Trazodone for SSRI-sexual Dsyfunction (T-SSRI-SD)

Beitou Armed Forces Hospital, Taipei, Taiwan

Status: Completed

Conditions: Sexual Dysfunction

Treatments: Drug: Trazodone; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01097980

CAD-BAFH-M99 (Other Grant/Funding Number)

BT098-02

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

Trazodone

Experimental group

Description:

Trazodone versus placebo in a randomized, double-blind manner

Treatment:

Drug: Trazodone

Placebo

Placebo Comparator group

Description:

Patients received placebo

Treatment:

Drug: Placebo