Sexual Dysfunction
Conditions
Keywords
trazodone, SSRI, sexual dysfunction, 5-HT2A polymorphism
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.
Interventions
DRUGTrazodone
50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained
DRUGPlacebo
Placebo
Sponsors
Beitou Armed Forces Hospital, Taipei, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | week 0 and week 6 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The association between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were evaluated. | week 6 | The secondary domains assessed were the difference between trazodone and placebo in the Clinical Global Impression scale, 10-point Visual Analogue Scale, Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scale at the end of week 6. Besides, relationships between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were also evaluated. |
Countries
Taiwan
Outcome results
None listed