Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

• Status: Terminated
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 treated with an SSRI and experiencing treatment-related sexual dysfunction will experience less sexual dysfunction if they are switched to duloxetine, and 2. they will experience either improved antidepressant response or no loss of antidepressant response.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria::

• 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 Criteria:- 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