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

NCT ID: NCT00705003

Last Updated: 2014-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-12-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Drug Combination

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

BCI-024 (Buspirone)

BCI-024: over-encapsulated Buspirone 15 mg QD

Group Type: ACTIVE_COMPARATOR

BCI-024 (Buspirone)

Intervention Type: DRUG

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

Matching placebo

Placebo: 1 capsule QD

Group Type: PLACEBO_COMPARATOR

Matching placebo

Intervention Type: DRUG

Placebo comparator once a day at bedtime for 6 weeks.

Interventions

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

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

Intervention Type: DRUG

BCI-024 (Buspirone)

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

Intervention Type: DRUG

Matching placebo

Placebo comparator once a day at bedtime for 6 weeks.

Intervention Type: DRUG

Other Intervention Names

Buspar is the brand name of buspirone.; Buspar is the brand name of buspirone.

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BrainCells Inc.

INDUSTRY

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Maurizio Fava, MD

Fava, Maurizio MD.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maurizio Fava, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Andrew A Nierenberg, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Collaborative Neuroscience Network, Inc.

Garden Grove, California, United States

Synergy Research Centers

San Diego, California, United States

Atlanta Institute of Medicine & Research, Inc.

Altanta, Georgia, United States

Capital Clinical Research Associates

Rockville, Maryland, United States

NorthCoast Clinical Trials

Beachwood, Ohio, United States

CRI Worldwide

Philadelphia, Pennsylvania, United States

FutureSearch Clinical Trials, L.P.

Austin, Texas, United States

FutureSearch Trials of Dallas, L.P.

Dallas, Texas, United States

Claghorn-Lesem Research Clinic, Ltd.

Houston, Texas, United States

Countries

United States

Other Identifiers

CBM-IT-01

Identifier Type: -

Identifier Source: org_study_id