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

October 24, 2013 updated by: Maurizio Fava, MD, Massachusetts General Hospital

An Open-Label Extension Study to Assess the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

81

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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)
Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

BrainCells Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

January 1, 2009

Study Registration Dates

First Submitted

August 7, 2008

First Submitted That Met QC Criteria

August 7, 2008

First Posted (ESTIMATE)

August 11, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2013

Last Update Submitted That Met QC Criteria

October 24, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBM-IT-01-EXT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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