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NCT01260649 · ClinicalTrials.gov registry record · Phase 4
N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT01260649: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01260649 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 17 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01260649, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
Electroconvulsive therapy (ECT), is considered the most effective treatment for severe treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of treatments and can cause considerable acute deficits in memory. It would be a major advance in treatment if ECT could work faster with fewer treatments and result in decrease incidence of memory problems. Ketamine is an excellent candidate for augmentation of ECT because of its acute effects on depression, its short half-life, and its safety profile when given at low doses. Ketamine is given as an infusion and could easily be incorporated into the routine management of patients undergoing ECT, but has never been evaluated prospectively in this context. The investigators propose to assess the efficacy, feasibility, tolerability and safety of N-methyl-D-aspartate antagonist augmentation of ECT using ketamine.
Interventions
- DRUG ketamine
- PROCEDURE ECT
- OTHER IV Saline
- DRUG Muscle Relaxant
- DRUG Anesthetic Agents
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2010-11-01 |
| Est. Completion | 2012-11-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01260649
The ClinicalTrials.gov registry entry for NCT01260649 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 17 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 5 interventions - of which ketamine is the first listed.
NCT01260649 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01260649 about?
NCT01260649 is a clinical study titled "N-methyl-D-aspartate Antagonist (Ketamine) Augmentation of Electroconvulsive Treatment for Severe Major Depression". Electroconvulsive therapy (ECT), is considered the most effective treatment for severe treatment resistant major depressive disorder (MDD), but it requires about 3 weeks of treatments and can cause considerable acute deficits in memory. It would be a major advance in treatment if ECT could work fast...
What is the current status of trial NCT01260649?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2010-11-01. Estimated completion is 2012-11-01.
What interventions are being tested in trial NCT01260649?
The interventions under investigation include: ketamine (DRUG), ECT (PROCEDURE), IV Saline (OTHER), Muscle Relaxant (DRUG), Anesthetic Agents (DRUG).
Who is sponsoring clinical trial NCT01260649?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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