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

NCT00731653 | Completed Phase 2 Results

• 1 other identifier: CBM-IT-01-EXT
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 9

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.

Conditions

Major Depressive Disorder

Keywords

depression; combination

Outcome Measures

Primary Outcomes (1)

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

  Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)

Study Arms (1)

1

EXPERIMENTAL

BCI-024 and BCI-049

Drug: Combination Product: BCI-024 + BCI-049

Interventions

Combination Product: BCI-024 + BCI-049 DRUG

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

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• BrainCells Inc.: collaborator

Study Sites (9)

Collaborative Neuroscience Network, Inc.

Garden Grove, California, 92845, United States

Location

Synergy Research Centers

San Diego, California, 91950, United States

Location

Atlanta Institute of Medicine & Research, Inc.

Altanta, Georgia, 30328, United States

Location

Capital Clinical Research Associates

Rockville, Maryland, 20852, United States

Location

NorthCoast Clinical Trials

Beachwood, Ohio, 44122, United States

Location

CRI Worldwide

Philadelphia, Pennsylvania, 19139, United States

Location

FutureSearch Clinical Trials, L.P.

Austin, Texas, 78756, United States

Location

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, 75231, United States

Location

Claghorn-Lesem Research Clinic, Ltd.

Houston, Texas, 77008, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

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

Results Point of Contact

• Title: Maurizio Fava, MD
• Organization: Massachusetts General Hospital

mfava@partners.org

617-724-2513

Study Officials

• Maurizio Fava, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Andrew A Nierenberg, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fava, Maurizio, MD

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: January 1, 2009
• Last Updated: December 17, 2013
• Results First Posted: December 17, 2013

Record last verified: 2013-10

Locations

US (9)