Long-Term Extension Study of Lu AA21004 in Participants With Major Depressive Disorder

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Takeda
• Treatments: Vortioxetine

Criteria

Inclusion Criteria:

1. Has completed the double-blind treatment period of the preceding study (CCT-003)

2. Signs and dates a written, informed consent form for this study, different from that for the preceding study (CCT-003).

3. 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. 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. 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)