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

Major Depressive Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731653
• Other study ID #: CBM-IT-01-EXT
• Status: Completed
• Phase: Phase 2
• First received: August 7, 2008
• Last updated: October 24, 2013
• Start date: July 2008
• Est. completion date: January 2009

Study information

• Verified date: October 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Combination Product: BCI-024 + BCI-049
BCI-024 and BCI-049 once a day at bedtime for 6 weeks

Locations

Country	Name	City	State
United States	Atlanta Institute of Medicine & Research, Inc.	Altanta	Georgia
United States	FutureSearch Clinical Trials, L.P.	Austin	Texas
United States	NorthCoast Clinical Trials	Beachwood	Ohio
United States	FutureSearch Trials of Dallas, L.P.	Dallas	Texas
United States	Collaborative Neuroscience Network, Inc.	Garden Grove	California
United States	Claghorn-Lesem Research Clinic, Ltd.	Houston	Texas
United States	CRI Worldwide	Philadelphia	Pennsylvania
United States	Capital Clinical Research Associates	Rockville	Maryland
United States	Synergy Research Centers	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	BrainCells Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.		Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)	No