Trial · NCT04011592
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
NCT04011592, Phase 2, Terminated, The University of Texas Health Science Center, Houston; results first posted 2020-09-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression. Trials, record NCT04011592. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04011592
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
- NCT number
- NCT04011592
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Conditions
- Post Partum Depression
- Interventions
- Ketamine 0.5 mg/kg, Ketamine 0.2 mg/kg
- First posted
- 2019-07-08
- Last updated
- 2021-10-19
- Results first posted
- 2020-09-14
- Limitations and caveats
- Only one subject was enrolled, and enrollment goal not met.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Number of Treatment-Emergent Adverse Events | 24 hours post-injection | |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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). |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score | baseline, 24 hours post-injection | score on a scale | MEAN | |
| SECONDARY | Number of Treatment-Emergent Adverse Events | 24 hours post-injection | adverse events | NUMBER | |
| SECONDARY | Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale | baseline, 24 hours post-injection | score on a scale | MEAN | |
| SECONDARY | Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale | baseline, 24 hours post-injection | score on a scale | MEAN | |
| SECONDARY | Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9) | baseline, 24 hours post-injection | 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) | baseline, 24 hours post-injection | This outcome measure was not assessed and no data were collected. | ||
| SECONDARY | Change in Behavioral Suicidal Events (Suicidal Behavior), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | baseline, 24 hours post-injection | This outcome measure was not assessed and no data were collected. |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score | Ketamine 0.5 mg/kg | 9 | Standard Deviation NA | score on a scale | |
| Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score | Ketamine 0.2 mg/kg | 3 | Standard Deviation NA | score on a scale | |
| Number of Treatment-Emergent Adverse Events | Ketamine 0.5 mg/kg | mild headache | 1 | adverse events | |
| Number of Treatment-Emergent Adverse Events | Ketamine 0.2 mg/kg | mild headache | 1 | adverse events | |
| Number of Treatment-Emergent Adverse Events | Ketamine 0.5 mg/kg | moderate nausea | 1 | adverse events | |
| Number of Treatment-Emergent Adverse Events | Ketamine 0.2 mg/kg | moderate nausea | 0 | adverse events | |
| Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale | Ketamine 0.5 mg/kg | 8 | Standard Deviation NA | score on a scale | |
| Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale | Ketamine 0.2 mg/kg | 2 | Standard Deviation NA | score on a scale | |
| Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Ketamine 0.5 mg/kg | 5 | Standard Deviation NA | score on a scale | |
| Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale | Ketamine 0.2 mg/kg | 0 | Standard Deviation NA | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | 1 | |
| Overall Study | STARTED | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg | 0 | |
| Overall Study | COMPLETED | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | 1 | |
| Overall Study | COMPLETED | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Ketamine 0.5 mg/kg, Then Ketamine 0.2 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Ketamine 0.2 mg/kg, Then Ketamine 0.5 mg/kg | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Mild headache | General disorders | Ketamine 0.5 mg/kg | 1 | 1 | 1 |
| other | Mild headache | General disorders | Ketamine 0.2 mg/kg | 1 | 1 | 1 |
| other | Moderate Nausea | General disorders | Ketamine 0.5 mg/kg | 1 | 1 | 1 |
| other | Moderate Nausea | General disorders | Ketamine 0.2 mg/kg | 0 | 1 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ketamine 0.5 mg/kg | 0 | 1 |
| Total, all-cause mortality | Ketamine 0.2 mg/kg | 0 | 1 |
| Total, other adverse events | Ketamine 0.5 mg/kg | 1 | 1 |
| Total, other adverse events | Ketamine 0.2 mg/kg | 1 | 1 |
| Total, serious adverse events | Ketamine 0.5 mg/kg | 0 | 1 |
| Total, serious adverse events | Ketamine 0.2 mg/kg | 0 | 1 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ketamine 0.5 mg/kg vs Ketamine 0.2 mg/kg: deaths from any cause | Trial comparisons |
| Ketamine 0.5 mg/kg vs Ketamine 0.2 mg/kg: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04011592
GET https://conductscience.org/api/trials/v1/NCT04011592/registered