An Open-label, Long-Term Extension Study to Assess the Safety and Efficacy of Lu AA21004 in Patients with Major Depressive Disorder

Takeda Pharmaceutical Company Limited0 个研究点目标入组 100 人开始时间: 2011年6月27日最近更新: 2023年10月17日

试验速览

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•1.The subject has completed the double-blind treatment period of the preceding study (CCT-003)
•2.The subject signs and dates a written, informed consent form for this study, different from that for the preceding study (CCT-003).
•3.The subject has CGI-S score improved at least one point at completion of the 8-week double-blind treatment period compared to the Baseline Visit in the preceding study (CCT-003).
•4.In the opinion of the investigator, the subject appears to benefit from long-term treatment of Lu AA21004.

•1.The subject was diagnosed with the following disorder or symptom in the preceding study (CCT-003):
•-Any current psychiatric disorder other than MDD as defined in a Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR).
•-Any substance-related disorder (except nicotine and caffeine-related disorders) as defined in the DSM-IV-TR.
•-Clinically significant neurological disorder (including epilepsy).
•-Neurodegenerative disorder (Alzheimer's disease, Parkinson's disease, multiple sclerosis, Huntington's disease, etc.).
•-Any DSM-IV-TR axis II disorder that might compromise this study.
•2.The subject is at significant risk of suicide, or had a score >=5 on Item 10 (suicidal thoughts) of the MADRS or attempted suicides during the preceding study (CCT-003)

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