Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT00731653
- Lead Sponsor
- Massachusetts General Hospital
- 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 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.
- Detailed Description
Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 81
- 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.
- Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Collaborative Neuroscience Network, Inc.
🇺🇸Garden Grove, California, United States
Synergy Research Centers
🇺🇸San Diego, California, United States
Atlanta Institute of Medicine & Research, Inc.
🇺🇸Altanta, Georgia, United States
Capital Clinical Research Associates
🇺🇸Rockville, Maryland, United States
NorthCoast Clinical Trials
🇺🇸Beachwood, Ohio, United States
CRI Worldwide
🇺🇸Philadelphia, Pennsylvania, United States
FutureSearch Clinical Trials, L.P.
🇺🇸Austin, Texas, United States
FutureSearch Trials of Dallas, L.P.
🇺🇸Dallas, Texas, United States
Claghorn-Lesem Research Clinic, Ltd.
🇺🇸Houston, Texas, United States