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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 10, 2006

Last Updated Date

June 5, 2012

Start Date ^ICMJE

November 2006

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Arizona Sexual Experience Scale
Inventory of Depressive Symptomatology, Clinical Rated
Clinical Global Impressions, Severity and Improvement

Change History

Complete list of historical versions of study NCT00398632 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Official Title ^ICMJE

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Brief Summary

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Depression

Intervention ^ICMJE

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

Study Arm (s)

Experimental: Duloxetine

Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)

Intervention: Drug: Duloxetine

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00398632

Other Study ID Numbers ^ICMJE

97143

Has Data Monitoring Committee

Responsible Party

Lorrin M Koran, Stanford University

Study Sponsor ^ICMJE

Stanford University

Collaborators ^ICMJE

Eli Lilly and Company

Investigators ^ICMJE

Principal Investigator:

Lorrin M Koran

Stanford University

Information Provided By

Stanford University

Verification Date

June 2012

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

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