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

NCT00705003 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2014-06-18

Study results available
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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

Interventions

DRUG

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

DRUG

BCI-024 (Buspirone)

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

DRUG

Matching placebo

Placebo comparator once a day at bedtime for 6 weeks.

Sponsors & Collaborators

  • BrainCells Inc.

    collaborator INDUSTRY

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Maurizio Fava, MD · Massachusetts General Hospital

  • Andrew A Nierenberg, MD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00705003 on ClinicalTrials.gov