Trazodone for SSRI-sexual Dsyfunction

NCT01097980 | Completed DMC

• 2 other identifiers: BT098-02CAD-BAFH-M99
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Sexual Dysfunction

Keywords

trazodone; SSRI; sexual dysfunction; 5-HT2A polymorphism

Outcome Measures

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.

  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.

  week 6

Study Arms (2)

Trazodone

EXPERIMENTAL

Trazodone versus placebo in a randomized, double-blind manner

Drug: Trazodone

Placebo

PLACEBO COMPARATOR

Patients received placebo

Drug: Placebo

Interventions

Trazodone DRUG

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

Trazodone

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beitou Armed Forces Hospital, Taipei, Taiwan: lead

Study Sites (1)

Department of Psychiatry, Beitou Armed Forces Hospital

Taipei, 11243, Taiwan

Location

Related 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):82-4. doi: 10.1097/WNF.0B013E31816D1CDC.

  PMID: 18978492 RESULT

MeSH Terms

Conditions

Sexual Dysfunction, Physiological

Interventions

Trazodone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridones; Pyridines

Study Officials

• Kuo-Tung Chiang, M.D.

  Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Psychiatry

Study Record Dates

• First Submitted: March 28, 2010
• First Posted: April 2, 2010
• Study Start: April 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: April 24, 2012

Record last verified: 2012-04

Locations

TW (1)