NCT00705003 - Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD) | Biotech Hunter

Enrollment

142

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions

Major Depressive Disorder

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.

Trial Locations (9)

CRI Worldwide, Philadelphia

Capital Clinical Research Associates, Rockville

Atlanta Institute of Medicine & Research, Inc., Altanta

NorthCoast Clinical Trials, Beachwood

FutureSearch Trials of Dallas, L.P., Dallas

Claghorn-Lesem Research Clinic, Ltd., Houston

FutureSearch Clinical Trials, L.P., Austin

Synergy Research Centers, San Diego

Collaborative Neuroscience Network, Inc., Garden Grove