Trazodone for SSRI-sexual Dsyfunction
Information source: Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sexual Dysfunction
Intervention: Trazodone (Drug); Placebo (Drug)
Phase: N/A
Status: Completed
Sponsored by: Beitou Armed Forces Hospital, Taipei, Taiwan Official(s) and/or principal investigator(s): Kuo-Tung Chiang, M.D., Study Director, Affiliation: Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
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.
Clinical Details
Official title: The Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-induced Sexual Dysfunction
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: The association between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were evaluated.
Eligibility
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
Inclusion criteria were:
1. 20-65 years of age,
2. receiving SSRI treatment for more than four weeks,
3. minimal dose of fluoxetine, paroxetine, and citalopram are 20 mg/d, minimal dose of
fluvoxamine and sertraline are 50 mg/d, and minimal dose of escitalopram is 10mg/d,
4. developing sexual dysfunction based on the definition of Arizona Sexual
Experience-Chinese Version.
Exclusion criteria were:
1. receiving other antidepressant agents,
2. receiving antipsychotics,
3. having a currently unstable medical condition such as unstable angina or uncontrolled
diabetes,
4. 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,
5. being pregnant or planning to become pregnant during the study period,
6. experiencing psychotic symptoms,
7. being comorbidity with substance abuse, (8) developing sexual dysfunction before
receiving SSRIs treatment.
Locations and Contacts
Department of Psychiatry, Beitou Armed Forces Hospital, Taipei 11243, Taiwan
Additional Information
Starting date: April 2010
Last updated: April 23, 2012
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