Suspended

Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Ketamine 0.5 mg/kg

+ Ketamine 0.2 mg/kg

Drug
Who is being recruted

Urogenital Diseases+5

+ Mental Disorders

+ Depressive Disorder

From 18 to 45 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: March 2019
See protocol details

Summary

Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 4, 2019

Actual date on which the first participant was enrolled.

Postpartum depression is a non-psychotic major or minor depressive episode that occurs during pregnancy or within 12 months of post-partum period. The nature of symptoms is same as depressive episode characterized by depressed mood, anxiety, sleep difficulties, suicidal thoughts, tiredness and diminished interest in pleasurable activities. Severe maternal depression affects children by increasing the risk of emotional and behavioral and physical health problems and cognitive difficulties. Thus early screening and intervention is critical in reducing the negative impact of PND in the mother and child, family and the community. The purpose of this study is to assess the safety, pharmacokinetics and antidepressant efficacy of sub-anesthetic dose of intravenous ketamine in perinatal depression.

Official TitleEfficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
NCT04011592
Principal SponsorThe University of Texas Health Science Center, Houston
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1 patient to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 45 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesMental DisordersDepressive DisorderFemale Urogenital Diseases and Pregnancy ComplicationsPregnancy ComplicationsPuerperal DisordersDepression, PostpartumMood Disorders

Criteria

5 inclusion criteria required to participate
Female subjects, ages 18-45 years
Experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery and with moderate or severe symptoms (>12 EPDS or >14 HAM-D).
No or partial response to adequate doses of SSRI medications to treat PND for longer than 6 weeks.
PND patients will be requested to maintain the stable dose of antidepressants while enrolled in the study trial.
Show More Criteria
9 exclusion criteria prevent from participating
No current or past psychosis or severe personality disorder.
No current substance abuse or dependence.
No serious and imminent suicidal or homicidal risk.
No recent or history of major and unstable medical problems that affect brain anatomy, neurochemistry, or function.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
single intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg)

Group II

Experimental
single intravenous infusion of Ketamine (0.5 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.2 mg/kg)

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

The University of Texas Health Science Center at Houston

Houston, United StatesOpen The University of Texas Health Science Center at Houston in Google Maps
SuspendedOne Study Center