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NCT04011592 · ClinicalTrials.gov registry record · Phase 2
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
A Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
- Terminated
- Registry status
- Phase 2
- Development phase
- 1
- Enrollment target
NCT04011592: Clinical Trial Phase 2 study, sponsored by The University of Texas Health Science Center, Houston.
NCT04011592 is a Phase 2 study that was terminated before completion, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 1 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04011592, a Phase 2 study, was terminated before completion, sponsored by The University of Texas Health Science Center, Houston.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 1 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Ketamine 0.5 mg/kg
- DRUG Ketamine 0.2 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2019-03-04 |
| Est. Completion | 2019-09-09 |
| Phase | Phase 2 |
Why NCT04011592 stopped before completion
NCT04011592 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Ketamine 0.5 mg/kg is the first listed.
NCT04011592 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04011592 about?
NCT04011592 is a clinical study titled "Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression". 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 dimin...
What is the current status of trial NCT04011592?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2019-03-04. Estimated completion is 2019-09-09.
What interventions are being tested in trial NCT04011592?
The interventions under investigation include: Ketamine 0.5 mg/kg (DRUG), Ketamine 0.2 mg/kg (DRUG).
Who is sponsoring clinical trial NCT04011592?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04011592's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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