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Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

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ClinicalTrials.gov Identifier: NCT04011592
Recruitment Status : Terminated (Recruitment not feasible)
First Posted : July 8, 2019
Results First Posted : September 14, 2020
Last Update Posted : September 14, 2020
Sponsor:
Information provided by (Responsible Party):
Sudhakar Selvaraj, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE July 3, 2019
First Posted Date  ICMJE July 8, 2019
Results First Submitted Date  ICMJE August 24, 2020
Results First Posted Date  ICMJE September 14, 2020
Last Update Posted Date September 14, 2020
Actual Study Start Date  ICMJE March 4, 2019
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2020)
  • Number of Treatment-Emergent Adverse Events [ Time Frame: 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.
  • 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.
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • Treatment-Emergent Adverse Events [ Time Frame: 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.
  • 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.
  • 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.
  • 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).
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Official Title  ICMJE Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post Partum Depression
Intervention  ICMJE
  • Drug: Ketamine 0.5 mg/kg
    single intravenous infusion of Ketamine (0.5 mg/kg)
    Other Name: Ketamine Hydrochloride
  • Drug: Ketamine 0.2 mg/kg
    single intravenous infusion of Ketamine (0.2 mg/kg)
Study Arms  ICMJE
  • 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)
    Interventions:
    • Drug: Ketamine 0.5 mg/kg
    • Drug: 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)
    Interventions:
    • Drug: Ketamine 0.5 mg/kg
    • Drug: Ketamine 0.2 mg/kg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: August 13, 2020)
1
Original Estimated Enrollment  ICMJE
 (submitted: July 3, 2019)
10
Actual Study Completion Date  ICMJE September 9, 2019
Actual Primary Completion Date September 9, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011592
Other Study ID Numbers  ICMJE HSC-MS-18-0416
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sudhakar Selvaraj, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sudhakar Selvaraj, 713-486-2837 UTHealth Science Center at Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP