Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
This study has been terminated.
(Unable to recruit subjects)
Sponsor:
Stanford University
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depression |
Drug: Duloxetine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Arizona Sexual Experience Scale [ Time Frame: start and last visit ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Inventory of Depressive Symptomology [ Time Frame: start and last visit ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | November 2006 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Duloxetine
Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
|
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
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00398632
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
Eli Lilly and Company
Investigators
| Principal Investigator: | Lorrin M Koran | Stanford University |
More Information
No publications provided
| Responsible Party: | Lorrin M Koran, Professor of Psychiatry, Emeritus, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00398632 History of Changes |
| Other Study ID Numbers: | 97143 |
| Study First Received: | November 10, 2006 |
| Last Updated: | June 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Sexual Dysfunctions, Psychological Behavioral Symptoms Mood Disorders Mental Disorders Sexual and Gender Disorders Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013