Trial Search Results

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Stanford University

Collaborator: Eli Lilly and Company

Stanford Investigator(s):

Intervention(s):

  • Drug: Duloxetine

Phase:

Phase 4

Eligibility


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

Ages Eligible for Study

18 Years - 65 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nona Gamel
6507255180