Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Depression Clinical Trial

Official title:

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00398632
• Other study ID #: 97143
• Status: Terminated
• Phase: Phase 4
• First received: November 10, 2006
• Last updated: October 15, 2017
• Start date: November 2006
• Est. completion date: April 2009

Study information

• Verified date: October 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

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

Related Conditions & MeSH terms

• Depression

Intervention

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

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global Clinical Impressions Improvement Score re Sexual Functioning	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.	baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)
Secondary	Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study	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.	Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)