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| Name | Class |
|---|---|
| BrainCells Inc. | INDUSTRY |
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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.
Up to approximately 120 adult outpatients meeting the study's inclusion and exclusion criteria may be enrolled in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | BCI-024 and BCI-049 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combination Product: BCI-024 + BCI-049 | Drug | BCI-024 and BCI-049 once a day at bedtime for 6 weeks |
|
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
- Subjects who did not complete their participation in Protocol CBM-IT-01 are not eligible for the study.
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| Name | Affiliation | Role |
|---|---|---|
| Maurizio Fava, MD | Massachusetts General Hospital | Principal Investigator |
| Andrew A Nierenberg, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | United States | ||
| Synergy Research Centers |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | BCI-024 and BCI-049 (Buspirone and Melatonin) | BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| San Diego |
| California |
| 91950 |
| United States |
| Atlanta Institute of Medicine & Research, Inc. | Altanta | Georgia | 30328 | United States |
| Capital Clinical Research Associates | Rockville | Maryland | 20852 | United States |
| NorthCoast Clinical Trials | Beachwood | Ohio | 44122 | United States |
| CRI Worldwide | Philadelphia | Pennsylvania | 19139 | United States |
| FutureSearch Clinical Trials, L.P. | Austin | Texas | 78756 | United States |
| FutureSearch Trials of Dallas, L.P. | Dallas | Texas | 75231 | United States |
| Claghorn-Lesem Research Clinic, Ltd. | Houston | Texas | 77008 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BCI-024 and BCI-049 (Buspirone and Melatonin) | BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. | 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. | Posted | Number | participants | Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment) |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BCI-024 and BCI-049 (Buspirone and Melatonin) | BCI-024 (Buspirone)30 mg QD and BCI-049 (Melatonin) 6 mg QD Open-label | 0 | 81 | 42 | 81 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
This was an open-label study. Conclusions regarding the efficacy of the combination study drug were not made.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maurizio Fava, MD | Massachusetts General Hospital | 617-724-2513 | mfava@partners.org |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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