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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: Completed Phase 1 study, sponsored by Grace Lim, MD, MS.
NCT05907213 is a Phase 1 study that has completed, run by Grace Lim, MD, MS. 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
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.
Primary Outcome
Maximum tolerated dose of ketamine is measured by dose that fewer than 33% of patients experience a dose-limiting toxicity (DLT) defined by intolerability. Tolerability will be defined as: lack of adverse events (adverse event defined as: severe unresolved hemodynamic effect: systolic blood pressure \<80 or \>160, heart rate \<40 or \>120). Intolerability will be defined as presence of any adverse event (i.e., severe unresolved hemodynamic effect: systolic blood pressure \<80 or \>160, heart rat
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 |
What the finished NCT05907213 record still lists
NCT05907213 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 4 interventions - of which Ketamine (Ketalar) Dose Level 1 is the first listed.
NCT05907213 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05907213'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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