Trial Outcomes & Findings for Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1) (NCT NCT05907213)
NCT ID: NCT05907213
Last Updated: 2025-09-12
Results Overview
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 rate \<40 or \>120). Outcome measure of tolerability and intolerability will be reported as n (%). The MTD was 0.18 mg/kg/hr for one hour, followed by 0.05 mg/kg/hr for 11 hours.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Between 0 to 24 hours postpartum
Results posted on
2025-09-12
Participant Flow
Participant milestones
| Measure |
Ketamine (Ketalar) Dose Level 1
Ketamine (Ketalar) Dose Level 1: Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 2
Ketamine (Ketalar) Dose Level 2: Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 3
Ketamine (Ketalar) Dose Level 3: Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 4
Ketamine (Ketalar) Dose Level 4: Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ketamine Tolerated Dose for Postpartum Depression and Pain After Cesarean Delivery (PREPARE 1)
Baseline characteristics by cohort
| Measure |
Ketamine (Ketalar) Dose Level 1
n=3 Participants
Ketamine (Ketalar) Dose Level 1: Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 2
n=3 Participants
Ketamine (Ketalar) Dose Level 2: Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 3
n=3 Participants
Ketamine (Ketalar) Dose Level 3: Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 4
n=3 Participants
Ketamine (Ketalar) Dose Level 4: Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 3.2 • n=93 Participants
|
35.3 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
32.0 years
STANDARD_DEVIATION 3.6 • n=27 Participants
|
33.0 years
STANDARD_DEVIATION 1.7 • n=483 Participants
|
34.3 years
STANDARD_DEVIATION 3.9 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
12 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
9 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
3 participants
n=27 Participants
|
3 participants
n=483 Participants
|
12 participants
n=36 Participants
|
|
Estimated Gestational Age at Delivery
37-weeks
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Estimated Gestational Age at Delivery
38-weeks
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Estimated Gestational Age at Delivery
39-weeks
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
|
Estimated Gestational Age at Delivery
40-weeks
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
History of Anxiety
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
4 Participants
n=36 Participants
|
|
History of Depression
|
2 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
8 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Between 0 to 24 hours postpartumMaximum 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 rate \<40 or \>120). Outcome measure of tolerability and intolerability will be reported as n (%). The MTD was 0.18 mg/kg/hr for one hour, followed by 0.05 mg/kg/hr for 11 hours.
Outcome measures
| Measure |
Ketamine (Ketalar) Dose Level 1
n=3 Participants
Ketamine (Ketalar) Dose Level 1: Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 2
n=3 Participants
Ketamine (Ketalar) Dose Level 2: Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 3
n=3 Participants
Ketamine (Ketalar) Dose Level 3: Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 4
n=3 Participants
Ketamine (Ketalar) Dose Level 4: Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
|---|---|---|---|---|
|
Maximum Tolerated Dose of Ketamine
Tolerability of Dose
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
|
Maximum Tolerated Dose of Ketamine
Intolerability of Dose
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Between 0 to 24-hours postpartumNumber (%) of patient cohort reporting acceptability at each ketamine dose. Patient reported acceptability was recorded from a 21-question survey that reviewed seven common side effects: dizziness, lightheadedness, bad dreams, hallucinations, nausea, vomiting, and itchiness. Unacceptability is defined as patients reporting any of seven side effects as unacceptable.
Outcome measures
| Measure |
Ketamine (Ketalar) Dose Level 1
n=3 Participants
Ketamine (Ketalar) Dose Level 1: Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 2
n=3 Participants
Ketamine (Ketalar) Dose Level 2: Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 3
n=3 Participants
Ketamine (Ketalar) Dose Level 3: Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 4
n=3 Participants
Ketamine (Ketalar) Dose Level 4: Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
|---|---|---|---|---|
|
Patient Reported Acceptability of Any Reported Side Effects
Acceptability of dose side effects
|
3 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Patient Reported Acceptability of Any Reported Side Effects
Unacceptability of dose side effects
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Ketamine (Ketalar) Dose Level 1
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ketamine (Ketalar) Dose Level 2
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ketamine (Ketalar) Dose Level 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Ketamine (Ketalar) Dose Level 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ketamine (Ketalar) Dose Level 1
n=3 participants at risk
Ketamine (Ketalar) Dose Level 1: Loading Dose: 0.05 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 2
n=3 participants at risk
Ketamine (Ketalar) Dose Level 2: Loading Dose: 0.08 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 3
n=3 participants at risk
Ketamine (Ketalar) Dose Level 3: Loading Dose: 0.12 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
Ketamine (Ketalar) Dose Level 4
n=3 participants at risk
Ketamine (Ketalar) Dose Level 4: Loading Dose: 0.18 mg/kg/hr X 1 hour; Maintenance Dose 0.05 mg/kg/hr x 12 hours
|
|---|---|---|---|---|
|
Social circumstances
Side effect: Itchiness
|
100.0%
3/3 • Number of events 18 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
33.3%
1/3 • Number of events 14 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
33.3%
1/3 • Number of events 10 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
33.3%
1/3 • Number of events 4 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
|
Gastrointestinal disorders
Side effect: Nausea/vomiting
|
66.7%
2/3 • Number of events 3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
66.7%
2/3 • Number of events 6 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
66.7%
2/3 • Number of events 2 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
|
Gastrointestinal disorders
Side effect: Dizziness or lightheadedness
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
66.7%
2/3 • Number of events 2 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
33.3%
1/3 • Number of events 1 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
|
Psychiatric disorders
LSD Dysphoria Scale Score
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
66.7%
2/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
|
Psychiatric disorders
Bad Dreams
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
0.00%
0/3 • Adverse event data was collected from time of enrollment (36+ weeks gestation) to 12-weeks postpartum for each enrolled participant.
|
Additional Information
Dr. Katherine Grace Lim, Chief of the Division of OB & Women's Anesthesiology
University of Pittsburgh, UPMC Department of Anesthesiology & Perioperative Medicine
Phone: 412-641-1778
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place