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

NCT ID: NCT00731653

Last Updated: 2013-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-01-31

Brief Summary

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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

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

Conditions

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Major Depressive Disorder

Keywords

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depression combination

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

BCI-024 and BCI-049

Group Type EXPERIMENTAL

Combination Product: BCI-024 + BCI-049

Intervention Type DRUG

BCI-024 and BCI-049 once a day at bedtime for 6 weeks

Interventions

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Combination Product: BCI-024 + BCI-049

BCI-024 and BCI-049 once a day at bedtime for 6 weeks

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BrainCells Inc.

INDUSTRY

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Maurizio Fava, MD

Fava, Maurizio, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maurizio Fava, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Andrew A Nierenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Site Status

Synergy Research Centers

San Diego, California, United States

Site Status

Atlanta Institute of Medicine & Research, Inc.

Altanta, Georgia, United States

Site Status

Capital Clinical Research Associates

Rockville, Maryland, United States

Site Status

NorthCoast Clinical Trials

Beachwood, Ohio, United States

Site Status

CRI Worldwide

Philadelphia, Pennsylvania, United States

Site Status

FutureSearch Clinical Trials, L.P.

Austin, Texas, United States

Site Status

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, United States

Site Status

Claghorn-Lesem Research Clinic, Ltd.

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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CBM-IT-01-EXT

Identifier Type: -

Identifier Source: org_study_id