Clinical trial NCT04011592: Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Official title: Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Post Partum Depression
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* Not diagnosed with an intellectual disability or neurodegenerative diseases.
* Mothers that are currently breastfeeding.
* No current pregnancy.

Primary outcomes:
measure: Change in Depressed Mood as Indicated by Hamilton Depression Rating Scale (HAM-D) Score
timeFrame: baseline, 24 hours post-injection
Secondary outcomes:
measure: Number of Treatment-Emergent Adverse Events
timeFrame: 24 hours post-injection
measure: Change in Postnatal Depression as Indicated by Edinburgh Postnatal Depression Scale (EPDS) Scale
timeFrame: baseline, 24 hours post-injection
measure: Change in Anxiety as Indicated by Generalized Anxiety Disorder 7-Item (GAD-7) Scale
timeFrame: baseline, 24 hours post-injection
measure: Change in Depression as Indicated by Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, 24 hours post-injection
measure: Change in Behavioral Suicidal Events (Suicidal Ideation), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: baseline, 24 hours post-injection
measure: Change in Behavioral Suicidal Events (Suicidal Behavior), as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: baseline, 24 hours post-injection
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: UTHealth Science Center at Houston
name: Sudhakar Selvaraj, 713-486-2837
role: PRINCIPAL_INVESTIGATOR
References: