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Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

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ClinicalTrials.gov Identifier: NCT00398632
Recruitment Status : Terminated (Unable to recruit subjects)
First Posted : November 14, 2006
Results First Posted : June 16, 2015
Last Update Posted : November 17, 2017
Eli Lilly and Company
Information provided by (Responsible Party):
Lorrin M Koran, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Drug: Duloxetine Phase 4

Detailed 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
Study Start Date : November 2006
Primary Completion Date : April 2009
Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Global Clinical Impressions Improvement Score re Sexual Functioning [ Time Frame: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6) ]
    The GCI-I score is a global clinical impression score regarding a patient's symptom severity change rated by the treating clinician. The score can be 0 (not assessed), 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse) or 7 (very much worse). In this study clinicians made ratings based on interviewing the patient and reviewing the patient's self ratings on the the Arizona Sexual Experiences Scale (ASEX). No formal cut point scores on the ASEX were established. The ASEX is a 5-item slef rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach organism, and satisfaction from orgasm. Each item is rated from 1 to 6 (total scores from 5 to 30), with higher scores indicating greater sexual dysfunction.

Secondary Outcome Measures :
  1. Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study [ Time Frame: Last observation (4 subjects at end of week 12, 2 subjects at end of week 6) ]
    The IDS-C is a 30-item inventory designed to assess the severity of depressive symptoms. Scale range minimum = 0 / maximum = 84. Higher values are considered to be worse outcomes. Scores less than or equal to 6 indicated remission in this study.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00398632

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

Responsible Party: Lorrin M Koran, Professor of Psychiatry, Emeritus, Stanford University
ClinicalTrials.gov Identifier: NCT00398632     History of Changes
Other Study ID Numbers: 97143
First Posted: November 14, 2006    Key Record Dates
Results First Posted: June 16, 2015
Last Update Posted: November 17, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents