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NCT05907213 · ClinicalTrials.gov registry record · Phase 1
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
A Phase 1 study, sponsored by Grace Lim, MD, MS.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT05907213 is a Phase 1 study that has completed, run by Grace Lim, MD, MS. The registered enrollment target is 12 participants.
The verdict
NCT05907213, a Phase 1 study, has completed, sponsored by Grace Lim, MD, MS.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design. A loading dose over 1 hour will be the MTD variable to be tested, as our data suggest that ketamine side effects occur with the loading dose. The investigators hypothesize that subanesthetic ketamine dose will be well tolerated and any noted side effects will be rated acceptable by postpartum women following cesarean delivery.
Interventions
- DRUG Ketamine (Ketalar) Dose Level 1
- DRUG Ketamine (Ketalar) Dose Level 2
- DRUG Ketamine (Ketalar) Dose Level 3
- DRUG Ketamine (Ketalar) Dose Level 4
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-09-25 |
| Est. Completion | 2024-09-19 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05907213
The ClinicalTrials.gov registry entry for NCT05907213 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Grace Lim, MD, MS, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Ketamine (Ketalar) Dose Level 1 is the first listed.
NCT05907213 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05907213 about?
NCT05907213 is a clinical study titled "Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)". The purpose of this study is to identify a tolerable dose for postpartum ketamine infusion using a maximum tolerated dose (MTD) 3+3 design. A loading dose over 1 hour will be the MTD variable to be tested, as our data suggest that ketamine side effects occur with the loading dose. The investigators ...
What is the current status of trial NCT05907213?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-09-25. Estimated completion is 2024-09-19.
What interventions are being tested in trial NCT05907213?
The interventions under investigation include: Ketamine (Ketalar) Dose Level 1 (DRUG), Ketamine (Ketalar) Dose Level 2 (DRUG), Ketamine (Ketalar) Dose Level 3 (DRUG), Ketamine (Ketalar) Dose Level 4 (DRUG).
Who is sponsoring clinical trial NCT05907213?
This trial is sponsored by Grace Lim, MD, MS, which has 10 total clinical trials registered on ClinicalTrials.gov.
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