TerminatedPhase 2Results posted

Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

NCT04011592 · The University of Texas Health Science Center, Houston

Closed to entry

Status

Not accepting participants

Phase 2

Phase

Target enrolment

Study sites

1 US states

What it is testing

Summary

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score
Measured over baseline, 24 hours post-injection

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 45 Years

Ages

FEMALE

Sex

Not accepted

Healthy volunteers

Inclusion Criteria: * 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. * Patients that can speak and read the English language, are able to understand the study procedures and sign the informed consent Exclusion Criteria: * 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. * Not diagnosed with cardiovascular disorders. * No increased risk of laryngospasm or active upper respiratory infections. * Not diagnosed with an intellectual disability or neurodegenerative diseases. * Mothers that are currently breastfeeding. * No current pregnancy.

Where

1 study site

Facility	City	Region	Country
The University of Texas Health Science Center at Houston	Houston	Texas	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT04011592 on ClinicalTrials.gov →

Last updated in the registry 2021-10-19. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Recruiting in

Texas71

All 6 trials from The University of Texas Health Science Center, Houston →