MedDataX Logo

Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

NCT ID: NCT04011592

Last Updated: 2021-10-19

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-04

Study Completion Date

2019-09-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post Partum Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg

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)

Group Type EXPERIMENTAL

Ketamine 0.5 mg/kg

Intervention Type DRUG

single intravenous infusion of Ketamine (0.5 mg/kg)

Ketamine 0.2 mg/kg

Intervention Type DRUG

single intravenous infusion of Ketamine (0.2 mg/kg)

Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg

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 Type EXPERIMENTAL

Ketamine 0.5 mg/kg

Intervention Type DRUG

single intravenous infusion of Ketamine (0.5 mg/kg)

Ketamine 0.2 mg/kg

Intervention Type DRUG

single intravenous infusion of Ketamine (0.2 mg/kg)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketamine 0.5 mg/kg

single intravenous infusion of Ketamine (0.5 mg/kg)

Intervention Type DRUG

Ketamine 0.2 mg/kg

single intravenous infusion of Ketamine (0.2 mg/kg)

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ketamine Hydrochloride

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sudhakar Selvaraj

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sudhakar Selvaraj, 713-486-2837

Role: PRINCIPAL_INVESTIGATOR

UTHealth Science Center at Houston

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSC-MS-18-0416

Identifier Type: -

Identifier Source: org_study_id