Lorrin Koran
Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Duloxetine
Phase:
Phase 4Eligibility
Ages Eligible for Study:
18 years to 65 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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
Key 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
Additional Study Details
Official Title:
Switching to Duloxetine to Ameliorate SSRI-Induced Sexual DysfunctionAnticipated start date:
11/1/2006Lead Sponsor:
Stanford UniversityCollaborator(s):
- Eli Lilly and Company
Investigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
Non-randomizedMasking:
OpenControl:
noneAssignment:
Single GroupEndpoints:
UnspecifiedPrimary Outcomes:
- Arizona Sexual Experience Scale
- Inventory of Depressive Symptomatology, Clinical Rated
- Clinical Global Impressions, Severity and Improvement
Total Number to be Enrolled:
24Total Number to be Enrolled at Stanford:
24More Information
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
1/4/2008PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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