Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)

A Double-Blind, Placebo-Controlled Study of a Combination Product (BCI-024 and BCI-049) in Patients With Major Depressive Disorder (MDD)

Sponsors

Lead Sponsor: Massachusetts General Hospital

Collaborator: BrainCells Inc.

Source Massachusetts General Hospital
Brief Summary

The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of drug BCI-024 (buspirone) and drug BCI-049 (melatonin), in reducing symptoms of depression in patients with Major Depressive Disorder. The safety and tolerability of the combination product will also be evaluated as measured by adverse events and vital signs.

Detailed Description

Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.

Overall Status Completed
Start Date 2008-05-01
Completion Date 2008-12-01
Primary Completion Date 2008-12-01
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6 Week 6
Secondary Outcome
Measure Time Frame
The Change From Baseline in the CGI-S at Week 6 Baseline and Week 6
The Change From Baseline in the IDS-C30 at Week 6 Week 0 and Week 6
The Change From Baseline in the Quick Inventory of Depressive Symptomatology - 16 Item Self-Report (QIDS-SR16) at Week 6 Baseline and Week 6
The Change From Baseline on the HAM-A at Week 6 Week 0 and Week 6
Enrollment 142
Condition
Intervention

Intervention Type: Drug

Intervention Name: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD

Description: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and Drug BCI-049: over-encapsulated Melatonin tablet 3 mg QD taken in combination for 6 weeks

Arm Group Label: Active Drug Combination

Other Name: Buspar is the brand name of buspirone.

Intervention Type: Drug

Intervention Name: BCI-024 (Buspirone)

Description: Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks.

Arm Group Label: BCI-024 (Buspirone)

Other Name: Buspar is the brand name of buspirone.

Intervention Type: Drug

Intervention Name: Matching placebo

Description: Placebo comparator once a day at bedtime for 6 weeks.

Arm Group Label: Matching placebo

Eligibility

Criteria:

Inclusion Criteria: - Subjects will be male and female subjects between the ages of 18 to 65 meeting the Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR) criteria for Major Depressive Disorder with a Quick Inventory of Depressive Symptomatology-16 Item Self Report (QIDS-SR16) score of >14 at the Screening and Baseline Visits. - Female subjects must be on a stable and medically reliable form of birth control, must agree to continue use of this birth control during the study, and must have negative urine pregnancy tests at the Screening Visit. Exclusion Criteria: - Subjects with any other psychiatric Axis-I disorder as a principal diagnosis within 6 months of screening or subjects with a history of obsessive compulsive disorder, psychotic disorder, bipolar disorder, or mental retardation at any time are not eligible for the study. - Subjects who pose a suicidal risk or who have a history of eating disorder or substance dependence within 6 months of screening, or a history of substance abuse within 3 months of screening are also ineligible. - Subjects with clinically significant abnormalities on any Screening or Baseline assessments, including laboratory tests, are excluded. - Subjects with a known intolerance to either buspirone or melatonin are excluded, as are subjects with clinically significant medical or psychiatric conditions that might be detrimental to the subject should they participate in the study. - Subjects who have used selective serotonin reuptake inhibitors (SSRIs) within 2 weeks of Screening (within 4 weeks for fluoxetine) are excluded as are subjects requiring concomitant use of antipsychotic and anxiolytic medications and any drugs with known psychotropic properties. Concomitant medications that are not excluded by the protocol and that are taken chronically must be at a stable dosage for at least 4 weeks prior to screening.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Location
Facility:
Collaborative Neuroscience Network, Inc. | Garden Grove, California, 92845, United States
Synergy Research Centers | San Diego, California, 91950, United States
Atlanta Institute of Medicine & Research, Inc. | Altanta, Georgia, 30328, United States
Capital Clinical Research Associates | Rockville, Maryland, 20852, United States
NorthCoast Clinical Trials | Beachwood, Ohio, 44122, United States
CRI Worldwide | Philadelphia, Pennsylvania, 19139, United States
FutureSearch Clinical Trials, L.P. | Austin, Texas, 78756, United States
FutureSearch Trials of Dallas, L.P. | Dallas, Texas, 75231, United States
Claghorn-Lesem Research Clinic, Ltd. | Houston, Texas, 77008, United States
Location Countries

United States

Verification Date

2014-06-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Massachusetts General Hospital

Investigator Full Name: Maurizio Fava, MD

Investigator Title: Fava, Maurizio MD.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Active Drug Combination

Type: Experimental

Description: BCI-024: over-encapsulated Buspirone tablet 15 mg at bedtime(QD) and BCI-049: over-encapsulated Melatonin tablet 3 mg QD

Label: BCI-024 (Buspirone)

Type: Active Comparator

Description: BCI-024: over-encapsulated Buspirone 15 mg QD

Label: Matching placebo

Type: Placebo Comparator

Description: Placebo: 1 capsule QD

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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