Major Depressive Disorder
Conditions
Keywords
depression, combination
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.
Interventions
DRUGCombination Product: BCI-024 + BCI-049
BCI-024 and BCI-049 once a day at bedtime for 6 weeks
Sponsors
BrainCells Inc.
Massachusetts General Hospital
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who are willing to provide written informed consent and who have completed participation in Protocol CBM-IT-01 are eligible for the study. * Eligible subjects will have demonstrated compliance with all CBM-IT-01's protocol requirements.
Exclusion criteria
\- Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. | Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment) |
Countries
United States
Participant flow
Recruitment details
Following their participation in the CBM-IT-01 study, subjects were offered the opportunity to participate in this open-label extension study. The study was conducted 9 study centers between June 2008 and February 2009.
Participants by arm
| Arm | Count |
|---|---|
| BCI-024 and BCI-049 (Buspirone and Melatonin) BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label | 81 |
| Total | 81 |
Baseline characteristics
| Characteristic | BCI-024 and BCI-049 (Buspirone and Melatonin) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 81 Participants |
| Age Continuous | 43.7 years STANDARD_DEVIATION 11.59 |
| Region of Enrollment United States | 81 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 42 / 81 |
| serious Total, serious adverse events | 0 / 81 |
Outcome results
Primary
The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events.
Time frame: Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment)
Population: All patients who received at least one dose of study treatment during the extension phase were included in the analysis population. Analyses were performed with observed data. Tables and listings of safety and efficacy assessments will include all data observed. There was no imputation or adjustment for missing data values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BCI-024 and BCI-049 (Buspirone and Melatonin) | The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. | 81 participants |