Long-Term Extension Study of Lu AA21004 in Participants With Major Depressive Disorder
NCT01395147 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 119
Last updated 2013-11-05
Summary
The purpose of this study is to assess the safety and efficacy of Lu AA21004 in participants with major depressive disorder after completion of an 8-week double-blind treatment period in a preceding study (Lu AA21004/CCT-003; NCT01355081).
Conditions
Interventions
- DRUG
-
Lu AA21004
Lu AA21004 10 mg, tablets, orally, once daily for 2 weeks; reduced to 5 mg or increased to 20 mg, once daily if necessary according to the responses and symptoms of participants for up to 50 weeks.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Senior Director · Takeda
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-07-31
- Primary Completion
- 2013-05-31
- Completion
- 2013-05-31
Countries
- Japan
Study Locations
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