Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

This study has been terminated.
(Unable to recruit subjects)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University
ClinicalTrials.gov Identifier:
NCT00398632
First received: November 10, 2006
Last updated: June 5, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Depression
Drug: Duloxetine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Arizona Sexual Experience Scale [ Time Frame: start and last visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inventory of Depressive Symptomology [ Time Frame: start and last visit ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: November 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Duloxetine
Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398632

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Eli Lilly and Company
Investigators
Principal Investigator: Lorrin M Koran Stanford University
  More Information

No publications provided

Responsible Party: Lorrin M Koran, Professor of Psychiatry, Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00398632     History of Changes
Other Study ID Numbers: 97143
Study First Received: November 10, 2006
Last Updated: June 5, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Depression
Behavioral Symptoms
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014