ong-Term Extension Study of Lu AA21004 in Participants with Major Depressive Disorder
- Conditions
- Major depressive disorder
- Registration Number
- JPRN-jRCT2080221491
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method