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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00731653
• Collaborator: BrainCells Inc. (Industry)
• Enrollment: 81
• Locations: 9
• Arm: 1
• Duration (Months): 6
• Patients Per Site: 9
• Patients Per Site Per Month: 1.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Combination Product: BCI-024 + BCI-049	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 81 participants
• Intervention Model: Parallel Assignment
• Masking: None (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
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Dec 1, 2008
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. [Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Collaborative Neuroscience Network, Inc.	Garden Grove	California	United States	92845
2	Synergy Research Centers	San Diego	California	United States	91950
3	Atlanta Institute of Medicine & Research, Inc.	Altanta	Georgia	United States	30328
4	Capital Clinical Research Associates	Rockville	Maryland	United States	20852
5	NorthCoast Clinical Trials	Beachwood	Ohio	United States	44122
6	CRI Worldwide	Philadelphia	Pennsylvania	United States	19139
7	FutureSearch Clinical Trials, L.P.	Austin	Texas	United States	78756
8	FutureSearch Trials of Dallas, L.P.	Dallas	Texas	United States	75231
9	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Maurizio Fava, MD, Fava, Maurizio, MD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT00731653
• Other Study ID Numbers: CBM-IT-01-EXT
• First Posted: Aug 11, 2008
• Last Update Posted: Dec 17, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Maurizio Fava, MD, Fava, Maurizio, MD, Massachusetts General Hospital: depression; combination
• Additional relevant MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major

Study Results

Participant Flow

Recruitment Details	Following their participation in the CBM-IT-01 study, subjects were offered the opportunity to participate in this open-label extension study. The study was conducted 9 study centers between June 2008 and February 2009.

Arm/Group Title	BCI-024 and BCI-049 (Buspirone and Melatonin)
Arm/Group Description	BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
Period Title: Overall Study
STARTED	81
COMPLETED	72
NOT COMPLETED	9

Baseline Characteristics

Arm/Group Title	BCI-024 and BCI-049 (Buspirone and Melatonin)
Arm/Group Description	BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
Overall Participants	81
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	81 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.7 (11.59)
Sex: Female, Male (Count of Participants)
Female	53 65.4%
Male	28 34.6%
Region of Enrollment (participants) [Number]
United States	81 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

All patients who received at least one dose of study treatment during the extension phase were included in the analysis population. Analyses were performed with observed data. Tables and listings of safety and efficacy assessments will include all data observed. There was no imputation or adjustment for missing data values.

Arm/Group Title	BCI-024 and BCI-049 (Buspirone and Melatonin)
Arm/Group Description	BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
Measure Participants	81
Number [participants]	81 100%

Adverse Events

Arm/Group Title	BCI-024 and BCI-049 (Buspirone and Melatonin)
Arm/Group Description	BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label
All Cause Mortality
	BCI-024 and BCI-049 (Buspirone and Melatonin)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	BCI-024 and BCI-049 (Buspirone and Melatonin)
	Affected / at Risk (%)	# Events
Total	0/81 (0%)
Other (Not Including Serious) Adverse Events
	BCI-024 and BCI-049 (Buspirone and Melatonin)
	Affected / at Risk (%)	# Events
Total	42/81 (51.9%)
Gastrointestinal disorders
Diarrhea	7/81 (8.6%)	7
Dry Mouth	6/81 (7.4%)	6
Nausea	5/81 (6.2%)	5
Nervous system disorders
Headache	13/81 (16%)	14
Somnolence	6/81 (7.4%)	6
Dizziness	5/81 (6.2%)	5

Limitations/Caveats

This was an open-label study. Conclusions regarding the efficacy of the combination study drug were not made.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.