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NCT00768430 · ClinicalTrials.gov registry record · Phase 2
Optimization of IV Ketamine for Treatment Resistant Depression
A Phase 2 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 73
- Enrollment target
NCT00768430: Completed Phase 2 study, sponsored by Baylor College of Medicine.
NCT00768430 is a Phase 2 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 73 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00768430, a Phase 2 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 73 participants
- Enrollment target
Study Summary
Existing treatments for major depressive disorder (MDD) generally take weeks to months to exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has been used as a standard intravenous (IV) anesthetic agent for many years in both pediatric and adult patients. Beyond its well-established role in anesthesia and pain management, there is emerging evidence that ketamine may have rapid antidepressant properties for patients with severe mood disorders. In this study we are investigating whether ketamine can have an antidepressant effect compared to midazolam. Midazolam has similar anesthetic effects compared to ketamine but has not been shown to be an antidepressant, and is therefore acting as an active control in this study. The study period can last up to 8 weeks, depending on your response to the study medication. There are two required overnight stays in our Research Commons as part of this study.
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.
Interventions
- DRUG Ketamine
- DRUG Midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 73 participants |
| Start Date | 2008-11 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT00768430 record still lists
NCT00768430 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 73 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT00768430 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00768430 about?
NCT00768430 is a clinical study titled "Optimization of IV Ketamine for Treatment Resistant Depression". Existing treatments for major depressive disorder (MDD) generally take weeks to months to exert their maximal benefit. There is an urgent need to develop rapid-acting treatments for MDD. Ketamine, a high-affinity N-methyl-D-aspartate (NMDA) glutamate receptor antagonist, has been used as a standard ...
What is the current status of trial NCT00768430?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 73 participants. The study started on 2008-11. Estimated completion is 2012-11.
What interventions are being tested in trial NCT00768430?
The interventions under investigation include: Ketamine (DRUG), Midazolam (DRUG).
Who is sponsoring clinical trial NCT00768430?
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 NCT00768430's enrollment target sits among peer trials
73 924th of 2000 higher than 1,076 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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