Sexual DysfunctionT-SSRI-SDNCT01097980
Trazodone for SSRI-sexual Dsyfunction
A study testing Trazodone in people with Sexual Dysfunction, run by Beitou Armed Forces Hospital, Taipei, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Dysfunction
- What is being tested?
- Trazodone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2010to Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Psychiatry, Beitou Armed Forces Hospital
Taipei, 11243
About this study
Official title: 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.
- Conditions
- Sexual Dysfunction
- Being tested
- Trazodone, Placebo
- Keywords
- trazodone, SSRI, sexual dysfunction, 5-HT2A polymorphism
- Medical subject headings
- Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrazodoneDrug
50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Trazodone | Experimental | Trazodone versus placebo in a randomized, double-blind manner Receives: Drug: Trazodone |
| Placebo | Placebo comparator | Patients received placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beitou Armed Forces Hospital, Taipei, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Kuo-Tung Chiang, Beitou Armed Forces Hospital, Taipei, Taiwan
- Investigators
- Kuo-Tung Chiang, M.D., Study director, Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097980
- Sponsor's protocol ID
- BT098-02
- Other IDs
- CAD-BAFH-M99
- Acronym
- T-SSRI-SD
- Status last verified
- Apr 2012
- First submitted
- 28 Mar 2010
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18978492
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-induced Sexual Dysfunction
- ClinicalTrials.gov ID
- NCT01097980
- Acronym / sponsor ID
- T-SSRI-SD / BT098-02
- Conditions
- Sexual Dysfunction
- Keywords
- trazodone, SSRI, sexual dysfunction, 5-HT2A polymorphism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Beitou Armed Forces Hospital, Taipei, TaiwanOther government
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 2 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trazodone | Experimental | Drug: TrazodoneTrazodone versus placebo in a randomized, double-blind manner |
| Placebo | Placebo comparator | Drug: PlaceboPatients received placebo |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trazodone50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained | Drug | Trazodone |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
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
1 secondary outcome
The association between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were evaluated.
Time frame: week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
- Results publication: PubMed 18978492Stryjer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kuo-Tung Chiang, M.D. study director
Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trazodone in people with Sexual Dysfunction, run by Beitou Armed Forces Hospital, Taipei, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01097980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.