Clinical TrialKetamineCompleted

Open-Label IV Ketamine Series for MDD/Bipolar Depression with Pain Mediation Analysis (Wu 2023, China)

Open-label single-arm clinical trial (J Affect Disord 2023; Wu Z, Gan Y, Li N, Lan X, Wang C; single centre, China; PMID 37156269). Participants: n≈122 enrolled adults with DSM-5 MDD or bipolar depression who failed ≥2 antidepressant trials or had suicidal ideation; exclusions: alcohol/drug dependence, recent mania/hypomania, unstable medical findings. All received 6 IV ketamine hydrochloride infusions (0.5 mg/kg over 40 min) on a Mon–Wed–Fri schedule over 2 weeks; concomitant psychotropics permitted but dose-stable. Analytic sample: n=103 completers at baseline and day 13; 19 participants (18.4%) did not complete day 26 follow-up. Primary outcomes: MADRS, SDS (social/occupational/home domains), GAF; pain assessed by SF-MPQ (sensory, affective, present pain intensity indices) at baseline, day 13, day 26. CT.gov: 0 hits; PubMed DataBankList: empty; no registration number in methods.

Target Enrollment
122 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Ketamine

experimental

6 intravenous infusions of ketamine (0.5 mg/kg) over 2 weeks

Interventions

  • Ketamine0.5 mg/kg
    via IV• repeated infusions• 6 doses total

    Administered via intravenous pump with 0.9% sodium chloride injection over 40 min; infusions occurred Monday, Wednesday, and Friday over a two-week period.

Primary Results(1 publication)

Participants

N = 103Mean age: 34.3 across armsZ. et al. 2023 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Ketamineexperimental103————

* The paper does not report summary counts for treatment-emergent adverse events (TEAEs), severe AEs, serious AEs, discontinuations due to AEs, or serious adverse events of special interest (SAESIs). The total number of participants (n=103) is used as nAtRisk, as all received ketamine infusions. Monitoring of vital signs during and after injection was mentioned, but no adverse event data was provided.

Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment122 participants
  • Timeline
    Start: 2020-01-01
    End: 2022-01-01
  • Compound
    Ketamine

Related Publications

Pain mediates the improvement of social functions of repeated intravenous ketamine in patients with unipolar and bipolar depression

Published
Authors
Wu, Z., Gan, Y., Li, N., Lan, X., Wang, C., Zhang, F., Liu, H., Li, W., Ye, Y., Hu, Z., Ning, Y., Zhou, Y.

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