Hamedan University of Medical Sciences, School of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0150
Email address
zahra.masoomi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Hamadan University of Medical Sciences
Expected recruitment start date
2013-08-22, 1392/05/31
Expected recruitment end date
2014-02-19, 1392/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comperssion with the combined effects of omega _3 and citalopram for depression during menopause in postmenopausal women referred to health centers in Hamadan city in 1391: A double-blind clinical trial
Public title
Effect of omega3 in depression in menopause
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: a) Age range 65-45 years; b) Should last at least 12 months of amenorrhea; c) According to DSM-IV criteria for depression are known to be; d) No history of hysterectomy, oophorectomy with radiation therapy; e) Not taking antidepressant medication and hormone therapy during the last 6 months; f) Not sensitive to herbal drug ; g) Absence of diabetes and cardiovascular disease; h) The Beck score (10-24). Exclusion criteria: a) Drug intolerance; b) Not complete treatment duration; c) The depression scores higher of 24 at follow-up period.
Age
From 48 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan university of Medical Scienses
Street address
Hamedan University of MedicaL Sciences, Fahmideh Ave, Hamedan
City
Hamedan
Postal code
Approval date
2013-05-05, 1392/02/15
Ethics committee reference number
330/9/35/16/پ/د
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F32,F33
ICD-10 code description
Depressive episode, Recurrent depressive disorder
Primary outcomes
1
Description
Depression
Timepoint
Before intervention, 1 ,2 ,4 week after intervention
Method of measurement
Beck Questionnaire
Secondary outcomes
1
Description
Complication of drug
Timepoint
After intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
42 patients will receive1 gram of omega-3 and 20 mg citalopram daily for one month.
Category
Treatment - Drugs
2
Description
42 patients will receive 20 mg citalopram with placebo daily for one month
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hussein Medical Center
Full name of responsible person
Seyyedeh Zahra Masoumi
Street address
Imam Hussein Medical Center, Khezr, Hamedan.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Hamadan University of Medical Sciences
Full name of responsible person
Dr Heidar Tavilani
Street address
Vice-chancellor for Research, Hamadan University of Medical Sciences, Shahid Fahmideh Ave, Hamedan.
City
Hamedan
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, Hamadan 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
Hamedan University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Masoumi
Position
Instrucror, PhD student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Fahmideh Ave, Hamedan
City
Hamedan
Postal code
Phone
+98 81 1838 0150
Fax
+98 81 1838 0447
Email
zahramid2001@yahoo.comzahra.masoomi@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Masoumi
Position
Instructor, PhD student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Fahmideh Ave, Hamedan
City
Hamedan
Postal code
Phone
+98 81 1838 0150
Fax
+98 81 1838 0447
Email
zahramid2001@yahoo; comzahra.masoomi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Seyyedeh Zahra Masoumi
Position
Instructor, PhD student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Fahmide Ave, Hamedan.
City
Hamedan
Postal code
Phone
+98 81 1838 0150
Fax
+98 81 1838 0447
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)