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

Sponsors and Collaborators:	Massachusetts General Hospital BrainCells Inc.
Information provided by:	Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00731653

Purpose

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.

Condition	Intervention
Major Depressive Disorder	Drug: Combination Product: BCI-024 + BCI-049

MedlinePlus related topics: Depression

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:

The primary safety and tolerability outcome measure is reported adverse events. [ Time Frame: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The primary efficacy outcome measure is the score on the Clinical Global Impression-Improvement (CGI-I). [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	July 2008
Study Completion Date:	January 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental BCI-024 and BCI-049	Drug: Combination Product: BCI-024 + BCI-049 BCI-024 and BCI-049 once a day at bedtime for 6 weeks

Detailed Description:

Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731653

Locations

United States, California
Collaborative Neuroscience Network, Inc.
Garden Grove, California, United States, 92845
Synergy Research Centers
San Diego, California, United States, 91950
United States, Georgia
Atlanta Institute of Medicine & Research, Inc.
Altanta, Georgia, United States, 30328
United States, Maryland
Capital Clinical Research Associates
Rockville, Maryland, United States, 20852
United States, Ohio
NorthCoast Clinical Trials
Beachwood, Ohio, United States, 44122
United States, Pennsylvania
CRI Worldwide
Philadelphia, Pennsylvania, United States, 19139
United States, Texas
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, United States, 77008
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States, 78756
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States, 75231

Sponsors and Collaborators

Massachusetts General Hospital

BrainCells Inc.

Investigators

Principal Investigator:	Maurizio Fava, MD	Massachusetts General Hospital
Principal Investigator:	Andrew A Nierenberg, MD	Massachusetts General Hospital

More Information

Responsible Party:	Massachusetts General Hospital ( Maurizio Fava, MD )
Study ID Numbers:	CBM-IT-01-EXT
Study First Received:	August 7, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00731653
Health Authority:	United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:

depression
combination

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Pathologic Processes
Disease

ClinicalTrials.gov processed this record on February 06, 2009