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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kuo-Tung Chiang, Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier:
NCT01097980
First received: March 28, 2010
Last updated: April 23, 2012
Last verified: April 2012

March 28, 2010
April 23, 2012
April 2010
January 2012   (final data collection date for primary outcome measure)
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. [ Time Frame: week 0 and week 6 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01097980 on ClinicalTrials.gov Archive Site
The association between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were evaluated. [ Time Frame: week 6 ] [ Designated as safety issue: Yes ]
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.
Same as current
Not Provided
Not Provided
 
Trazodone for SSRI-sexual Dsyfunction
The Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-induced Sexual Dysfunction

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Sexual Dysfunction
  • Drug: Trazodone
    50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained
  • Drug: Placebo
    Placebo
  • Experimental: Trazodone
    Trazodone versus placebo in a randomized, double-blind manner
    Intervention: Drug: Trazodone
  • Placebo Comparator: Placebo
    Patients received placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
January 2012
January 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT01097980
BT098-02, CAD-BAFH-M99
Yes
Kuo-Tung Chiang, Beitou Armed Forces Hospital, Taipei, Taiwan
Beitou Armed Forces Hospital, Taipei, Taiwan
Not Provided
Study Director: Kuo-Tung Chiang, M.D. Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
Beitou Armed Forces Hospital, Taipei, Taiwan
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP