EUCTR2011-005298-22-FI进行中（未招募）不适用
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Flexible Dose Study on the Efficacy of Lu AA21004 on Cognitive Dysfunction in Adult Subjects with Major Depressive Disorder (MDD)
Takeda Global Research & Development Centre (Europe) Ltd0 个研究点目标入组 600 人开始时间: 2012年5月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
- •1. The subject has recurrent MDD as the primary diagnosis according to DSM-IV-TR criteria (classification code 296.3x). The current major depressive episode (MDE) should be confirmed using the Mini International Neuropsychiatric Interview (MINI V6.0.0).
- •2. The subject has received prescribed treatment for a previous episode of depression.
- •3. The subject has a Montgomery-Åsberg Depression Rating Scale
- •(MADRS) total score =26 at both screening and
- •4. Subject reports subjective cognitive dysfunction (such as difficulty concentrating, slow thinking, and difficulty in learning new things or remembering things).
- •5. The reported duration of the current MDE is at least 3 months.
- •6. The subject is a man or woman between 18 and 65 years old, inclusive.
- •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 587
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1. The subject has a score =70 on the Digit Symbol Substitution Test (DSST) (numbers correct) at the Baseline Visit.
- •2. The subject has 1 or more of the following:
- •– Any current psychiatric disorder other than MDD as defined in the DSM-IV-TR (as assessed by the MINI, Version 6.0.0).
- •– Current or history of attention deficit hyperactivity disorder (ADHD), pervasive developmental disorder, manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
- •– Current diagnosis of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV-TR that has not been in sustained full remission for at least 2 years prior to Screening. (Subject must also have negative urine drug screen prior to Baseline.)
- •– Presence or history of a clinically significant neurological disorder (including epilepsy).
- •– Neurodegenerative disorder (Alzheimer Disease, Parkinson Disease, multiple sclerosis, Huntington Disease, etc).
- •– Any DSM-IV Axis II disorder that might compromise the study.
- •3. The subject has any other disorder for which the treatment takes priority over treatment of MDD or is likely to interfere with study treatment or impair treatment compliance.
- •4. The subject has physical, cognitive, or language impairment of such severity as to adversely affect the validity of the data derived from the neuropsychological tests.
- •5. The subject has a significant risk of suicide according to the investigator’s clinical judgment or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 6 months.
- •6. The subject, in the opinion of the investigator, poses a risk of harm to others.
- •7. The subject has initiated formal cognitive or behavioral therapy, systemic psychotherapy within less than 6 months of study screening, or has plans to initiate such therapy during the study.
- •8. The subject has received electroconvulsive therapy, vagal nerve stimulation, or repetitive transcranial magnetic stimulation within 6 months prior to Screening.
- •9. The current depressive symptoms are considered by the investigator to have been resistant to 2 adequate antidepressant treatments of at least 6 weeks duration each at the recommended dose.
- •10. The subject has a history of lack of response to previous adequate treatment with duloxetine.
- •11. The subject has a clinically significant unstable illness, for example, hepatic impairment or renal insufficiency, or cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, rheumatologic, immunologic, infectious, skin and subcutaneous tissue disorders, or metabolic disturbance.
- •Note: For the purposes of this protocol, the following conditions are considered unstable due to the potential impact on assessment of MDD response and/or cognitive status: pain disorders, chronic fatigue syndrome, fibromyalgia, obstructive sleep apnea, and known cases of HIV, HBV, and HCV.
- •12. The subject has thyroid stimulating hormone (TSH) outside the
- •normal range at the Screening Visit.
- •Note: If TSH value is outside the normal range, a free T4 will be
- •obtained. Subjects who have elevated TSH but normal T4 (i.e. subclinical
- •hypothyroidism) will be excluded. For subjects who are on thyroid
- •hormone replacement therapy, a lower TSH with
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