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

This study has been completed.
Sponsor:
Collaborator:
BrainCells Inc.
Information provided by (Responsible Party):
Maurizio Fava, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00731653
First received: August 7, 2008
Last updated: October 24, 2013
Last verified: October 2013
  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 Phase
Major Depressive Disorder
Drug: Combination Product: BCI-024 + BCI-049
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 ]

Enrollment: 81
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
Experimental: 1
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
FutureSearch Clinical Trials, L.P.
Austin, Texas, United States, 78756
FutureSearch Trials of Dallas, L.P.
Dallas, Texas, United States, 75231
Claghorn-Lesem Research Clinic, Ltd.
Houston, Texas, United States, 77008
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

No publications provided

Responsible Party: Maurizio Fava, MD, Fava, Maurizio, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00731653     History of Changes
Other Study ID Numbers: CBM-IT-01-EXT
Study First Received: August 7, 2008
Results First Received: October 24, 2013
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
depression
combination

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 18, 2014