A Phase 2 interventional study of Ketamine 0.5 mg/kg and Ketamine 0.2 mg/kg in Post Partum Depression, sponsored by The University of Texas Health Science Center, Houston. Terminated at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by The University of Texas Health Science Center, Houston · Phase 2, Interventional, and Treatment
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 1 is below the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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)
Drug: Ketamine 0.5 mg/kg · Drug: 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)
Drug: Ketamine 0.5 mg/kg · Drug: Ketamine 0.2 mg/kg
single intravenous infusion of Ketamine (0.5 mg/kg)
Also known as: Ketamine Hydrochloride
single intravenous infusion of Ketamine (0.2 mg/kg)
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
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
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
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
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
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
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
| Milestone | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg |
|---|---|---|
| Started | 1 | 0 |
| Completed | 1 | 0 |
| Not completed | 0 | 0 |
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.
| score on a scale | Ketamine 0.5 mg/kg | Ketamine 0.2 mg/kg |
|---|---|---|
| Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score | 9 ± NA | 3 ± NA |
| adverse events | Ketamine 0.5 mg/kg | Ketamine 0.2 mg/kg |
|---|---|---|
| mild headache | 1 | 1 |
| moderate nausea | 1 | 0 |
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.
| score on a scale | Ketamine 0.5 mg/kg | Ketamine 0.2 mg/kg |
|---|---|---|
| Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale | 8 ± NA | 2 ± NA |
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.
| score on a scale | Ketamine 0.5 mg/kg | Ketamine 0.2 mg/kg |
|---|---|---|
| Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale | 5 ± NA | 0 ± NA |
The Patient Health Questionnaire (PHQ-9) score ranges from 0 to 27, with greater scores indicating more severe depression.
No measurements were reported for this outcome.
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Collected over 24 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketamine 0.5 mg/kg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Ketamine 0.2 mg/kg | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Event | Ketamine 0.5 mg/kg | Ketamine 0.2 mg/kg |
|---|---|---|
| Mild headacheGeneral disorders | 1/1 | 1/1 |
| Moderate NauseaGeneral disorders | 1/1 | 0/1 |
Only one participant was enrolled, and this participant received 0.5 mg/kg Ketamine, then 0.2 mg/kg Ketamine.
| Age, Continuous(years) | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg | Total |
|---|---|---|---|
| Mean | 37 ± NA | — | 37 ± NA |
| Sex: Female, Male(Participants) | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg | Total |
|---|---|---|---|
| Female | 1 | 0 | 1 |
| Male | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 1 | 0 | 1 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg | Total |
|---|---|---|---|
| United States | 1 | 0 | 1 |
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The University of Texas Health Science Center, Houston