Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment not feasible
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg | Experimental | 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 0.2 mg/kg, then Ketamine 0.5 mg/kg | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine 0.5 mg/kg | Drug | single intravenous infusion of Ketamine (0.5 mg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment-Emergent Adverse Events | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sudhakar Selvaraj, 713-486-2837 | UTHealth Science Center at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77054 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Only one participant was enrolled, and this participant received 0.5 mg/kg Ketamine, then 0.2 mg/kg Ketamine.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 24 hours post-injection |
|
24 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketamine 0.5 mg/kg | Ketamine 0.5 mg/kg: single intravenous infusion of Ketamine (0.5 mg/kg) |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild headache | General disorders | Non-systematic Assessment |
Only one subject was enrolled, and enrollment goal not met.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sudhakar Selvaraj, MD, PhD, Assistant Professor | The University of Texas Health Science Center at Houston | 713-486-2837 | Sudhakar.Selvaraj@uth.tmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 26, 2019 | Aug 24, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ketamine 0.2 mg/kg | Drug | single intravenous infusion of Ketamine (0.2 mg/kg) |
|
| 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. | 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. | 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). | 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. | baseline, 24 hours post-injection |
| BG001 |
| 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) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Secondary | Number of Treatment-Emergent Adverse Events | Posted | Number | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | This outcome measure was not assessed and no data were collected. | Posted | 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). | This outcome measure was not assessed and no data were collected. | Posted | 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. | This outcome measure was not assessed and no data were collected. | Posted | baseline, 24 hours post-injection |
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Ketamine 0.2 mg/kg | Ketamine 0.2 mg/kg: single intravenous infusion of Ketamine (0.2 mg/kg) | 0 | 1 | 0 | 1 | 1 | 1 |
| Moderate Nausea | General disorders | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |