Trazodone for SSRI-sexual Dsyfunction

Beitou Armed Forces Hospital, Taipei, Taiwan56 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Sexual Dysfunction

Interventions

TrazodoneDRUG

50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 (1)

Department of Psychiatry, Beitou Armed Forces Hospital

Taipei, Taiwan

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.

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.

Time frame: week 6

Data from ClinicalTrials.gov

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