Switching to Duloxetine to Ameliorate SSRI-Induced Sexual Dysfunction
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Global Clinical Impressions Improvement Score re Sexual Functioning
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Duloxetine
Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)
干预措施: Duloxetine (Drug)
结局指标
主要结局
Global Clinical Impressions Improvement Score re Sexual Functioning
时间窗: 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.
次要结局
- 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))
研究者
Lorrin M Koran
Professor of Psychiatry, Emeritus
Stanford University