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Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

This study has been terminated.
(Unable to recruit subjects)
Eli Lilly and Company
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University Identifier:
First received: November 10, 2006
Last updated: June 5, 2012
Last verified: June 2012

November 10, 2006
June 5, 2012
November 2006
April 2009   (final data collection date for primary outcome measure)
Arizona Sexual Experience Scale [ Time Frame: start and last visit ] [ Designated as safety issue: No ]
  • Arizona Sexual Experience Scale
  • Inventory of Depressive Symptomatology, Clinical Rated
  • Clinical Global Impressions, Severity and Improvement
Complete list of historical versions of study NCT00398632 on Archive Site
Inventory of Depressive Symptomology [ Time Frame: start and last visit ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Sexual dysfunction is a common side effect of selective serotonin reuptake inhibitors (SSRIs). The hypothesis of this study is that 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 that they will experience either improved antidepressant response or no loss of antidepressant response.

In this study, 24 subjects suffering from depression or dysthymia and experiencing treatment-emergent sexual dysfunction from an SSRI will be switched from their SSRI to duloxetine to determine whether or not they will experience improved sexual function and equal or improved antidepressant response. All study subjects will receive duloxetine for 12 weeks at either 60mg per day or 120mg per day.

Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Drug: Duloxetine
dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks
Other Name: Cymbalta
Experimental: Duloxetine
Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
Intervention: Drug: Duloxetine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2009
April 2009   (final data collection date for primary outcome measure)

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
18 Years to 65 Years
Contact information is only displayed when the study is recruiting subjects
United States
Lorrin M Koran, Stanford University
Stanford University
Eli Lilly and Company
Principal Investigator: Lorrin M Koran Stanford University
Stanford University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP