EUCTR2007-004992-21-EE进行中（未招募）不适用
A long-term, open-label, flexible-dose, extension study evaluating the safety and tolerability of Lu AA21004 in patients with Major Depressive Disorder - Not applicable
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 550
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
- •A patient who meets all the following criteria, is eligible for inclusion in this study:
- •1.The patient is able to read and understand the Subject Information Sheet for the present study, different from the one for study 11984A.
- •2.The patient has signed the new Informed Consent Form, which is separate from the signed informed consent obtained for the study 11984A.
- •3.The patient must have completed study 11984A (Visit 7: Week 8) immediately prior to enrolment into the extension study.
- •4.The patient had a documented primary diagnosis of a Major Depressive Episode (MDE) at entry in study 11984A.
- •5.The patient, if female, must:
- •-agree not to try to become pregnant during the study, AND
- •-use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR
- •-have had her last natural menstruation at least 24 months prior to baseline, OR
- •-have been surgically sterilised prior to baseline, OR
- •-have had a hysterectomy prior to baseline, OR
- •-not be sexually active with men
- •6.The patient is indicated 12-month continuation treatment with Lu AA21004 according to the clinical opinion of the investigator.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •In addition to the exclusion criteria applying for study 11984A (appendix V), and which are met at baseline visit, except criteria:
- •-7 (increased intra-ocular pressure or at risk of acute narrow-angle glaucoma
- •-9 (chronic liver disease)
- •-11 (history of lack of response to previous adequate treatment with duloxetine)
- •-17 (previous exposure to investigational drug)
- •-22 (previous exposure to Lu AA21004)
- •Patients who meet one or more of the following criteria are not eligible for inclusion in this study:
- •1.The patient with Major Depressive Disorder, for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia or any psychotic disorder) have been diagnosed during study 11984A.
- •2.The patient, in the investigator’s opinion has a significant risk of suicide, and/or a score of 5 points or higher on item 10 (suicidal thoughts) of the MADRS.
- •3.The patient is in the opinion of the investigator, unlikely to be able to comply with the clinical trial protocol or is unsuitable for any other reasons.
- •4.The patient has a clinically significant, moderate or severe ongoing adverse event, related to study medication in study 11984A.
- •5.The patient has used/ uses disallowed recent or concomitant medication (specified in Appendix II, Recent and Concomitant medication).
研究者
相似试验
进行中（未招募）
不适用
The study is measuring how well patients with Major Depressive Disorder tolerate long treatment with the study drug Lu AA21004. Patients will know which dose of Lu AA21004 is given 15 or 20 mg/day.Major Depressive DisorderEUCTR2010-024198-38-LVH. Lundbeck A/S300
进行中（未招募）
不适用
A long-term, open-label, flexible-dose, extension study evaluating the safety and tolerability of Lu AA21004 in patients with Major Depressive Disorder - Not applicableMedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSMajor Depressive DisorderEUCTR2007-004992-21-BGH. Lundbeck A/S550
进行中（未招募）
不适用
A long-term, open-label, flexible-dose, extension study evaluating the safety and tolerability of Lu AA21004 in patients with Major Depressive Disorder - Not applicableMedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSMajor Depressive DisorderEUCTR2007-004992-21-FIH. Lundbeck A/S550
进行中（未招募）
不适用
A long-term, open-label, flexible-dose, extension study evaluating the safety and tolerability of Lu AA21004 (15 and 20 mg/day) in patients with Major Depressive Disorder - NAMedDRA version: 12.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSMedDRA version: 12.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeMajor Depressive DisorderEUCTR2010-024198-38-FIH. Lundbeck A/S300
进行中（未招募）
不适用
A long-term, open-label, flexible-dose, extension study evaluating the safety and tolerability of Lu AA21004 in patients with Major Depressive Disorder - Not applicableMedDRA version: 9.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSMajor Depressive DisorderEUCTR2007-004992-21-LVH. Lundbeck A/S550