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NCT02397889 · ClinicalTrials.gov registry record · Phase 2
Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)
A Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT02397889: Completed Phase 2 study, sponsored by Icahn School of Medicine at Mount Sinai.
NCT02397889 is a Phase 2 study that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397889, a Phase 2 study, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repeatedly intravenously can produce a quick and persistent improvement in PTSD symptoms. At higher doses, ketamine has been used for many years as an anesthetic for medical procedures, and at lower doses may be an effective treatment in patients with major depression and PTSD. Ketamine given for PTSD is investigational, which means that the FDA has not yet approved the drug for treating this condition. In this study, the effects of ketamine will be compared to those of midazolam. Midazolam has similar acute anesthetic effects compared to ketamine but has not been shown to treat or alleviate any symptoms of PTSD. This makes midazolam an appropriate substance to gauge whether ketamine can treat or alleviate PTSD symptoms thereby acting as what we call an active control.
Primary Outcome
full range score from 0-80, with higher scores indicating greater PTSD symptoms
Interventions
- DRUG Ketamine
- DRUG Midazolam
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-05-18 |
| Est. Completion | 2020-01-27 |
| Phase | Phase 2 |
What the finished NCT02397889 record still lists
NCT02397889 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine is the first listed.
NCT02397889 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02397889 about?
NCT02397889 is a clinical study titled "Ketamine as a Treatment for Post-Traumatic Stress Disorder (PTSD)". The purpose of this study is to study new ways to treat post-traumatic stress disorder (PTSD). Current treatments for PTSD do not work for everyone and it can take time to determine whether a person responds to a chosen treatment. The purpose of this study is to see whether ketamine, when given repe...
What is the current status of trial NCT02397889?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2015-05-18. Estimated completion is 2020-01-27.
What interventions are being tested in trial NCT02397889?
The interventions under investigation include: Ketamine (DRUG), Midazolam (DRUG).
Who is sponsoring clinical trial NCT02397889?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02397889's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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