Post Partum DepressionPhase 2NCT04011592
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
A Phase 2 study testing Ketamine 0.5 mg/kg and Ketamine 0.2 mg/kg in people with Post Partum Depression, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Post Partum Depression
- What is being tested?
- Ketamine 0.5 mg/kg and Ketamine 0.2 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2019to 9 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- Not diagnosed with an intellectual disability or neurodegenerative diseases.
- Mothers that are currently breastfeeding.
- No current pregnancy.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77054
About this study
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.
- Conditions
- Post Partum Depression
- Being tested
- Ketamine 0.5 mg/kg, Ketamine 0.2 mg/kg
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine 0.5 mg/kgDrug
Also called Ketamine Hydrochloride
single intravenous infusion of Ketamine (0.5 mg/kg)
Ketamine 0.2 mg/kgDrug
single intravenous infusion of Ketamine (0.2 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Ketamine 0.5 mg/kg; Drug: 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) Receives: Drug: Ketamine 0.5 mg/kg; Drug: Ketamine 0.2 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 24 hours post-injection
Secondary outcomes (6)
Number of Treatment-Emergent Adverse Events
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: baseline, 24 hours post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start4 Mar 2019
- Primary completion9 Sep 2019
- Study completion9 Sep 2019
Why it stopped: Recruitment not feasible
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Post Partum DepressionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sudhakar Selvaraj, The University of Texas Health Science Center, Houston
- Investigators
- Sudhakar Selvaraj, 713-486-2837, Principal investigator, UTHealth Science Center at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04011592
- Sponsor's protocol ID
- HSC-MS-18-0416
- Status last verified
- Sep 2021
- First submitted
- 3 Jul 2019
- Last updated
- 19 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
- ClinicalTrials.gov ID
- NCT04011592
- Acronym / sponsor ID
- HSC-MS-18-0416
- Conditions
- Post Partum Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment not feasible
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 4 Mar 2019 (actual)
- Primary completion
- 9 Sep 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 8 Jul 2019 (actual)
- Results
- Posted 14 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg | Experimental | Drug: Ketamine 0.5 mg/kg, Drug: Ketamine 0.2 mg/kgsingle 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 | Drug: Ketamine 0.5 mg/kg, Drug: Ketamine 0.2 mg/kgsingle intravenous infusion of Ketamine (0.2 mg/kg), washout period of seven days, and then single intravenous infusion of Ketamine (0.5 mg/kg) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine 0.5 mg/kgAlso: Ketamine Hydrochloridesingle intravenous infusion of Ketamine (0.5 mg/kg) | Drug | Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg, Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg |
| Ketamine 0.2 mg/kgsingle intravenous infusion of Ketamine (0.2 mg/kg) | Drug | Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg, Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg |
Primary outcome
Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score
Time frame: 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.
6 secondary outcomes
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
Time frame: baseline, 24 hours post-injection
Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale
Time frame: baseline, 24 hours post-injection
Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)
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)
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)
Time frame: baseline, 24 hours post-injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sudhakar Selvaraj, 713-486-2837 principal investigator
UTHealth Science Center at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketamine 0.5 mg/kg and Ketamine 0.2 mg/kg in people with Post Partum Depression, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score (time frame: baseline, 24 hours post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.