Clinical TrialKetamineCompleted

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 IV• three times weekly• 6 doses total

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

Primary Results(1 publication)

Participants

N = 77Mean age: 34.6 across armsW. et al. 2019 →

MADRS

Score at Timepoint

Six ketamine infusions—Day 13·W. et al. 2019 →

Response Rates

≥50% reduction from baseline MADRS total score

10/77(13.0%)·W. et al. 2019 →
52/77(67.5%)·W. et al. 2019 →

MADRS total score ≤10 (remission)

6/77(7.8%)·W. et al. 2019 →
37/77(48.1%)·W. et al. 2019 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Six ketamine infusionsexperimental77———9(11.7%)

* Discontinuation (n=9) was due to lack of time (n=1), suicidal behavior (n=1), inefficacy (n=3), and withdrawal of consent (n=4). The paper notes psychotomimetic and dissociative symptoms were generally mild and well tolerated.

Study Details

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

Related Publications

Investigation of medical effect of multiple ketamine infusions on patients with major depressive disorder

Published
Authors
Zheng, W., Zhou, Y-L., Wang, C-Y.

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