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Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

NCT ID: NCT00398632

Last Updated: 2017-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-04-30

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

Conditions

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Depression

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Duloxetine

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

Group Type EXPERIMENTAL

Duloxetine

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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Cymbalta

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Lorrin M Koran

Professor of Psychiatry, Emeritus

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lorrin M Koran

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University School of Medicine

Stanford, California, United States

Site Status

Countries

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United States

Other Identifiers

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97143

Identifier Type: -

Identifier Source: org_study_id