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Trial registered on ANZCTR


Registration number
ACTRN12614000869673
Ethics application status
Approved
Date submitted
17/07/2014
Date registered
13/08/2014
Date last updated
13/08/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of flouxetine versus citalopram on sexual dysfunction, serum oxytocin and prolactin levels in women
Scientific title
Sexual dysfunction, serum oxytocin and prolactin level in women with diagnosis of depression treated with flouxetine or citalopram
Secondary ID [1] 285004 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual dysfunction 292511 0
Depression 292645 0
Condition category
Condition code
Reproductive Health and Childbirth 292818 292818 0 0
Other reproductive health and childbirth disorders
Mental Health 292956 292956 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Administration arm1:oral tablet of flouxetine 20 mg/day for 4 weeks or arm 2: oral tablet of citalopram 20 mg/day for 4 weeks both for treatment of major depressive disorder in women. Adherence monitoring will be done by counting tablet return by patients.
Intervention code [1] 289837 0
Treatment: Drugs
Comparator / control treatment
Fluoxetine group
Control group
Active

Outcomes
Primary outcome [1] 292677 0
Using Female Sexual Function Index(FSFI) questionairre for assesment of sexual dysfunction
Timepoint [1] 292677 0
After 4 weeks of treatment either with flouxetine or citalopram
Secondary outcome [1] 309492 0
assesment of oxytocin in serum of studied patients
Timepoint [1] 309492 0
After 4 weeks of treatment with either flouxetine or citalopram
Secondary outcome [2] 309728 0
Assessment of prolactin in serum of studied patient
Timepoint [2] 309728 0
After 4 weeks of treatment with either fluoxetine or citalopram

Eligibility
Key inclusion criteria
All women need to be experiencing symptoms of sexual dysfunction with diagnosis of depression between 18-45 years old in the psychosomatic clinic of Taleghani hospital(Tehran, Iran) with informed consent
Minimum age
18 Years
Maximum age
45 Years
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
patients with renal failure or hepatic failure, pregnat or breast feeding women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6223 0
Iran, Islamic Republic Of
State/province [1] 6223 0

Funding & Sponsors
Funding source category [1] 289619 0
University
Name [1] 289619 0
Shahid Beheshti University of Medical Sciences
Address [1] 289619 0
Department of clinical pharmacy, school of pharmacy, valiasr street, nyayesh junction, Tehran, Iran, 1991953381
Country [1] 289619 0
Iran, Islamic Republic Of
Primary sponsor type
Individual
Name
Mohammad Abbasinazari
Address
Department of clinical pharmacy, school of pharmacy,Shahid Beheshti University of Medical Sciences, valiasr street, nyayesh junction, Tehran, Iran, 1991953381
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 288306 0
University
Name [1] 288306 0
Deputy of research of Shahid Beheshti university of medical sciences
Address [1] 288306 0
Deputy of research, School of pharmacy, valiasr street, nyayesh junction, Tehran, Iran, 1991953381
Country [1] 288306 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291361 0
Shahid Beheshti University of Medical Sciences ethical committee
Ethics committee address [1] 291361 0
Ethical comittee center, school of pharmacy, valiasr street, nyayesh jnction, Tehran, Iran, 1991953381
Ethics committee country [1] 291361 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 291361 0
27/06/2012
Approval date [1] 291361 0
27/06/2012
Ethics approval number [1] 291361 0

Summary
Brief summary
Sexual dysfunction is an important adverse drug reactions of selective serotonin reuptake inhibitor(SSRIs) drugs. In some limited animal studies sexual dysfunction has been related to changes in oxytocin and prolactin levels due to usage of SSRIs. Flouxetine can cause more suppression in oxytocin than citalopram and less suppression in prolactin than citalopram. It has been postulated that decrease in oxytocin and increase in prolactin is responsible for more sexual abnormality adverse effects by fluoxetine versus citalopram. In this study we have selected some depressed women who need to starting an SSRIs. We randomized depressed women to give either fluoxetine 20 mg/day or citalopram 20 mg/day. After 4 weeks we have determined sexual dysfunction and oxytocin and prolactin levels in both groups. Finally severity of sexual dysfunction and oxytocin and prolactin will be compare in two groups.
Trial website
Trial related presentations / publications
There is not any citation. Now we are writing a manuscript for publication.
Public notes

Contacts
Principal investigator
Name 49998 0
A/Prof Mohammad Abbasinazari
Address 49998 0
Department of clinical pharmacy,School of pharmacy, Shahid Beheshti University of Medical Sciences,Valiasr street, nyayesh junction, Tehran, Iran 1991953381
Country 49998 0
Iran, Islamic Republic Of
Phone 49998 0
+982188873704
Fax 49998 0
Email 49998 0
farshadpharm@yahoo.com
Contact person for public queries
Name 49999 0
A/Prof Mohammad Abbasinazari
Address 49999 0
Department of clinical pharmacy,School of pharmacy, Shahid Beheshti University of Medical Sciences,Valiasr street, nyayesh junction, Tehran, Iran 1991953381
Country 49999 0
Iran, Islamic Republic Of
Phone 49999 0
+982188873704
Fax 49999 0
Email 49999 0
farshadpharm@yahoo.com
Contact person for scientific queries
Name 50000 0
A/Prof Mohammad Abbasinazari
Address 50000 0
Department of clinical pharmacy,School of pharmacy, Shahid Beheshti University of Medical Sciences,Valiasr street, nyayesh junction, Tehran, Iran 1991953381
Country 50000 0
Iran, Islamic Republic Of
Phone 50000 0
+982188873704
Fax 50000 0
Email 50000 0
farshadpharm@yahoo.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary