Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

The University of Texas System (UT)

Status and phase: Terminated; Phase 2

Conditions: Post Partum Depression

Treatments: Drug: Ketamine 0.5 mg/kg; Drug: Ketamine 0.2 mg/kg

Study type: Interventional

Funder types: Other

Identifiers

NCT04011592

HSC-MS-18-0416

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups

Ketamine 0.5 mg/kg, then Ketamine 0.2 mg/kg

Experimental group

Description:

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)

Treatment:

Drug: Ketamine 0.2 mg/kg

Drug: Ketamine 0.5 mg/kg

Ketamine 0.2 mg/kg, then Ketamine 0.5 mg/kg

Experimental group

Description:

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)

Treatment:

Drug: Ketamine 0.2 mg/kg

Drug: Ketamine 0.5 mg/kg