Trazodone for SSRI-sexual Dsyfunction (T-SSRI-SD)
This study has been completed.
Information provided by (Responsible Party):
Kuo-Tung Chiang, Beitou Armed Forces Hospital, Taipei, Taiwan
First received: March 28, 2010
Last updated: April 23, 2012
Last verified: April 2012
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.
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
||The Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-induced Sexual Dysfunction
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.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||January 2012 (Final data collection date for primary outcome measure)
Trazodone versus placebo in a randomized, double-blind manner
50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained
Placebo Comparator: Placebo
Patients received placebo
|Ages Eligible for Study:
||20 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01097980
|Department of Psychiatry, Beitou Armed Forces Hospital
|Taipei, Taiwan, 11243 |
Beitou Armed Forces Hospital, Taipei, Taiwan
||Kuo-Tung Chiang, M.D.
||Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
||Kuo-Tung Chiang, Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
History of Changes
|Other Study ID Numbers:
|Study First Received:
||March 28, 2010
||April 23, 2012
||Taiwan: Department of Health
United States: Food and Drug Administration
Keywords provided by Beitou Armed Forces Hospital, Taipei, Taiwan:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 03, 2015
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Serotonin Uptake Inhibitors