EUCTR2014-000229-19-EE进行中（未招募）1 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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 195
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
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 =10.
- •- 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 >25.
- •- The patient is a man or woman, aged =18 and =65 years.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 185
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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).
研究者
相似试验
进行中（未招募）
1 期
A study to evaluate the cognitive effect of a product named vortioxetine (used in depression). These effects willbe compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.EUCTR2014-000229-19-FIH. Lundbeck A/S195
进行中（未招募）
1 期
Efficacy of KL1333 in adult patients with primary mitochondrial diseaseAdult patients with primary mitochondrial diseaseMedDRA version: 20.0Level: HLTClassification code 10052637Term: Genetic mitochondrial abnormalities NECSystem Organ Class: 100000004850EUCTR2021-002846-33-DKAbliva AB180
进行中（未招募）
不适用
A study to evaluate the cognitive effect of a product named vortioxetine (used in in depression). These effects will be compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.EUCTR2014-000230-34-LTH. Lundbeck A/S195
进行中（未招募）
不适用
A study to evaluate the cognitive effect of a product named vortioxetine (used in depression) for patient with inadequate effect of other drugs for depression. These effects will be compared to those induced by a marketed comparator. Investigator and subjects will be blinded.Major Depressive Disorder and cognitive impairmentMedDRA version: 17.1Level: PTClassification code 10057840Term: Major depressionSystem Organ Class: 10037175 - Psychiatric disordersEUCTR2014-000231-16-DEH. Lundbeck A/S130
进行中（未招募）
不适用
A study to evaluate the cognitive effect of a product named vortioxetine (used in in depression). These effects will be compared to those induced by a marketed comparator and a placebo. Investigator and subjects will be blinded.EUCTR2014-000230-34-SKH. Lundbeck A/S195