NCT02279953已完成3 期
An Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study on the Efficacy of Vortioxetine on Cognitive Dysfunction in Patients With Partial or Full Remission of Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 17
- 主要终点
- Change in Digit Symbol Substitution Test (DSST): number of correct symbols
研究概览
简要总结
To assess the efficacy of vortioxetine (10 to 20 mg/day) as adjunctive treatment to stable selective serotonin reuptake inhibitor (SSRI) dose versus stable SSRI monotherapy on cognitive performance (focusing on the aspect concerning speed of processing, executive functioning and attention) in patients who are in partial or full remission from their Major Depressive Episode (MDE).
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
- Double (Participant, Investigator)
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
- •The patient has achieved either partial (some symptoms of a MDE are present but full criteria are not met) or full remission of major depressive disorder (MDD), diagnosed according to DSM-IV-TR™.
- •The patient has HAMD-17 total score ≤
- •The patient has received SSRI monotherapy for the MDE from which the patient is currently in full or partial remission for ≥12 weeks at licensed doses and been on stable dose ≥8 weeks prior to Screening Visit.
- •The patient has ≥50% response to current SSRI treatment (Antidepressant Treatment Response Questionnaire [ATRQ]).
- •The patient has a PDQ-D total score >
- •The patient is a man or woman, aged ≥18 and ≤65 years.
排除标准
- •The patient has a score ≥70 on the DSST (numbers of correct symbols) at the Baseline Visit.
- •The patient is, in the opinion of the investigator, not able to complete the neuropsychological tests validly at the Baseline Visit.
- •The patient has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
- •The patient is diagnosed with reading disability (dyslexia).
- •The patient has a history of lack of response to previous adequate treatment with vortioxetine.
- •The patient has any current psychiatric disorder or Axis I disorder (according to DSM-IV-TR™ criteria) other than MDD, as assessed using Mini International Neuropsychiatric Interview (MINI).
- •The patient has a current or has had a diagnosis of dysthymic disorder within 3 months preceding the onset of the depressive episode from which the patient is currently in full or partial remission (DSM-IV-TR™ criteria).
- •The patient has borderline, schizotypal, schizoid, paranoid, histrionic, antisocial personality disorders (axis II) as comorbid or primary diagnosis (DSM-IV-TR™ criteria).
- •The patient suffers from personality disorders, mental retardation, pervasive development disorder, attention-deficit/hyperactivity disorder, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
- •The patient has a current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features (DSM-IV-TR™ criteria).
- •Other protocol-defined inclusion and exclusion criteria may apply.
研究组 & 干预措施
SSRI
Experimental
licensed doses, encapsulated, orally
干预措施: SSRI (Drug)
Vortioxetine 10-20 mg + SSRI
Experimental
daily, encapsulated, orally
干预措施: SSRI (Drug)
SSRI
Experimental
licensed doses, encapsulated, orally
干预措施: Placebo (Drug)
Vortioxetine 10-20 mg
Experimental
daily, encapsulated, orally
干预措施: Placebo (Drug)
Vortioxetine 10-20 mg
Experimental
daily, encapsulated, orally
干预措施: Vortioxetine 10-20 mg (Drug)
Vortioxetine 10-20 mg + SSRI
Experimental
daily, encapsulated, orally
干预措施: Vortioxetine 10-20 mg (Drug)
结局指标
主要结局
Change in Digit Symbol Substitution Test (DSST): number of correct symbols
时间窗: Baseline to Week 8
次要结局
- Change in Clinical Global Impression - Severity of Illness (CGI-S)(Baseline to Week 8)
- Clinical Global Impression - Global Improvement (CGI-I) score(Week 8)
- Change in University of San Diego Performance-based Skills Assessment - Brief (UPSA-B) total score(Baseline to Week 8)
- Number of adverse events(Baseline to Week 12)
- Change in Perceived Deficits Questionnaire - Depression (PDQ-D) total score(Baseline to Week 8)
- Change in Hamilton Depression Rating Scale-17 (HAMD-17) total score(Baseline to Week 8)
- Change in Rey Auditory Verbal Learning Test (RAVLT) score: memory (delayed recall) and learning [acquisition])(Baseline to Week 8)
- Change in STROOP: congruent score; speed of processing(Baseline to Week 8)
- Change in reaction time score: Choice Reaction Time (CRT); attention(Baseline to Week 8)
- Change in reaction time score: Simple Reaction Time (SRT); psychomotor speed(Baseline to Week 8)
- Change in Stroop Colour Naming Test (STROOP): incongruent score; executive functioning(Baseline to Week 8)
- Change in TMT score: TMT-B; executive functioning(Baseline to Week 8)
- Change in Trail Making Test (TMT) score: TMT-A; speed of processing(Baseline to Week 8)
- Columbia Suicide Severity Rating Scale (C-SSRS) categorisation based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) definitions (1, 2, 3, 4 and 7)(Baseline to Week 8)
研究者
研究点 (17)
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