Status:
COMPLETED
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
BrainCells Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 ...
Detailed Description
Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.
Eligibility Criteria
Inclusion
- Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study.
- Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements.
Exclusion
- \- Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00731653
Start Date
July 1 2008
End Date
January 1 2009
Last Update
December 17 2013
Active Locations (9)
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1
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
2
Synergy Research Centers
San Diego, California, United States, 91950
3
Atlanta Institute of Medicine & Research, Inc.
Altanta, Georgia, United States, 30328
4
Capital Clinical Research Associates
Rockville, Maryland, United States, 20852