Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

Ketamine

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.

Intervention / Treatment

  • Ketamine 0.5 mg/kg (DRUG)
    single intravenous infusion of Ketamine (0.5 mg/kg)
  • Ketamine 0.2 mg/kg (DRUG)
    single intravenous infusion of Ketamine (0.2 mg/kg)

Condition or Disease

  • Post Partum Depression

Phase

  • Phase 2

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 45 Years
    Enrollment: 1 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Mar 04, 2019 ACTUAL
    Primary Completion: Sep 09, 2019 ACTUAL
    Completion Date: Sep 09, 2019 ACTUAL
    Study First Posted: Jul 08, 2019 ACTUAL
    Results First Posted: Sep 14, 2020 ACTUAL
    Last Updated: Sep 29, 2021

    Sponsors / Collaborators

    Lead Sponsor: The University of Texas Health Science Center, Houston
    Responsible Party: Sudhakar Selvaraj

    Location

    Houston, Texas, USA

    Participant Groups

    • 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)

    Eligibility Criteria

    Sex: Female
    Minimum Age: 18
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes

    • 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 Outcomes
    • Number of Treatment-Emergent Adverse Events 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.

    • 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.

    • The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.

    • 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).

    • 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.

    More Details

    NCT Number: NCT04011592
    Other IDs: HSC-MS-18-0416
    Study URL: https://clinicaltrials.gov/study/NCT04011592
    Last updated: Sep 29, 2023