Trazodone for SSRI-sexual Dsyfunction

Study Overview
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Brief Summary
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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.

Official Title
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The Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-induced Sexual Dysfunction

Conditions
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Sexual Dysfunction

Intervention / Treatment
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* Drug: Trazodone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria were: 20-65 years of age, receiving SSRI treatment for more than four weeks, 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, developing sexual dysfunction based on the definition of Arizona Sexual Experience-Chinese Version. Exclusion criteria were: receiving other antidepressant agents, receiving antipsychotics, having a currently unstable medical condition such as unstable angina or uncontrolled diabetes, 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, being pregnant or planning to become pregnant during the study period, experiencing psychotic symptoms, being comorbidity with substance abuse, (8) developing sexual dysfunction before receiving SSRIs treatment.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trazodone<br>Trazodone versus placebo in a randomized, double-blind manner | Drug: Trazodone<br>* 50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained<br>|
| Placebo Comparator: Placebo<br>Patients received placebo | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The association between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were evaluated. | 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. | week 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trazodone, SSRI, sexual dysfunction, 5-HT2A polymorphism