Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000689976
Ethics application status
Approved
Date submitted
5/07/2011
Date registered
7/07/2011
Date last updated
7/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Genetic polymorphism and serotonergic antidepressant related sexual dysfunction
Scientific title
Association study of serotonin receptor single nucleotide polymorphism with serotonergic antidepressant-related sexual dysfunction
Secondary ID [1] 262566 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
SPSASD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sexual dysfunction 268225 0
Major depressive disorder 268227 0
Dysthymic disorder 268228 0
Condition category
Condition code
Mental Health 268356 268356 0 0
Other mental health disorders
Mental Health 268359 268359 0 0
Depression
Renal and Urogenital 268379 268379 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients with depression usually experience sexual dysfunction, which could result from numerous causes, including depression itself, physical illness, comorbid psychiatric disorder, and its treatment, that is, serotonergic antidepressants. This study is to investigate the relationship between serotonin receptor polymorphism and serotonergic antidepressant-induced sexual dysfunction. Cases will be collected prospectively until a total of approximately 100 subjects have been collected. Subjects with major depressive disorder or dysthymic disorder, who receive serotonergic antidepressant(s) will be enrolled in the study. Initially all participants will be rated by the Hamilton Rating Scale for Depression (HAMD) and the Arizona Sexual Experience Scale (ASEX). We use buccal cheek swaps to obtain material for genotyping the A(-1438)G promoter polymorphism of the 5-hydroxytryptamine 2a receptor. We will evaluate all participants using HAMD and ASEX after 4 weeks (or at the time they are discharged from our hospital). Subjects who have response to antidepressant but complain of sexual dysfunction will be compared with those who do not have sexual dysfunction. Sexual dysfunction is defined as having either a score of 5 or more on any item or a total score of 17 or more on ASEX. A total score of 14 or less on HAMD is defined as having response to antidepressant.
Intervention code [1] 266898 0
Not applicable
Comparator / control treatment
Patients without clinically significant depression after serotonergic antidepressant treatment for approximately 4 weeks experiencing sexual dysfunction will be compared with those without sexual dysfunction. Sexual dysfunction is defined as having either a score of 5 or more on any item or a total score of 17 or more on ASEX. A total score of 14 or less on HAMD is defined as having response to antidepressant.
Control group
Active

Outcomes
Primary outcome [1] 269127 0
The Hamilton Rating Scale for Depression (HAMD) is used for assessment of depression status, and sexual dysfunction is rated using the Arizona Sexual Experience Scale (ASEX). Genomic DNA will be isolated from buccal cells collected with cheek brush. We use polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) for genotyping single nucleotide polymorphisms, that is, A(-1438)G polymorphism of 5-hydroxytryptamine 2a receptor.
Timepoint [1] 269127 0
We assess the participants at baseline and week 4. We anticipate that the study will be completed within three months.
Secondary outcome [1] 276986 0
The association between treatment response and gene polymorphism is measured as the secondary outcome. Treatment response is assessed by using the changes in HAMD.
Timepoint [1] 276986 0
We assess the participants at baseline and week 4. We anticipate that the study will be completed within three months.

Eligibility
Key inclusion criteria
1. being diagnosed with major depressive disorder or dysthymic disorder (according to DSM-IV-TR diagnostic criteria)
2. being aged of 18-40
3. receiving serotonergic antidepressant, including sertraline, venlafaxine, citalopram, paroxetine, fluoxetine, duloxetine, escitalopram, milnacipran
4. willing to engage in sexual activity, alone or with a partner, at least weekly for the duration of the study
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. receiving other medications that may cause sexual dysfunction, such as antipsychotics and mood stablizers
2. having any serious medical condition that affects sexual functioning such as epilepsy, serious head injury, brain tumor, HIV infection, Parkinson's disease, dementia, multiple sclerosis, or other neurological disorder
3. being comorbidity with substance abuse
4. developing sexual dysfunction before psychiatric illness

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 3693 0
Taiwan, Province Of China
State/province [1] 3693 0
Taipei city

Funding & Sponsors
Funding source category [1] 267380 0
Hospital
Name [1] 267380 0
Civilian Administration Division of Beitou Armed Forces Hospital
Country [1] 267380 0
Taiwan, Province Of China
Primary sponsor type
Individual
Name
Chih-Sung Liang
Address
No.60, Xinmin Road, Beitou District, Taipei City 112
Country
Taiwan, Province Of China
Secondary sponsor category [1] 266441 0
Individual
Name [1] 266441 0
Kuo-Tung Chiang
Address [1] 266441 0
No.60, Xinmin Road, Beitou District, Taipei City 112
Country [1] 266441 0
Taiwan, Province Of China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269355 0
Institutional Review Board for the Protection of Human Subjects at the Tri-Service General Hospital
Ethics committee address [1] 269355 0
Ethics committee country [1] 269355 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 269355 0
20/12/2010
Approval date [1] 269355 0
02/03/2011
Ethics approval number [1] 269355 0
BAFHM9901

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32831 0
Address 32831 0
Country 32831 0
Phone 32831 0
Fax 32831 0
Email 32831 0
Contact person for public queries
Name 16078 0
Chih-Sung Liang
Address 16078 0
No.60, Xinmin Road, Beitou District, Taipei City 112
Country 16078 0
Taiwan, Province Of China
Phone 16078 0
+886/228959808
Fax 16078 0
+886/2228957633
Email 16078 0
[email protected]
Contact person for scientific queries
Name 7006 0
Chih-Sung Liang
Address 7006 0
No.60, Xinmin Road, Beitou District, Taipei City 112
Country 7006 0
Taiwan, Province Of China
Phone 7006 0
+886/228959808
Fax 7006 0
+886/2228957633
Email 7006 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.