NCT04294654已完成4 期
Interventional, Open-label Study of Flexible Doses of Vortioxetine on Depressive Symptoms in Patients With Major Depressive Disorder and Early Dementia
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 24
- 主要终点
- Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
研究概览
简要总结
This study evaluates the effectiveness of vortioxetine on depressive symptoms in patients with depression and early dementia
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
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has a primary diagnosis of recurrent Major Depressive Disorder (MDD) with onset before age of 55, diagnosed according to DSM-5®
- •The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
- •The patient has had the current MDE for <6 months.
- •The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score ≥26 at the Baseline Visit.
- •The diagnosis of onset of dementia has occurred at least 6 months prior to screening and after already being diagnosed with MDD. The diagnosis of dementia must be documented in patient's medical records. When deemed necessary per investigator judgement of patient clinical status and early dementia, the patient must be accompanied by a caregiver to study visits.
- •Patients with dementia associated with vitamin B12 or folate deficiency should not be enrolled.
- •Patients with or without treatment for dementia can be enrolled. For patients on treatment for dementia, there must be no change in treatment during the study and patients must be on stable dose for at least 3 months prior to the Screening Visit.
- •The patient has Mini Mental State Examination (MMSE) total score 20-24, inclusive.
排除标准
- •The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.
- •Other in- and exclusion criteria may apply
研究组 & 干预措施
Vortioxetine
Experimental
5 - 20 mg/day tablets
干预措施: Vortioxetine (Drug)
结局指标
主要结局
Change in Montgomery and Åsberg Depression Rating Scale (MADRS) total score
时间窗: from baseline to Week 12
The Montgomery and Åsberg Depression Rating Scale (MADRS) is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). The total score of the 10 items ranges from 0 to 60, with higher values indicating worse outcome.
次要结局
- Remission defined by MADRS score(at Week 12)
- Response defined by decrease in MADRS total score(At Week 12)
- Change in Digit-Symbol Substitution Test (DSST) Substitution Test (DSST) score(from baseline to Week 12)
- Change in Rey Auditory Verbal Learning Test (RAVLT) score(from baseline to Week 12)
- Change in Instrumental Activities of Daily Living (IADL) score(from baseline to Week 12)
- Clinical Global Impression - Improvement (CGI-I) score(at Week 12)
- Change in Clinical Global Impression - Severity (CGI-S) score(from baseline to Week 12)
- Change in Bath Assessment of Subjective Quality of Life in Dementia (BASQID) score(from baseline to Week 12)
研究者
研究点 (24)
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