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NCT01880593 · ClinicalTrials.gov registry record · Phase 2
Ketamine Plus Lithium in Treatment-Resistant Depression
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 34
- Enrollment target
NCT01880593 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 34 participants.
The verdict
NCT01880593, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 34 participants
- Enrollment target
Study Summary
The purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention strategy for patients with treatment-resistant depression (TRD) who respond to an initial series of ketamine infusions. Ketamine is a Food and Drug Administration approved anesthetic (a drug used to produce loss of consciousness before and during surgery). Ketamine is not approved for the treatment of major depressive disorder and is considered experimental in this study. An additional purpose of this study is to research the effects of ketamine on brain function. You may qualify to take part in this research study because you have been diagnosed with major depressive disorder (MDD) and have not responded to past treatments.
Interventions
- DRUG Placebo
- DRUG Ketamine
- DRUG Lithium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01880593
The ClinicalTrials.gov registry entry for NCT01880593 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01880593 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01880593 about?
NCT01880593 is a clinical study titled "Ketamine Plus Lithium in Treatment-Resistant Depression". The purpose of this study is to test the antidepressant effect of ketamine when given repeatedly over a period of 1 week, as well as the use of Lithium as a relapse-prevention strategy for patients with treatment-resistant depression (TRD) who respond to an initial series of ketamine infusions. Keta...
What is the current status of trial NCT01880593?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2013-07. Estimated completion is 2016-11.
What interventions are being tested in trial NCT01880593?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), Lithium (DRUG).
Who is sponsoring clinical trial NCT01880593?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
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