Trazodone for SSRI-sexual Dsyfunction

Sexual Dysfunction Clinical Trial

— T-SSRI-SD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097980
• Other study ID #: BT098-02
• Secondary ID: CAD-BAFH-M99
• Status: Completed
• Phase: N/A
• First received: March 28, 2010
• Last updated: April 23, 2012
• Start date: April 2010
• Est. completion date: January 2012

Study information

• Verified date: April 2012
• Source: Beitou Armed Forces Hospital, Taipei, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

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

Related Conditions & MeSH terms

• Sexual Dysfunction

Intervention

Drug:
• Trazodone
50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained
• Placebo
Placebo

Locations

Country	Name	City	State
Taiwan	Department of Psychiatry, Beitou Armed Forces Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Beitou Armed Forces Hospital, Taipei, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (1)

Stryjer R, Spivak B, Strous RD, Shiloh R, Harary E, Polak L, Birgen M, Kotler M, Weizman A. Trazodone for the treatment of sexual dysfunction induced by serotonin reuptake inhibitors: a preliminary open-label study. Clin Neuropharmacol. 2009 Mar-Apr;32(2) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes