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Clinical Trials/JPRN-jRCT2080221491
JPRN-jRCT2080221491
Unknown
Phase 3

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 sites100 target enrollmentJune 27, 2011
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Takeda Pharmaceutical Company Limited
Enrollment
100
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 27, 2011
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •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\.

Exclusion Criteria

  • •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\)

Outcomes

Primary Outcomes

Not specified

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