Clinical TrialSingle-armKetamineCompleted

Multiple IV Ketamine Infusions for Major Depressive Disorder: Open-Label Study (Zheng 2019, Guangzhou Brain Hospital)

Open-label single-arm clinical study (J Psychopharmacol 2019 Apr; Zheng W, Zhou YL, Liu WJ, Wang CY; Affiliated Brain Hospital of Guangzhou Medical University, China; PMID 30789302). Enrolled Nov 2016 – Dec 2017. Participants: adults 18–65 with DSM-5 MDD (confirmed by two psychiatrists), HAMD-17 ≥17, and either suicidal ideation (SSI-part 1 ≥2) or TRD (≥2 failed adequate antidepressant trials in current episode). No control arm, no randomisation. Intervention: six IV ketamine infusions (0.5 mg/kg in 40 mL saline, 40 min infusion pump) on Mon/Wed/Fri over 12 days; concomitant psychotropics continued at stable dose. Co-primary outcomes: MADRS response (≥50% reduction) and remission (MADRS ≤10) at 24 hours after sixth infusion. ITT analysis with SPSS v.24. Methods state registration in the Chinese Clinical Trial Registry (ChiCTR); registration number not reported in paper text or PubMed XML DataBankList.

Target Enrollment
Not specified
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Six ketamine infusions

experimental

Six consecutive intravenous ketamine infusions administered over 12 days (Monday-Wednesday-Friday).

Interventions

  • Ketamine0.5 mg/kg
    via IVthree times weekly6 doses total

    Infusions administered over 40 minutes; administered over a course of 12 days.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Timeline
    Start: 2016-11-01
    End: 2017-12-01
  • Compound

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