search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Combination Product: BCI-024 + BCI-049
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression, combination

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Collaborative Neuroscience Network, Inc.
  • Synergy Research Centers
  • Atlanta Institute of Medicine & Research, Inc.
  • Capital Clinical Research Associates
  • NorthCoast Clinical Trials
  • CRI Worldwide
  • FutureSearch Clinical Trials, L.P.
  • FutureSearch Trials of Dallas, L.P.
  • Claghorn-Lesem Research Clinic, Ltd.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

BCI-024 and BCI-049

Outcomes

Primary Outcome Measures

The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2008
Last Updated
October 24, 2013
Sponsor
Massachusetts General Hospital
Collaborators
BrainCells Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00731653
Brief Title
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
BrainCells Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
depression, combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
BCI-024 and BCI-049
Intervention Type
Drug
Intervention Name(s)
Combination Product: BCI-024 + BCI-049
Intervention Description
BCI-024 and BCI-049 once a day at bedtime for 6 weeks
Primary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maurizio Fava, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew A Nierenberg, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Collaborative Neuroscience Network, Inc.
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Synergy Research Centers
City
San Diego
State/Province
California
ZIP/Postal Code
91950
Country
United States
Facility Name
Atlanta Institute of Medicine & Research, Inc.
City
Altanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Capital Clinical Research Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
NorthCoast Clinical Trials
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
CRI Worldwide
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
FutureSearch Clinical Trials, L.P.
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
FutureSearch Trials of Dallas, L.P.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Claghorn-Lesem Research Clinic, Ltd.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs