Objective: to compare the sexual side effects of treatment with Fluoxetine, Sertraline and Trazodone. Subjects are outpatients referred to psychiatric clinic who meet criteria of non psychotic major depressive disorder according to DSM-IV-TR with a score of 16 on Hamilton rating scale for depression. One hundred two patients are randomly divided into three groups and any group is treated with one of these antidepressants :Fluoxetine, Sertraline or Trazodone. Any group consists of 34 patients (17 men, 17 women). Patients are physically healthy with no concurrent medical illness and have been free of anti depressant (and other psychotropic) medication for at least 5 weeks before the initial visit. Sexual function questionnaire and HAM-D are filled for each patient in baseline. Clinician provides standard management in a clinical visit every 4 weeks while repeat measures of HAM-D and SFQ (sexual functioning questionnaire) up to 8-14 weeks after the treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138810281522N3
Registration date:2010-06-24, 1389/04/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-24, 1389/04/03
Registrant information
Name
Habibolah Khazaie
Name of organization / entity
Department of Psychiatry, Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1838 4185
Email address
ha_khazaie@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kermanshah University of Medical Sciences and Health Services
Expected recruitment start date
2009-12-01, 1388/09/10
Expected recruitment end date
2010-03-01, 1388/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of sexual side effects of treatment with Fluoxetine, Sertraline and Trazodone
Public title
Comparison of side effects of antidepressants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: major depressive disorder, being physically healthy. Exclusion criteria: concurrent active medical illness, antidepressant and anti psychotic medication for at least 5 weeks before initial study visit.
Age
No age limit
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethical Comitte of Kermanshah University of Medical Sciences and Health Servises
Street address
Shahid Beheshti boulevard
City
Kermanshah
Postal code
Approval date
2009-11-30, 1388/09/09
Ethics committee reference number
37566/420/7/پ
Health conditions studied
1
Description of health condition studied
Major depression disorder
ICD-10 code
F32
ICD-10 code description
Depressive episode
Primary outcomes
1
Description
Sexual side effects
Timepoint
8-14 weeks
Method of measurement
sexual function questionare (sfq)
Secondary outcomes
1
Description
Response to treatment
Timepoint
4 weeks
Method of measurement
HAMILTON rating scale
Intervention groups
1
Description
Fluoxetine 20-40mg
Category
Treatment - Drugs
2
Description
Sertralin 50-200mg
Category
Treatment - Drugs
3
Description
Trazodone 200-300mg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospital clinic
Full name of responsible person
Nastaran Rezaei payam
Street address
Farabi Hospital
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Kermanshah University of Medical Sciences
Full name of responsible person
Dr Farid Najafi
Street address
Shahid Beheshti Blvd
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Kermanshah 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
Farabi hospital, Kermanshah university of medical science
Full name of responsible person
Dr Habibolla Khazaie
Position
psychiatrist/assotiate professor/chairman
Other areas of specialty/work
Street address
Farabi hospital
City
Kermanshah
Postal code
6719851151
Phone
+98 83 1826 4512
Fax
Email
ha_khazaie@kums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah university of medical science
Full name of responsible person
Dr. Habiballah Khazaie
Position
National board of psychiatry
Other areas of specialty/work
Street address
Farabi Hospital
City
Kermanshah
Postal code
6719851151
Phone
+98 83 1826 4512
Fax
Email
ha_khazaie@kums.ic.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah university of medical sciences
Full name of responsible person
Nastaran Rezaie payam
Position
resident of psychiatry
Other areas of specialty/work
Street address
Farabi hospital, Ashier blvd
City
Kermanshah
Postal code
Phone
+98 83 1826 4512
Fax
Email
nrezaie@kums.ac.ir
Web page address
kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)