Post Partum Depression
Conditions
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.
Interventions
DRUGKetamine 0.5 mg/kg
single intravenous infusion of Ketamine (0.5 mg/kg)
single intravenous infusion of Ketamine (0.2 mg/kg)
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale | 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 | 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. |
| Number of Treatment-Emergent Adverse Events | 24 hours post-injection | — |
| Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | 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) | 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. |
| Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9) | baseline, 24 hours post-injection | The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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)
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) | 1 |
| 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)
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) | 0 |
| Total | 1 |
Baseline characteristics
| Characteristic | Total | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg |
|---|---|---|---|
| Age, Continuous | 37 years | 37 years | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 0 Participants |
| Region of Enrollment United States | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 1 / 1 | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
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.
Time frame: baseline, 24 hours post-injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine 0.5 mg/kg | Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score | 9 score on a scale |
| Ketamine 0.2 mg/kg | Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score | 3 score on a scale |
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.
Time frame: baseline, 24 hours post-injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine 0.5 mg/kg | Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale | 5 score on a scale |
| Ketamine 0.2 mg/kg | Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale | 0 score on a scale |
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.
Time frame: baseline, 24 hours post-injection
Population: This outcome measure was not assessed and no data were collected.
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).
Time frame: baseline, 24 hours post-injection
Population: This outcome measure was not assessed and no data were collected.
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.
Time frame: baseline, 24 hours post-injection
Population: This outcome measure was not assessed and no data were collected.
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.
Time frame: baseline, 24 hours post-injection
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ketamine 0.5 mg/kg | Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale | 8 score on a scale |
| Ketamine 0.2 mg/kg | Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale | 2 score on a scale |
Secondary
Number of Treatment-Emergent Adverse Events
Time frame: 24 hours post-injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ketamine 0.5 mg/kg | Number of Treatment-Emergent Adverse Events | mild headache | 1 adverse events |
| Ketamine 0.5 mg/kg | Number of Treatment-Emergent Adverse Events | moderate nausea | 1 adverse events |
| Ketamine 0.2 mg/kg | Number of Treatment-Emergent Adverse Events | mild headache | 1 adverse events |
| Ketamine 0.2 mg/kg | Number of Treatment-Emergent Adverse Events | moderate nausea | 0 adverse events |