Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

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Primary Purpose

Status

Terminated

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Duloxetine

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Stanford University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00398632

First Posted

November 10, 2006

Last Updated

October 15, 2017

Sponsor

Stanford University

Collaborators

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00398632

Brief Title

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Official Title

Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Terminated

Why Stopped

Unable to recruit subjects

Study Start Date

November 2006 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duloxetine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Duloxetine

Other Intervention Name(s)

Cymbalta

Intervention Description

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

Primary Outcome Measure Information:

Title

Global Clinical Impressions Improvement Score re Sexual Functioning

Description

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.

Time Frame

baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)

Secondary Outcome Measure Information:

Title

Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study

Description

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.

Time Frame

Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorrin M Koran

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University School of Medicine

City

Stanford

State/Province

California

ZIP/Postal Code

94305

Country

United States

Depression

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial