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

NCT00705003 | Completed Phase 2 Results

• 1 other identifier: CBM-IT-01
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 9

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.

Conditions

Major Depressive Disorder

Keywords

depression

Outcome Measures

Primary Outcomes (1)

• The Score on the Clinical Global Impression-Improvement (CGI-I) at Week 6

  Clinical Global Impression (CGI) is a standardized, clinician-rated assessment designed to allow the clinician to rate severity of illness, change over time, and pharmacologic treatment effects with consideration of the patient's clinical condition and the severity of side effects experienced (Guy 1976). Specifically, it consists of two global subscales: Global Improvement (CGI-I) Severity of Illness (CGI-S) The CGI-I was administered at Weeks 2, 4 and 6. The CGI-I evaluation was performed with instruction to "Rate the patient's total improvement whether or not, in your judgment, it is due entirely to drug treatment." The Investigator was asked "Compared to the patient's condition at the Baseline visit, please assign a rating to how much the patient changed." Responses for the CGI-I evaluation included the following categories: 0: Not Assessed 1. Very much improved 2. Much improved 3. Minimally improved 4. No change 5. Minimally worse 6. Much worse 7. Very much worse

  Week 6

Secondary Outcomes (4)

• 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

Study Arms (3)

Active Drug Combination

EXPERIMENTAL

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

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

BCI-024 (Buspirone)

ACTIVE COMPARATOR

BCI-024: over-encapsulated Buspirone 15 mg QD

Drug: BCI-024 (Buspirone)

Matching placebo

PLACEBO COMPARATOR

Placebo: 1 capsule QD

Drug: Matching placebo

Interventions

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

Also known as: Buspar is the brand name of buspirone.

Active Drug Combination

BCI-024 (Buspirone) DRUG

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

Also known as: Buspar is the brand name of buspirone.

BCI-024 (Buspirone)

Matching placebo DRUG

Placebo comparator once a day at bedtime for 6 weeks.

Matching placebo

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 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.

You may not qualify if:

• 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.

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

Interventions

Buspirone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

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
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fava, Maurizio MD.

Study Record Dates

• First Submitted: June 23, 2008
• First Posted: June 25, 2008
• Study Start: May 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 18, 2014
• Results First Posted: June 18, 2014

Record last verified: 2014-06

Locations

US (9)