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Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

Primary Purpose

Post Partum Depression

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ketamine 0.5 mg/kg
Ketamine 0.2 mg/kg
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Depression

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept 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.

Sites / Locations

  • The University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm Description

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

Outcomes

Primary Outcome Measures

Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score
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.

Secondary Outcome Measures

Number of Treatment-Emergent Adverse Events
Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale
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.
Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale
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.
Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.
Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
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).
Change in Behavioral Suicidal Events (Suicidal Behavior), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
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.

Full Information

First Posted
July 3, 2019
Last Updated
September 29, 2021
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04011592
Brief Title
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Official Title
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Recruitment not feasible
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
September 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg
Arm Type
Experimental
Arm Description
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)
Arm Title
Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.5 mg/kg
Other Intervention Name(s)
Ketamine Hydrochloride
Intervention Description
single intravenous infusion of Ketamine (0.5 mg/kg)
Intervention Type
Drug
Intervention Name(s)
Ketamine 0.2 mg/kg
Intervention Description
single intravenous infusion of Ketamine (0.2 mg/kg)
Primary Outcome Measure Information:
Title
Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score
Description
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.
Time Frame
baseline, 24 hours post-injection
Secondary Outcome Measure Information:
Title
Number of Treatment-Emergent Adverse Events
Time Frame
24 hours post-injection
Title
Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale
Description
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.
Time Frame
baseline, 24 hours post-injection
Title
Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Description
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.
Time Frame
baseline, 24 hours post-injection
Title
Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)
Description
The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.
Time Frame
baseline, 24 hours post-injection
Title
Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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).
Time Frame
baseline, 24 hours post-injection
Title
Change in Behavioral Suicidal Events (Suicidal Behavior), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Description
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.
Time Frame
baseline, 24 hours post-injection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudhakar Selvaraj, 713-486-2837
Organizational Affiliation
UTHealth Science Center at Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

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