- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04011592
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77054
- The University of Texas Health Science Center at Houston
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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)
|
single intravenous infusion of Ketamine (0.5 mg/kg)
Other Names:
single intravenous infusion of Ketamine (0.2 mg/kg)
|
Experimental: 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)
|
single intravenous infusion of Ketamine (0.5 mg/kg)
Other Names:
single intravenous infusion of Ketamine (0.2 mg/kg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score
Time Frame: baseline, 24 hours post-injection
|
The Hamilton Depression Rating Scale (HAM-D) score ranges from 0-53.
A score of 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates at least moderate severity of depressive symptoms.
The value reported is the score at baseline minus the score 24 hours post-injection.
|
baseline, 24 hours post-injection
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Treatment-Emergent Adverse Events
Time Frame: 24 hours post-injection
|
24 hours post-injection
|
|
Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale
Time Frame: baseline, 24 hours post-injection
|
The Edinburgh Postnatal Depression Scale (EPDS) score ranges from 0 to 30.
Higher scores indicate worse outcome, with a score of 10 or greater indicating depression.
The value reported is the score at baseline minus the score at 24 hours post-injection.
|
baseline, 24 hours post-injection
|
Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Time Frame: baseline, 24 hours post-injection
|
The Generalized Anxiety Disorder 7-Item (GAD-7) Scale score ranges from 0 to 21, with higher scores indicating greater anxiety.
The value reported is the score at baseline minus the score 24 hours post-injection.
|
baseline, 24 hours post-injection
|
Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)
Time Frame: baseline, 24 hours post-injection
|
The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.
|
baseline, 24 hours post-injection
|
Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: baseline, 24 hours post-injection
|
The C-SSRS is a suicidal ideation and behavior rating scale with yes/no responses.
The first part (Items 1-5) rates an individual's degree of suicidal ideation on a 0-5 scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors".
The C-SSRS outcomes are categories and have binary responses (yes/no).
Suicidal ideation is considered when the patient responds a "yes" answer at any time during treatment to any one of the five suicidal ideation questions (Categories 1-5) on the C-SSRS.
The sum of the 5 intensity item scores create a total score (range 0 to 25) to represent the intensity rating (higher scores indicate more severe suicidal ideation).
|
baseline, 24 hours post-injection
|
Change in Behavioral Suicidal Events (Suicidal Behavior), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: baseline, 24 hours post-injection
|
The questions 6-10 of the C-SSRS are related to suicidal behavior, and the outcome is a simple yes/no response.
Suicidal behavior occurs if the patient answers a "yes" at any time during treatment to any one of the five suicidal behavior questions (Categories 6-10) on the C-SSRS.
|
baseline, 24 hours post-injection
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sudhakar Selvaraj, 713-486-2837, UTHealth Science Center at Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
- Depression
- Depressive Disorder
- Depression, Postpartum
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- HSC-MS-18-0416
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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