Efficacy and Safety Study of a Combination Product (BCI-024 and BCI-049) to Treat Major Depressive Disorder (MDD)

This study has been completed.
Sponsor:
Collaborator:
BrainCells Inc.
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00705003
First received: June 23, 2008
Last updated: January 29, 2009
Last verified: January 2009
  Purpose

The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of BCI-024 and BCI-049, in reducing symptoms of depression in patients with Major Depressive Disorder.

The safety and tolerability of BCI-952 will also be evaluated as measured by adverse events and vital signs.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of a Combination Product (BCI-024 and BCI-049) in Patients With Major Depressive Disorder (MDD)

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • The primary endpoint is the score on the Clinical Global Impression-Improvement (CGI-I) [ Time Frame: Week 6 (end of study treatment). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary efficacy endpoints will include the change from Baseline in the QIDS-SR16, the IDS-C30,the CGI-S, the HAM-A, and the CPFQ. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  • The safety and tolerability of BCI-024 in combination with BCI-049 will be assessed based on reported adverse events, vital signs and laboratory tests. [ Time Frame: Weeks 0-6 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: May 2008
Study Completion Date: December 2008
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
Active Comparator: 2
BCI-024
Drug: BCI-024
BCI-024 once a day at bedtime for 6 weeks.
Placebo Comparator: 3
Placebo
Drug: Placebo comparator
Placebo comparator once a day at bedtime for 6 weeks.

Detailed Description:

Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized 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 will be male and female subjects between the ages of 18 to 65 meeting the DSM-IV-TR criteria for Major Depressive Disorder with a QIDS-SR16 score of >14 at the Screening and Baseline Visits.
  • Female subjects must be on a stable and medically reliable form of birth control, must agree to continue use of this birth control during the study, and must have negative urine pregnancy tests at the Screening Visit.

Exclusion Criteria:

  • Subjects with any other psychiatric Axis-I disorder as a principal diagnosis within 6 months of screening or subjects with a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, or mental retardation at any time are not eligible for the study.
  • Subjects who pose a suicidal risk or who have a history of eating disorder or substance dependence within 6 months of screening, or a history of substance abuse within 3 months of screening are also ineligible.
  • Subjects with clinically significant abnormalities on any Screening or Baseline assessments, including laboratory tests, are excluded.
  • Subjects with a known intolerance to either BCI-024 or BCI-049 are excluded, as are subjects with clinically significant medical or psychiatric conditions that might be detrimental to the subject should they participate in the study.
  • Subjects who have used SSRIs within 2 weeks of Screening (within 4 weeks for fluoxetine) are excluded as are subjects requiring concomitant use of antipsychotic and anxiolytic medications and any drugs with known psychotropic properties. Concomitant medications that are not excluded by the protocol and that are taken chronically must be at a stable dosage for at least 4 weeks prior to screening.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00705003

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, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00705003     History of Changes
Other Study ID Numbers: CBM-IT-01
Study First Received: June 23, 2008
Last Updated: January 29, 2009
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 April 16, 2014