Overview
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
Status:
Completed
Completed
Trial end date:
2009-01-01
2009-01-01
Target enrollment:
0
0
Participant gender:
All
All
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 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049. The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Massachusetts General HospitalCollaborator:
BrainCells Inc.
Criteria
Inclusion Criteria:- 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 Criteria:
- Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible
for the study.