Trial · NCT00731653
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
NCT00731653, Phase 2, Completed, Massachusetts General Hospital; results first posted 2013-12-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD). Trials, record NCT00731653. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00731653
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
- NCT number
- NCT00731653
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 81 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Major Depressive Disorder
- Interventions
- Combination Product: BCI-024 + BCI-049
- First posted
- 2008-08-11
- Last updated
- 2013-12-17
- Results first posted
- 2013-12-17
- Limitations and caveats
- This was an open-label study. Conclusions regarding the efficacy of the combination study drug were not made.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. | Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. | Weeks 0-6 (study treatment) and Weeks 7 and 8 (post-treatment) | 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. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Safety and Tolerability Outcome Measure is Reported Adverse Events. | BCI-024 and BCI-049 (Buspirone and Melatonin) | 81 | participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | BCI-024 and BCI-049 (Buspirone and Melatonin) | 81 | |
| Overall Study | COMPLETED | BCI-024 and BCI-049 (Buspirone and Melatonin) | 72 | |
| Overall Study | NOT COMPLETED | BCI-024 and BCI-049 (Buspirone and Melatonin) | 9 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | BCI-024 and BCI-049 (Buspirone and Melatonin) | 13 | 81 | 14 |
| other | Somnolence | Nervous system disorders | BCI-024 and BCI-049 (Buspirone and Melatonin) | 6 | 81 | 6 |
| other | Dizziness | Nervous system disorders | BCI-024 and BCI-049 (Buspirone and Melatonin) | 5 | 81 | 5 |
| other | Diarrhea | Gastrointestinal disorders | BCI-024 and BCI-049 (Buspirone and Melatonin) | 7 | 81 | 7 |
| other | Dry Mouth | Gastrointestinal disorders | BCI-024 and BCI-049 (Buspirone and Melatonin) | 6 | 81 | 6 |
| other | Nausea | Gastrointestinal disorders | BCI-024 and BCI-049 (Buspirone and Melatonin) | 5 | 81 | 5 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BCI-024 and BCI-049 (Buspirone and Melatonin) | ||
| Total, other adverse events | BCI-024 and BCI-049 (Buspirone and Melatonin) | 42 | 81 |
| Total, serious adverse events | BCI-024 and BCI-049 (Buspirone and Melatonin) | 0 | 81 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00731653
GET https://conductscience.org/api/trials/v1/NCT00731653/registered