T-SSRI-SD: Trazodone for SSRI-sexual Dsyfunction

Sponsor

Beitou Armed Forces Hospital, Taipei, Taiwan (Other)

Overall Status

Completed

CT.gov ID

NCT01097980

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Sexual Dysfunction	Drug: Trazodone Drug: Placebo	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2010

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Trazodone

Trazodone versus placebo in a randomized, double-blind manner

Drug: Trazodone

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

Placebo Comparator: Placebo

Patients received placebo

Drug: Placebo

Placebo

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Psychiatry, Beitou Armed Forces Hospital	Taipei		Taiwan	11243

Sponsors and Collaborators

Beitou Armed Forces Hospital, Taipei, Taiwan

Investigators

Study Director: Kuo-Tung Chiang, M.D., Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Kuo-Tung Chiang, Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan

ClinicalTrials.gov Identifier:

NCT01097980

Other Study ID Numbers:

BT098-02
CAD-BAFH-M99

First Posted:

Apr 2, 2010

Last Update Posted:

Apr 24, 2012

Last Verified:

Apr 1, 2012

Keywords provided by Kuo-Tung Chiang, Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan

Additional relevant MeSH terms:

Trazodone

Study Results

No Results Posted as of Apr 24, 2012