NCT04011592

Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Post Partum Depression

Interventions

Type	Name	Description
DRUG	Ketamine 0.5 mg/kg	single intravenous infusion of Ketamine (0.5 mg/kg)
DRUG	Ketamine 0.2 mg/kg	single intravenous infusion of Ketamine (0.2 mg/kg)

Timeline

• Start date: 2019-03-04
• Primary completion: 2019-09-09
• Completion: 2019-09-09
• First posted: 2019-07-08
• Last updated: 2021-10-19
• Results posted: 2020-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study