Ketamine to Prevent PPD After Cesarean

NCT04227704 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 201910191
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to randomise participants to receive ketamine or placebo control subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to assess the incidence of postpartum depression. This feasibility pilot study is designed to explore the adequacy of the study procedures and tolerability of the interventions.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (4)

• The Prevalence of Postpartum Depression in the Study Population, as Defined as EPDS Greater Than 10 Out of 30

  Establish a sufficient burden of disease (\>10%) in our population to warrant a full RCT

  42 days postpartum

• Percentage of Eligible Patients Consenting to Participation

  Establish a recruitment rate of greater than 50% to confirm the feasibility of conducting an RCT in our population Twenty-five (20.7%) out of 121 women who were approached consented to participation. 2 were withdrawn with 23 completing participation.

  Through study completion, approximately 9 months

• Percentage of Patients With a Complete Dataset

  Ensure that the design of assessments and data collection make it possible to achieve a complete dataset in \>90% of participants

  Through study completion, approximately 9 months

• Number of Patients in Study Arms Experiencing One or More Severe Side Effects

  Ascertain that neither of the chosen routes of administration of ketamine are intolerable to patients, as defined as the incidence of one or more severe side effects experienced by \>10% of participants in that study arm.

  Through study completion, approximately 9 months

Secondary Outcomes (16)

• Dose of Opiate Analgesics Administered

  Intraoperative phase, approximately 2 hours

• Dose of Ketorolac Administered (mg)

  Intraoperative phase, approximately 2 hours

• Prevalence of Intraoperative Hypotension

  Intraoperative phase, approximately 2 hours

• Maximum Intraoperative Pain (NRS)

  Intraoperative phase, approximately 2 hours

• Adverse Effects

  Intraoperative and 2 and 6 hours postoperatively

Study Arms (3)

Control

PLACEBO COMPARATOR

Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride.

Drug: Control

Ketamine SC

EXPERIMENTAL

Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride.

Drug: Ketamine 50 MG/ML; Drug: Control

Ketamine IVI

EXPERIMENTAL

Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.

Drug: Ketamine 50 MG/ML; Drug: Control

Interventions

Ketamine 50 MG/ML DRUG

Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).

Ketamine IVI; Ketamine SC

Control DRUG

Administration of 0.9% Sodium Chloride (N/S)

Control; Ketamine IVI; Ketamine SC

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Term pregnancy
• Age 18-45 years of age
• Scheduled cesarean delivery under neuraxial anesthesia

You may not qualify if:

• ASA classification IV or V
• History of psychotic episodes
• History of allergy to ketamine
• Inability to communicate in English or any other barrier to providing informed consent

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

• Monks DT, Palanisamy A, Jaffer D, Singh PM, Carter E, Lenze S. A randomized feasibility pilot-study of intravenous and subcutaneous administration of ketamine to prevent postpartum depression after planned cesarean delivery under neuraxial anesthesia. BMC Pregnancy Childbirth. 2022 Oct 21;22(1):786. doi: 10.1186/s12884-022-05118-8.

  PMID: 36271352 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. David Monks
• Organization: Washington University School of Medicine

dmonks@wustl.edu

314-323-1845

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The ketamine and placebo study injectates (subcutaneous and intravenous) will be prepared, in way that does not allow differentiation, by pharmacy staff who are otherwise uninvolved in the study. Participants will be allocated to groups using a random sequence generator. The patients, investigators and outcome assessors will remain unaware of their group until data collection is complete for all participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof of Anesthesiology

Model Details: Participants will be randomised to one of three groups (two interventional and one control).

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: January 14, 2020
• Study Start: November 12, 2020
• Primary Completion: August 9, 2021
• Study Completion: August 9, 2021
• Last Updated: January 26, 2023
• Results First Posted: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)