Text Size

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
History of Changes
  Purpose

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 Intervention
Sexual Dysfunction
 Drug: Trazodone
Drug: Placebo

Study Type: Interventional
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
Official Title: The Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-induced Sexual Dysfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beitou Armed Forces Hospital, Taipei, Taiwan:

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. [ Time Frame: week 0 and week 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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.


Enrollment: 56
Study Start Date: April 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097980

Locations
Taiwan
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
  More Information

Publications:

Responsible Party: Kuo-Tung Chiang, Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
ClinicalTrials.gov Identifier: NCT01097980     History of Changes
Other Study ID Numbers: BT098-02, CAD-BAFH-M99
Study First Received: March 28, 2010
Last Updated: April 23, 2012
Health Authority: Taiwan: Department of Health
United States: Food and Drug Administration

Keywords provided by Beitou Armed Forces Hospital, Taipei, Taiwan:
trazodone
SSRI
sexual dysfunction
5-HT2A polymorphism

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Trazodone
Serotonin Uptake Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

ClinicalTrials.gov processed this record on June 18, 2013