Trazodone for SSRI-sexual Dsyfunction

NCT ID: NCT01097980

Last Updated: 2012-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sexual Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Trazodone

Trazodone versus placebo in a randomized, double-blind manner

Group Type EXPERIMENTAL

Trazodone

Intervention Type DRUG

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

Placebo

Patients received placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Trazodone

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

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beitou Armed Forces Hospital, Taipei, Taiwan

OTHER_GOV

Sponsor Role lead

Responsible Party

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Kuo-Tung Chiang

Department of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kuo-Tung Chiang, M.D.

Role: STUDY_DIRECTOR

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

Locations

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Department of Psychiatry, Beitou Armed Forces Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type RESULT
PMID: 18978492 (View on PubMed)

Other Identifiers

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CAD-BAFH-M99

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BT098-02

Identifier Type: -

Identifier Source: org_study_id

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