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NCT03960658 · ClinicalTrials.gov registry record · Phase 1
Ketamine and Prolonged Exposure in PTSD
A Phase 1 study, sponsored by Minneapolis Veterans Affairs Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT03960658: Completed Phase 1 study, sponsored by Minneapolis Veterans Affairs Medical Center.
NCT03960658 is a Phase 1 study that has completed, run by Minneapolis Veterans Affairs Medical Center. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03960658, a Phase 1 study, has completed, sponsored by Minneapolis Veterans Affairs Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
This study aims at investigating the effectiveness of the drug, Ketamine, in combination with Prolonged Exposure (PE) therapy for people suffering from PTSD. Participation in the study includes Ketamine infusions, which occur once a week for three weeks. PE therapy sessions will be scheduled one day after each infusion, and may continue up to 12 weeks. After completely therapy, there will be two monthly follow-up assessment visits.
Primary Outcome
The overall severity of PTSD symptoms would be measured by the mean change in the Past Month (current) total scores on the Clinician-Administered PTSD Scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5) from baseline to post-treatment (10 weeks). The CAPS-5 is a structured interview with higher values representing worse outcomes. The CAPS-5 total symptom severity score ranges from 0 to 80 and it is calculated by summing severity scores for the 20 DSM-5 PTSD sy
Interventions
- DRUG ketamine-enhanced prolonged exposure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-04-03 |
| Est. Completion | 2019-12-04 |
| Phase | Phase 1 |
What the finished NCT03960658 record still lists
NCT03960658 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which ketamine-enhanced prolonged exposure is the first listed.
NCT03960658 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03960658 about?
NCT03960658 is a clinical study titled "Ketamine and Prolonged Exposure in PTSD". This study aims at investigating the effectiveness of the drug, Ketamine, in combination with Prolonged Exposure (PE) therapy for people suffering from PTSD. Participation in the study includes Ketamine infusions, which occur once a week for three weeks. PE therapy sessions will be scheduled one day...
What is the current status of trial NCT03960658?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2019-04-03. Estimated completion is 2019-12-04.
What interventions are being tested in trial NCT03960658?
The interventions under investigation include: ketamine-enhanced prolonged exposure (DRUG).
Who is sponsoring clinical trial NCT03960658?
This trial is sponsored by Minneapolis Veterans Affairs Medical Center, which has 28 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03960658's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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