Status:
COMPLETED
Major Depressive Disorder With Mixed Features - Extension
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Lurasidone HCl is a compound that is a candidate for the treatment of major depressive with mixed features.This clinical study is designed to test how well Lurasidone works to treat major depressive d...
Eligibility Criteria
Inclusion
- Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
- Subject has completed 6 weeks of treatment in Study D1050304 (NCT#01421134) or Study D1050305 (NCT#01423240).
- Subject is judged by the Investigator to be suitable for participation in a 12-week clinical trial involving open-label lurasidone treatment and is able to comply with the protocol in the opinion of the Investigator.
Exclusion
- Subject answers "yes" to "Suicidal Ideation" Item 4 or 5 on the C-SSRS (at time of evaluation) at baseline (Day 43 in Study D1050304 or D1050305).
- Subject is considered by the Investigator to be at imminent risk of suicide or injury to self, others, or property.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01423253
Start Date
September 1 2011
End Date
October 1 2013
Last Update
April 8 2016
Active Locations (17)
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1
Birmingham Psychiatry Pharmaceutical Studies, Inc
Birmingham, Alabama, United States, 35226
2
Synergy Clinical Research Center
Escondido, California, United States, 92025
3
Collaborative Neuro Science Network, Inc.
Garden Grove, California, United States, 92845
4
Stanford -VA Palo Alto Health Care System
Palo Alto, California, United States, 94304