EUCTR2008-001581-91-LT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 Subjects With Major Depressive Disorder
Takeda Global Research & Development Centre (Europe) Ltd.0 个研究点目标入组 840 人开始时间: 2008年7月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 840
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
- •Subject eligibility is determined according to the following criteria:
- •1. The subject has completed the double blind treatment period of either study Lu AA21004_304 or Lu AA21004_305 immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
- •2. The subject suffers from a MDE as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.xx) at entry into the prior Lu AA21004_304 or Lu AA21004_305 study.
- •3. The subject is capable of understanding and complying with protocol requirements.
- •4. Twelve-month continuation treatment with Lu AA21004 is indicated for the treatment of this subject according to the opinion of the investigator.
- •5. A male subject, or a female subject of childbearing potential, who is sexually active agrees to use adequate contraception from Screening throughout the duration of the study and for 1 month after the last dose of study medication. Women NOT of child bearing potential are defined as those who have been surgically sterilized (documented hysterectomy, bilateral oophorectomy, or tubal ligation) or who are postmenopausal (defined as at least 2 years since last menses). Acceptable methods of contraception are defined in the Contraception and Pregnancy Avoidance Procedure section of the protocol.
- •6. The subject has signed the Informed Consent Form. No study-related procedures may be performed before the subject has signed the form.
- •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 meeting the exclusion criteria for studies Lu AA21004_304 or Lu AA21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:
- •1. The subject with MDD for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
- •2. The subject, in the investigator’s opinion, has a significant risk of suicide and/or a score of =5 points on item 10 (suicidal thoughts) of the MADRS.
- •3. The subject, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
- •4. The patient has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
- •5. The subject has used/uses disallowed concomitant medication.
研究者
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