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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04011592
Other study ID # HSC-MS-18-0416
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date March 4, 2019
Est. completion date September 9, 2019

Study information

Verified date September 2021
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date September 9, 2019
Est. primary completion date September 9, 2019
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Drug:
Ketamine 0.5 mg/kg
single intravenous infusion of Ketamine (0.5 mg/kg)
Ketamine 0.2 mg/kg
single intravenous infusion of Ketamine (0.2 mg/kg)

Locations

Country Name City State
United States The University of Texas Health Science Center at Houston Houston Texas

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. baseline, 24 hours post-injection
Secondary Number of Treatment-Emergent Adverse Events 24 hours post-injection
Secondary 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. baseline, 24 hours post-injection
Secondary 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. baseline, 24 hours post-injection
Secondary 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. baseline, 24 hours post-injection
Secondary 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). baseline, 24 hours post-injection
Secondary 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. baseline, 24 hours post-injection
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