Vortioxetine as a Novel Anti-depressant With Improvement in Cognitive Abilities - a Randomized Controlled Parallel Assigned Study
试验速览
- 阶段
- 3 期
- 入组人数
- 500
- 主要终点
- Montgomery-Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
To the best of the knowledge of the Principal Investigators, there was no randomised controlled trial to assess the potential cognitive improvement seen with Vortioxetine, in comparison with some other most commonly used SNRI, when used as directed for the treatment of Major Depressive Disorders. As such the outcome of this trial will provide evidence to assess this claim in the Pakistani population and determine the clinical efficacy when compared to some other commonly used anti-depressants. This would be the first randomized trial dedicated for this assessment in the region with an active control of one of the most commonly used Selective Serotonin and Norepinephrine Reuptake Inhibitors (SSNRIs) in Pakistan for the treatment of depression, Venlafaxine. It can be utilized as an alternative to MDD treatment options, especially where the focus is on improving the cognitive abilities of the patients.
详细描述
What is Known?
Major Depressive Disorder (MDD) is a distressing and highly prevalent condition which affects the individual's physical, emotional and cognitive well-being, making it one of the leading causes of disability worldwide.
Rationale:
Among the other symptoms, cognitive dysfunctions are one of the major impacts of this disorder and sometimes even overshadow the depressive symptoms2. Disturbances in cognitive functions affect a person's performance in life and work, affecting their concentration, focus, memory, planning, and decision making. Moreover, lack of sleep and dominant-negative thoughts associated with depression also make the cognitive ability worse.
Literature review has consistently demonstrated the negative impact on cognitive abilities affecting the productivity and functioning of individuals with MDD, despite the wide variety of study designs or locations. Cognitive dysfunctions is one of the most common effects reported throughout these studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The participant would be randomly allocated to either of the two interventional groups
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 years
- •Diagnosis of recurrent MDD* > 3 months
- •>26 score of MADRS
- •Participant is a permanent resident of Rawalpindi/Islamabad so that follow up is easy
排除标准
- •Age <18 or >65 years
- •Presence of any other psychiatric disorders (other than MDD)
- •Presence of any organic causes of depression like drug abuse, hypothyroidism, anemia, Cushing syndrome) (Attach reports**)
- •Any physical, cognitive or language disability to perform the cognitive tests
- •Risk of suicide
- •Resistant to previous treatments with either of the interventions (Vortioxetine or Venlafaxine)
- •DSST score >70 at baseline visit
- •According to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) ** Lab tests:
- •Urine drug test for drug abuse
- •Serum TSH to exclude Hypothyroidism
- •Serum Hb to exclude Anaemia
- •Serum Cortisol to exclude Cushing syndrome
研究组 & 干预措施
Vorscot Arm
Vortioxetine 10 mg
干预措施: Vortioxetine (Drug)
Vanlafexine Arm
Venlafaxine 75 mg
干预措施: Venlafaxine (Drug)
结局指标
主要结局
Montgomery-Asberg Depression Rating Scale (MADRS)
时间窗: 8 weeks
The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates "mild depression," 20 to 34 indicates "moderate depression," a score of 35 and greater indicates "severe depression," and a total score of 60 or greater indicates "very severe depression."57 There is evidence that an improvement of two points or more on the MADRS is considered clinically relevant.
次要结局
- Mini Mental State Examination (MMSE Score)(8 weeks)
- Montreal congnitive score(8 weeks)
- Clinical Global Impression (CGI)(8 weeks)
- Digit symbol substitution test (DSST)(8 weeks)