Efficacy and Safety Study of a Combination Product (BCI-024 and BCI-049) to Treat Major Depressive Disorder (MDD)

• Secondary efficacy endpoints will include the change from Baseline in the QIDS-SR16, the IDS-C30,the CGI-S, the HAM-A, and the CPFQ. [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
• The safety and tolerability of BCI-024 in combination with BCI-049 will be assessed based on reported adverse events, vital signs and laboratory tests. [ Time Frame: Weeks 0-6 ] [ Designated as safety issue: Yes ]

The primary objective of this study are to evaluate the synergistic effect of a combination product, consisting of BCI-024 and BCI-049, in reducing symptoms of depression in patients with Major Depressive Disorder.

The safety and tolerability of BCI-952 will also be evaluated as measured by adverse events and vital signs.

Approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria will be randomized in the study.

• Drug: Combination Product: BCI-024 + BCI-049
  BCI-024 and BCI-049 once a day at bedtime for 6 weeks
• Drug: BCI-024
  BCI-024 once a day at bedtime for 6 weeks.
• Drug: Placebo comparator
  Placebo comparator once a day at bedtime for 6 weeks.

• Experimental: 1
  BCI-024 and BCI-049
  Intervention: Drug: Combination Product: BCI-024 + BCI-049
• Active Comparator: 2
  BCI-024
  Intervention: Drug: BCI-024
• Placebo Comparator: 3
  Placebo
  Intervention: Drug: Placebo comparator

Inclusion Criteria:

• Subjects will be male and female subjects between the ages of 18 to 65 meeting the DSM-IV-TR criteria for Major Depressive Disorder with a 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.

Exclusion Criteria:

• 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 BCI-024 or BCI-049 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 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.