Status:
TERMINATED
Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Post Partum Depression
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2019
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04011592
Start Date
March 4 2019
End Date
September 9 2019
Last Update
October 19 2021
Active Locations (1)
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1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77054