Status:
TERMINATED
Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
Lead Sponsor:
Stanford University
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs). The hypotheses of this study are that:1. subjects with major depression or dysthymia who are being treate...
Detailed Description
In this study, subjects suffering from depression or dysthymia and experiencing treatment-emergent sexual dysfunction from an SSRI are switched from their SSRI to duloxetine to determine whether or no...
Eligibility Criteria
Inclusion
- :
- age 18 - 65 inclusive
- able to read and understand informed consent
- informed consent given
- currently being treated with an SSRI for depression or dysthymia
- currently suffering from treatment-emergent sexual dysfunction attributable to the SSRI
- have normal safety lab values at screen
- if currently taking medication to improve sexual performance, willing to discontinue the drug for the duration of the study
- female subjects of child bearing age need to use an acceptable form of birth control throughout the study
Exclusion
- being pregnant, breastfeeding, or planning to become pregnant within 4 months
- suffering from psychotic, substance abuse, bipolar, or organic mental disorder, OCD, panic disorder, or personality disorder severe enough to interfere with study participation
- suffer from an unstable or serious medical disorder
- having a medical disorder that could be the cause of the sexual dysfunction
- taking a medication that is metabolized by hepatic enzyme CYP2D6
- having used a MAOI within 15 days of proposed start of duloxetine treatment
- having a known hypersensitivity to duloxetine or any of its ingredients
- having taken viagra or related drug within 3 months prior to starting SSRI treatment
- requiring ongoing treatment with a mood stabilizer (anticonvulsant) or antipsychotic medication
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00398632
Start Date
November 1 2006
End Date
April 1 2009
Last Update
November 17 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305