The objective of this randomized double-blind clinical trial is to investigate the effect of sertraline on the hormonal change and depressiona in Polycysitic ovarian syndrome (PCOS).
Design
Randomized double blind and placebo-controlled clinical trial
Settings and conduct
The study will be conducted among adults with major depressive disorder attending Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Women with PCOS diagnosed by the Rotterdam consensus criteria (Presence of 2 of the following 3 conditions: i. amenorrhea /oligomenorrhea ii. clinical or biochemical evidence of hyperandrogenism iii. Polycystic ovaries on ultrasound examination), 2-mild to moderate major depressive disorder based on DSM-5 criteria 3- score on hamilton depression scaleequals or less than 18 4-Increased serum level of prolactin( more than 20 ng/dl)
Exclusion criteria: 1-psychotic symptoms 2-presence of any other mental disorder 3-receiving any antidepressant treatment during the last 6 weeks 4-thyroid diseases 6- breast feeding or pregnancy
Intervention groups
The participants will be randomly allocated into two groups. Intervention group(20 persons) will receive sertraline ( 100 mg per day) and control group ( 20 persons) will receive placebo for 6 weeks.
Main outcome variables
Severity of depression
serum level of prolactin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090117001556N123
Registration date:2019-10-27, 1398/08/05
Registration timing:prospective
Last update:2019-10-27, 1398/08/05
Update count:0
Registration date
2019-10-27, 1398/08/05
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-05, 1398/08/14
Expected recruitment end date
2020-09-04, 1399/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of sertralin on the depression and of serum prolactin levels among PCOD patients
Public title
The effect of sertralin on the depression and of serum prolactin levels among PCOD patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Women with PCOS diagnosed by the Rotterdam consensus criteria (Presence of 2 of the following 3 conditions: i. amenorrhea /oligomenorrhea ii. clinical or biochemical evidence of hyperandrogenism iii. Polycystic ovaries on ultrasound examination)
Mild to moderate major depressive disorder based on DSM-5 criteria
Score on Hamilton depression scale <18
Women aged 18-60 years
Increased serum level of prolactin ( more than 20 ng per dl)
Exclusion criteria:
Psychotic symptoms
Presence of any other mental disorder
Receiving antidepressant treatment during the last 6 weeks
Breastfeeding or pregnancy
Thyroid diseases
Age
From 18 years old to 60 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random permuted block
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants, clinicians and outcome raters will be blind regarding grouping
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2019-10-03, 1398/07/11
Ethics committee reference number
IR.TUMS.VCR.REC.1397.1106
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Severity of depression
Timepoint
Baseline and weeks 4 and 6 after beginning of treatment
Method of measurement
Hamiltion Depression Rating Scale 17-Item
2
Description
Serum level of prolactin
Timepoint
Baseline and weeks 4 and 6 after beginning of treatment
Method of measurement
ICMA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: tablet sertralin 100 mg/day as intervention group for 6 weeks
Category
Treatment - Drugs
2
Description
Control group: placebo as control group for 6 weeks
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
psycho somatic clinic-Imam Khomeini Hospital
Full name of responsible person
Prof. Ahmad Ali Noorbala Tafti
Street address
Dr Qharib street, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 0000
Email
noorbala@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Tehran University of Medical Sciences, Keshavarz Blv
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Professor of clinical psychopharmacology
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Roozbeh Hospital, South Kargar Street, Tehran
City
Tehran
Province
Tehran
Postal code
1333715914
Phone
+98 21 5541 2222
Fax
+98 21 5541 9113
Email
s.akhond@sina.tums.ac.ir
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
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The data will be distributed through final report
When the data will become available and for how long
5 years from 2021 to 2026
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
by citing the resourse
From where data/document is obtainable
Professor Shahin Akhondzadeh
What processes are involved for a request to access data/document