Efficacy and Safety Study of a Combination Product [Drug:BCI-024 (Buspirone) and Drug:BCI-049 (Melatonin)] to Treat Major Depressive Disorder (MDD)
Public ClinicalTrials.gov record NCT00705003. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-Controlled Study of a Combination Product (BCI-024 and BCI-049) in Patients With Major Depressive Disorder (MDD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00705003
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 142 participants
Conditions and interventions
Conditions
Interventions
- BCI-024: over-encapsulated Buspirone tablet 15 mg QD and BCI-049: over-encapsulated Melatonin tablet 3 mg QD Drug
- BCI-024 (Buspirone) Drug
- Matching placebo Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 30, 2008
- Primary completion
- Nov 30, 2008
- Completion
- Nov 30, 2008
- Last update posted
- Jun 17, 2014
2008
United States locations
- U.S. sites
- 9
- U.S. states
- 6
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Collaborative Neuroscience Network, Inc. | Garden Grove | California | 92845 | — |
| Synergy Research Centers | San Diego | California | 91950 | — |
| Atlanta Institute of Medicine & Research, Inc. | Altanta | Georgia | 30328 | — |
| Capital Clinical Research Associates | Rockville | Maryland | 20852 | — |
| NorthCoast Clinical Trials | Beachwood | Ohio | 44122 | — |
| CRI Worldwide | Philadelphia | Pennsylvania | 19139 | — |
| FutureSearch Clinical Trials, L.P. | Austin | Texas | 78756 | — |
| FutureSearch Trials of Dallas, L.P. | Dallas | Texas | 75231 | — |
| Claghorn-Lesem Research Clinic, Ltd. | Houston | Texas | 77008 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00705003, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 17, 2014 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00705003 live on ClinicalTrials.gov.