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NCT00731653 · ClinicalTrials.gov registry record · Phase 2
Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)
A Phase 2 study of Major Depressive Disorder, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 9
- Study locations
NCT00731653 is a Phase 2 study of Major Depressive Disorder that has completed, run by Massachusetts General Hospital. The registered enrollment target is 81 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (79% lower). The trial reports 9 study locations across 6 states.
The verdict
NCT00731653, a Phase 2 study of Major Depressive Disorder, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 81 participants
- Enrollment target
- 9
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Combination Product: BCI-024 + BCI-049
Study Locations (9)
Texas
- FutureSearch Clinical Trials, L.P. - Austin
- FutureSearch Trials of Dallas, L.P. - Dallas
- Claghorn-Lesem Research Clinic, Ltd. - Houston
California
- Collaborative Neuroscience Network, Inc. - Garden Grove
- Synergy Research Centers - San Diego
Georgia
- Atlanta Institute of Medicine & Research, Inc. - Altanta
Maryland
- Capital Clinical Research Associates - Rockville
Ohio
- NorthCoast Clinical Trials - Beachwood
Pennsylvania
- CRI Worldwide - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2008-07 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00731653
The ClinicalTrials.gov registry entry for NCT00731653 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (79% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Combination Product: BCI-024 + BCI-049 is the first listed.
NCT00731653 reports 9 study locations spanning 6 distinct geographic areas - top geographies include Texas, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00731653 about?
NCT00731653 is a clinical study titled "Open Label Extension Assessing the Tolerability of BCI-024 in Combination With BCI-049 in Patients With Major Depressive Disorder (MDD)". 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 dos...
What is the current status of trial NCT00731653?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2008-07. Estimated completion is 2009-01.
What conditions does trial NCT00731653 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT00731653?
The interventions under investigation include: Combination Product: BCI-024 + BCI-049 (DRUG).
Who is sponsoring clinical trial NCT00731653?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00731653 being conducted?
This trial has 9 study locations across California, Georgia, Maryland, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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