Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Study Overview
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Brief Summary
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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
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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

Official Title
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Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Conditions
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Depression

Intervention / Treatment
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* Drug: Duloxetine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Duloxetine<br>Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) | Drug: Duloxetine<br>* 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<br>* Other names: Cymbalta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |