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NCT00705003 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 142
- Enrollment target
NCT00705003: Completed Phase 2 study, sponsored by Massachusetts General Hospital.
NCT00705003 is a Phase 2 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 142 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00705003, a Phase 2 study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 142 participants
- Enrollment target
Study 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.
Interventions
- DRUG Matching placebo
- DRUG BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD
- DRUG BCI-024 (Buspirone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 142 participants |
| Start Date | 2008-05 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00705003
The ClinicalTrials.gov registry entry for NCT00705003 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 142 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Matching placebo is the first listed.
NCT00705003 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00705003 about?
NCT00705003 is a clinical study titled "Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)". 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 pro...
What is the current status of trial NCT00705003?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 142 participants. The study started on 2008-05. Estimated completion is 2008-12.
What interventions are being tested in trial NCT00705003?
The interventions under investigation include: Matching placebo (DRUG), BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD (DRUG), BCI-024 (Buspirone) (DRUG).
Who is sponsoring clinical trial NCT00705003?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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