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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

Page last updated: August 23, 2015

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