A comparative study to assess the efficacy and safety of Vortioxetine versus Escitalopram in patients suffering from Depressive Disorder.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Vortioxetine will be more efficacious on symptom
研究概览
简要总结
| Major depressive |
| disorder (MDD) is a common mental disorder often associated with deficits in |
| cognitive function. The Diagnostic and Statistical Manual 5 (DSM-5) lists |
| impairment in cognition (i.e. diminished ability to think or concentrate or |
| indecisiveness) as a criterion item in the diagnosis of a major depressive |
| episode (MDE). |
Major depressive disorder (MDD) and generalized anxiety disorder (GAD) are each associated with high rates of sexual dysfunction. One long-term study, for example, estimated that sexual dysfunction was nearly twice as common in people with MDD as in the general population. Pharmacotherapy for MDD or GAD can alleviate sexual dysfunction in some patients, but treatment with most antidepressants is itself associated with some form of sexual dysfunction or worsening sexual dysfunction. As many as 30%–80% of patients treated with selective serotonin reuptake inhibitors (SSRIs) experience some form of treatment-emergent sexual dysfunction (TESD), which can affect any aspect of sexual activity, including desire, arousal, and orgasm. Sexual dysfunction associated with antidepressant use reduces self-esteem and quality of life and burdens interpersonal relationships. It is particularly bothersome to patients and may affect treatment compliance. Escitalopram is a frontline antidepressant. Few studies have examined cognitive and sexual functioning after being treated with antidepressants involving vortioxetine.
We expect vortioxetine to perform better than escitalopram in cognitive and sexual functioning and at least as well as Escitalopram in treating symptoms of depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Both male and female patients aged between 18 and 60 years.
- •Those giving written consent/guardians giving written consent (in cases where the patients were too ill to understand the process of informed consent and give an informed choice.)
- •People diagnosed with the depressive disorder as per ICD-11 diagnostic criteria.
排除标准
- •Systemic or Neurological Disorder affecting Cognition, Behavior or Mental Status.
- •Substance dependence except for Nicotine and Caffeine within the past month of entering the study.
- •Long-standing medical or surgical illnesses.
- •Patients with mental retardation or organic brain disorders.
- •Patients suffering from neurological, metabolic and vascular conditions affecting sexual function.
- •Patients with sexual dysfunction at baseline were excluded from the study.
结局指标
主要结局
Vortioxetine will be more efficacious on symptom
时间窗: At the end of 4 weeks and 8 weeks.
severity in patients suffering from Depression compared to Escitalopram.
时间窗: At the end of 4 weeks and 8 weeks.
次要结局
- Vortioxetine and Escitalopram will have similar(effects on cognitive functioning.)
- Vortioxetine will be safer as compared to(Escitalopram in sexual functioning.)
- Vortioxetine and Escitalopram will have similar side(effects.)
研究者
Jitendriya Biswal
IMS & SUM Hospital