Clinical trial NCT00398632: Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
Official title: Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Depression
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2006-11-14
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Eligibility 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

Primary outcomes:
measure: Global Clinical Impressions Improvement Score re Sexual Functioning
timeFrame: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)
Secondary outcomes:
measure: Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study
timeFrame: Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Lorrin M Koran
role: PRINCIPAL_INVESTIGATOR
References: