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NCT00419003 · ClinicalTrials.gov registry record · Phase 4
Research Study for Major Depressive Disorder: Investigation of Glutamate Medications
A Phase 4 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT00419003: Completed Phase 4 study, sponsored by Baylor College of Medicine.
NCT00419003 is a Phase 4 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00419003, a Phase 4 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects associated with ketamine.
Primary Outcome
Montgomery-Asberg Depression Rating Scale, each of the ten items can be scored from 0 (absence of symptoms to 6 most severe) and has a total score range of 0-60. A lower score on a MADRS indicates a less severe depression. The primary outcome for the initial phase of the trial was the 24-h MADRS score, which included all 10 MADRS items.
Interventions
- DRUG Ketamine
- DRUG Lamotrigine
- DRUG Riluzole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2006-12 |
| Est. Completion | 2008-09 |
| Phase | Phase 4 |
What the finished NCT00419003 record still lists
NCT00419003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 3 interventions - of which Ketamine is the first listed.
NCT00419003 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00419003 about?
NCT00419003 is a clinical study titled "Research Study for Major Depressive Disorder: Investigation of Glutamate Medications". This study is examining the safety and effectiveness of two medications, ketamine and riluzole, in treating patients with treatment resistant major depressive disorder. This study will also examine the effectiveness of an FDA approved drug called lamotrigine in decreasing the potential side effects ...
What is the current status of trial NCT00419003?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2006-12. Estimated completion is 2008-09.
What interventions are being tested in trial NCT00419003?
The interventions under investigation include: Ketamine (DRUG), Lamotrigine (DRUG), Riluzole (DRUG).
Who is sponsoring clinical trial NCT00419003?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00419003's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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