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Unable to recruit subjects
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | 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 |
|
| 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) |
| 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) |
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Inclusion Criteria::
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| Name | Affiliation | Role |
|---|---|---|
| Lorrin M Koran | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine | Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Adult patients taking an antidepressant drug and troubled by sexual side effects of the drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | 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. study duration: 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Four subjects completed the study; two withdrew at end of week six. CGI-I ratings for two subjects were done at end of week 6 and this last observation was carried forward in the analysis. CGI-I ratings for the 4 completing subjects were done at end of week 12. | Posted | Number | participants | baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine | Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) 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 |
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Open label trial, only six subjects enrolled, only 4 completed the trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lorrin Koran, M.D., Professor of Psychiatry, Emeritus | Stanford University Medical Center, Department of Psychiatry | 650 498 5035 | lkoran@stanford.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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|
| Participants |
|
| Age, Continuous | Mean age only. The data were destroyed some years ago, and only the mean age was preserved. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Antidepressant taken prior to duloxetine switch | Number | participants |
|
| Clinically Depressed | Patients with score >22 assessed by Inventory for Depressive Symptomology-Clinician Rated (IDS-C). 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. | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Duloxetine | Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression) 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 |
|
|
| Secondary | 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. | All participants; the last observed non-missing value was used (LOCF) | Posted | Count of Participants | Participants | Last observation (4 subjects at end of week 12, 2 subjects at end of week 6) |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
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| D006571 |
| Heterocyclic Compounds |