Conditions: Major Depressive Disorder
Keywords: depression
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 142
Healthy volunteers: no

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.

Arms:
arm 1: BCI-024: over-encapsulated Buspirone tablet 15 mg at bedtime(QD) and BCI-049: over-encapsulated Melatonin tablet 3 mg QD arm 2: BCI-024: over-encapsulated Buspirone 15 mg QD arm 3: Placebo: 1 capsule QD

Interventions: intervention 1: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD intervention 2: BCI-024 (Buspirone) intervention 3: Matching placebo
Intervention descriptions: intervention 1: 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 2: Drug BCI-024 (Buspirone) taken once a day at bedtime for 6 weeks. intervention 3: Placebo comparator once a day at bedtime for 6 weeks.

Protocol document: