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Sponsors and Collaborators: |
Massachusetts General Hospital BrainCells Inc. |
Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00705003 |
The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of BCI-024 and BCI-049, in reducing symptoms of depression in patients with Major Depressive Disorder.
The safety and tolerability of BCI-952 will also be evaluated as measured by adverse events and vital signs.
Condition | Intervention |
Major Depressive Disorder |
Drug: Combination Product: BCI-024 + BCI-049 Drug: BCI-024 Drug: Placebo comparator |
MedlinePlus related topics: | Depression |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Double-Blind, Placebo-Controlled Study of a Combination Product (BCI-024 and BCI-049) in Patients With Major Depressive Disorder (MDD) |
Estimated Enrollment: | 120 |
Study Start Date: | May 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
BCI-024 and BCI-049
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Drug: Combination Product: BCI-024 + BCI-049
BCI-024 and BCI-049 once a day at bedtime for 6 weeks
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2: Active Comparator
BCI-024
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Drug: BCI-024
BCI-024 once a day at bedtime for 6 weeks.
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3: Placebo Comparator
Placebo
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Drug: Placebo comparator
Placebo comparator once a day at bedtime for 6 weeks.
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Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Steven Targum, MD | sdtargum@yahoo.com | |
Contact: Jill DeFratis-Robinson, BS | jrobinson@braincellsinc.com |
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FutureSearch Trials of Dallas, L.P. | Recruiting | ||||
Dallas, Texas, United States, 75231 | |||||
FutureSearch Clinical Trials, L.P. | Recruiting | ||||
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Claghorn-Lesem Research Clinic, Ltd. | Recruiting | ||||
Houston, Texas, United States, 77008 |
Massachusetts General Hospital |
BrainCells Inc. |
Principal Investigator: | Maurizio Fava, MD | Massachusetts General Hospital |
Principal Investigator: | Andrew A Nierenberg, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Maurizio Fava, MD ) |
Study ID Numbers: | CBM-IT-01 |
First Received: | June 23, 2008 |
Last Updated: | June 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00705003 |
Health Authority: | United States: Institutional Review Board |
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