Major Depressive Disorder Clinical Trial
Official title:
An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder
Verified date | October 2013 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | January 2009 |
Est. primary completion date | December 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Institute of Medicine & Research, Inc. | Altanta | Georgia |
United States | FutureSearch Clinical Trials, L.P. | Austin | Texas |
United States | NorthCoast Clinical Trials | Beachwood | Ohio |
United States | FutureSearch Trials of Dallas, L.P. | Dallas | Texas |
United States | Collaborative Neuroscience Network, Inc. | Garden Grove | California |
United States | Claghorn-Lesem Research Clinic, Ltd. | Houston | Texas |
United States | CRI Worldwide | Philadelphia | Pennsylvania |
United States | Capital Clinical Research Associates | Rockville | Maryland |
United States | Synergy Research Centers | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | BrainCells Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. | Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment) | No |
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