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NMDA Receptor Antagonist
Ketamine for Postpartum Depression
Phase 1
Recruiting
Led By Grace Lim, MD, MSc
Research Sponsored by Grace Lim, MD, MS
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Neuraxial anesthesia with neuraxial morphine
American Society of Anesthesiologists Physical Status of 2 or 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between 0 to 24 hours postpartum
Awards & highlights
Study Summary
This trial tests a safe ketamine dose for postpartum women after c-section in order to minimize side effects.
Who is the study for?
This trial is for adults over 18 who've had a cesarean delivery under specific anesthesia, are in good health (ASA PS 2 or 3), and have delivered at term. It's open to those not breastfeeding or using ketamine clinically. Exclusions include general anesthesia, allergies to study drugs, severe health issues, certain medical histories like drug abuse or psychosis.Check my eligibility
What is being tested?
The study aims to find a tolerable dose of ketamine for postpartum depression and pain after cesarean delivery. Participants will receive varying levels of ketamine as an infusion with the focus on determining the maximum tolerated dose without significant side effects.See study design
What are the potential side effects?
Ketamine may cause side effects during the loading dose such as nausea, dizziness, disorientation, elevated blood pressure and heart rate changes. Long-term psychological effects are possible but considered less likely at subanesthetic doses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received spinal anesthesia with morphine.
Select...
I have a mild to severe systemic disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ between 0 to 24-hours postpartum
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between 0 to 24-hours postpartum
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum Tolerated Dose of ketamine
Secondary outcome measures
Patient reported acceptability of any reported side effects
Trial Design
1Treatment groups
Experimental Treatment
Group I: Loading dose KetamineExperimental Treatment4 Interventions
Loading dose of ketamine in 3+3 MTD for 1 hour followed by maintenance 0.05mg/kg/hr ketamine 11-hour infusion.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Grace Lim, MD, MSLead Sponsor
8 Previous Clinical Trials
599 Total Patients Enrolled
2 Trials studying Postpartum Depression
14 Patients Enrolled for Postpartum Depression
National Institute of Mental Health (NIMH)NIH
2,786 Previous Clinical Trials
2,689,697 Total Patients Enrolled
25 Trials studying Postpartum Depression
8,143 Patients Enrolled for Postpartum Depression
Grace Lim, MD, MScPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I will undergo surgery with general anesthesia.You are allergic to the medications being used in the study.My blood pressure and heart rate are stable.I have received spinal anesthesia with morphine.I have never abused ketamine or PCP, and I don't have schizophrenia, psychosis, liver or kidney issues, uncontrolled high blood pressure, chest pain, arrhythmia, head trauma, high brain pressure, or uncontrolled thyroid disease.You have severe health problems that affect your daily activities.You were born before 37 weeks of pregnancy.If you have had a cesarean delivery, you cannot participate.You have a condition called hypertensive disorder of pregnancy.I cannot have spinal or epidural anesthesia due to health reasons.Expecting the need for special medical care for the baby after birth.You have a severe form of pre-eclampsia.I am 18 years old or older.I have a mild to severe systemic disease.You have been pregnant for at least 37 weeks.I am not planning to breastfeed, or I am receiving ketamine for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Loading dose Ketamine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still vacancies for this experiment that participants can join?
"The data hosted on clinicaltrials.gov reveals that this specific trial is not presently enrolling participants, despite the fact it was originally posted in September 1st 2023 and last updated 6th of July 2023. Nevertheless, there are currently 1866 other studies searching for candidates."
Answered by AI
What evidence exists concerning the security of administering an initial dose of ketamine to patients?
"Our team at Power gave Loading dose Ketamine a rating of 1, as this is only in the early stages of clinical research with limited data collected to evaluate safety and efficacy."
Answered by AI
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