Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD; BCI-024 (Buspirone); Matching placebo
Intervention description: 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) taken once a day at bedtime for 6 weeks.; Placebo comparator once a day at bedtime for 6 weeks.
Intervention MeSH terms: Melatonin; Buspirone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: depression

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be male and female subjects between the ages of 18 to 65 meeting the
             Diagnostic and Statistical Manual of Mental Disorders-IV-Text Revision (DSM-IV-TR)
             criteria for Major Depressive Disorder with a Quick Inventory of Depressive
             Symptomatology-16 Item Self Report (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 buspirone or melatonin 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 selective serotonin reuptake inhibitors (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.