NCT01097980CompletedNot Applicable
The Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-induced Sexual Dysfunction
Beitou Armed Forces Hospital, Taipei, Taiwan1 site in 1 country56 target enrollmentStarted: April 2010Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- The differences between trazodone and placebo in the Arizona Sexual Experiences Scale-Chinese Version scale at the end of week 6 were used as the primary study outcomes.
Study Overview
Brief Summary
The aim of this study is to investigate the efficacy of trazodone in the treatment of selective serotonin reuptake inhibitor(s) associated sexual dysfunction. The secondary domains assessed were the relationship between 5-HT2A polymorphism and treatment efficacy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Trazodone
Experimental
Trazodone versus placebo in a randomized, double-blind manner
Intervention: Trazodone (Drug)
Placebo
Placebo Comparator
Patients received placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
The differences between trazodone and placebo in the Arizona Sexual Experiences Scale-Chinese Version scale at the end of week 6 were used as the primary study outcomes.
Time Frame: week 0 and week 6
Secondary Outcomes
- The association between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were evaluated.(week 6)
Investigators
Kuo-Tung Chiang
Department of Psychiatry
Beitou Armed Forces Hospital, Taipei, Taiwan
Study Sites (1)
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