Conditions: Major Depressive Disorder
Keywords: depression combination
Allocation:  | Intervention model: PARALLEL
Enrollment: 81
Healthy volunteers: no

Brief summary:
The objective of this study is to allow patients who have participated in the precursor study of BCI-024 in combination with BCI-049 versus placebo or BCI-024 alone (Protocol #CBM-IT-01) to receive 6 weeks of open-label treatment with an increased dose of BCI-024 in combination with an increased dose of BCI-049.

The safety and tolerability of this higher dose of the combination will be evaluated, as will the treatment effect in reducing symptoms of depression in patients with MDD.

Detailed description:
Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.

Arms:
arm 1: BCI-024 and BCI-049

Interventions: intervention 1: Combination Product: BCI-024 + BCI-049
Intervention descriptions: intervention 1: BCI-024 and BCI-049 once a day at bedtime for 6 weeks

Protocol document: