Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)

Completed · Phase 2

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT00731653

Run by

Massachusetts General Hospital

People needed

81

Starts

2008-07-01

Expected to finish

2009-01-01

Last updated by the study team

2013-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.

Where it is running

• 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

Full record on ClinicalTrials.gov

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