Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Stanford University

Status and phase

Terminated

Phase 4

Conditions

Depression

Treatments

Drug: Duloxetine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00398632

97143

Details and patient eligibility

About

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.

Full 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 not they experience improved sexual function and equal or improved antidepressant response. Study subjects are assigned to receive open label duloxetine for 12 weeks at either 60mg per day or 120mg per day after discontinuing their current antidepressant

Enrollment

6 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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