Depression
Conditions
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
Interventions
DRUGDuloxetine
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
Sponsors
Eli Lilly and Company
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Clinical Impressions Improvement Score re Sexual Functioning | baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6) | 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
| Measure | Time frame | Description |
|---|---|---|
| Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study | Last observation (4 subjects at end of week 12, 2 subjects at end of week 6) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lack of Efficacy | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Duloxetine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 44 years |
| Antidepressant taken prior to duloxetine switch citalopram | 2 participants |
| Antidepressant taken prior to duloxetine switch fluoxetine | 1 participants |
| Antidepressant taken prior to duloxetine switch venlafaxine | 3 participants |
| Clinically Depressed | 2 Participants |
| Region of Enrollment United States | 6 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.
Time frame: baseline and last observation (4 subjects at end of week 12, 2 subjects at end of week 6)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Duloxetine | Global Clinical Impressions Improvement Score re Sexual Functioning | CGI sexual functioning much improved | 1 participants |
| Duloxetine | Global Clinical Impressions Improvement Score re Sexual Functioning | CGI sexual functioning minimally improved | 3 participants |
| Duloxetine | Global Clinical Impressions Improvement Score re Sexual Functioning | CGi-I sexual functioning unchanged | 1 participants |
| Duloxetine | Global Clinical Impressions Improvement Score re Sexual Functioning | CGI sexual functioning much worse | 1 participants |
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.
Time frame: Last observation (4 subjects at end of week 12, 2 subjects at end of week 6)
Population: All participants; the last observed non-missing value was used (LOCF)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duloxetine | Count of Patients With Remission of Depressive Symptoms According to the Inventory for Depressive Symptomology-Clinician Rated (IDS-C) at End of Study | 5 Participants |