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Completed

NCT Number: NCT01097980

Trazodone for SSRI-sexual Dsyfunction

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.

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Key information

Conditions

Sexual Dysfunction Genital Diseases Sexual Dysfunction, Physiological Urogenital Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry, Beitou Armed Forces Hospital

Taipei, 11243, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Trazodone

Drug

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

Placebo

Drug

Placebo

Primary outcomes

  1. 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

  1. The association between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were evaluated.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beitou Armed Forces Hospital, Taipei, Taiwan

Other Gov

Registry information

Official study title

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

Acronym: T-SSRI-SD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2010
Registry last updated
Apr 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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