Clinical TrialPostpartum DepressionKetamineKetamineTerminated

Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

Randomised, crossover Phase II study (n=1) testing single IV ketamine infusions 0.5 mg/kg and 0.2 mg/kg in postpartum depression to assess safety, pharmacokinetics and antidepressant efficacy.

Target Enrollment
1 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

This randomised, two-period crossover Phase II trial evaluates single intravenous ketamine infusions (0.5 mg/kg and 0.2 mg/kg) in participants with postpartum depression with a 7-day washout between sessions.

Primary objectives are safety and pharmacokinetics; antidepressant efficacy is assessed using standard rating scales (EPDS, HAM-D) with eligibility requiring moderate to severe symptoms and stability of concomitant antidepressant treatment.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

Ketamine crossover

experimental

Randomised two-period crossover of single IV ketamine infusions (0.5 mg/kg and 0.2 mg/kg) with a 7-day washout; participants receive both doses in counterbalanced order.

Interventions

  • Ketamine0.5 mg/kg
    via IV• single dose

    Single intravenous infusion 0.5 mg/kg; 7-day washout between sessions

  • Ketamine0.2 mg/kg
    via IV• single dose

    Single intravenous infusion 0.2 mg/kg; 7-day washout between sessions

Participants

Ages
18 – 45
Sexes
Male & Female

Inclusion 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
  • Maintain stable dose of antidepressants while enrolled
  • Able to speak and read English, understand procedures and sign informed consent

Exclusion Criteria

  • 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

Study Details

  • Status
    Terminated
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment1 participants
  • Timeline
    Start: 2019-04-03
    End: 2019-09-09
  • Compounds
    KetamineKetamine
  • Topic
    Postpartum Depression

Locations

The University of Texas Health Science Center at Houston — Houston, Texas, United States

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