Clinical TrialKetamineKetamineKetaminePlaceboCompleted

Ascending-Dose Subcutaneous Ketamine for Treatment-Refractory Anxiety Disorders: Dose-Finding Study (Glue 2017, University of Otago, ANZCTR)

Prospective within-subject ascending-dose study (J Psychopharmacol 2017; Glue P, Medlicott NJ, Harland S, Neehoff S, Anderson-Fahey B, Le Nedelec M, Gray A, McNaughton N; University of Otago, Dunedin, New Zealand; DOI 10.1177/0269881117705089). Registered with the Australian New Zealand Clinical Trial Registry (ANZCTR); number not reported in extracted methods text, PubMed DataBankList, or CrossRef. Participants: 12 adults (4 male, 8 female; mean age 31 yr) with treatment-refractory DSM-IV GAD and/or SAD (HAM-A ≥20 and/or LSAS ≥60; failed ≥2 antidepressant courses; MADRS <20). No control arm (within-subject design). Intervention: subcutaneous ketamine at three ascending dose levels (0.25, 0.5, 1.0 mg/kg) plus an active control (midazolam 0.01 mg/kg) administered once weekly; doses given in fixed ascending order with midazolam randomly inserted. Participants continued stable ongoing medications. Primary outcomes: HAM-A and Fear Questionnaire (FQ). Companion papers: anxiety symptoms (Glue P et al. J Psychopharmacol 2017) and EEG (Glue P et al. Int J Neuropsychopharmacol 2018, PMID 29718262).

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Target Enrollment
12 participants
Study Type
interventional
Design
Non-randomized

Study Arms & Interventions

Ketamine 0.25mg/kg

experimental

Subcutaneous administration of 0.25 mg/kg ketamine

Interventions

  • Ketamine0.25 mg/kg
    via Subcutaneous• single dose• 1 doses total

    Administered at 1-week intervals in an ascending dose design

Ketamine 0.5mg/kg

experimental

Subcutaneous administration of 0.5 mg/kg ketamine

Interventions

  • Ketamine0.5 mg/kg
    via Subcutaneous• single dose• 1 doses total

    Administered at 1-week intervals in an ascending dose design

Ketamine 1mg/kg

experimental

Subcutaneous administration of 1 mg/kg ketamine

Interventions

  • Ketamine1 mg/kg
    via Subcutaneous• single dose• 1 doses total

    Administered at 1-week intervals in an ascending dose design

Midazolam 0.01mg/kg

active comparator

Subcutaneous administration of 0.01 mg/kg midazolam as an active control

Interventions

  • Placebo0.01 mg/kg
    via subcutaneous• single dose• 1 doses total

    Counterbalanced in dosing position across patients

Study Protocol, Arms & Participants

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Study Details

  • Status
    Completed
  • Type
    interventional
  • Design
    Non-randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2015-01-01
    End: 2017-01-01
  • Compounds
    KetamineKetamineKetaminePlacebo

Related Publications

Open AccessindividualSecondary analysis

Ketamine’s dose-related effects on anxiety symptoms in patients with treatment refractory anxiety disorders

This ascending single-dose study (n=12) evaluates the dose-related effects of ketamine (18-70mg/70kg) on patients with anxiety symptoms with treatment-resistant anxiety disorders. Ten of the twelve participants (83%) found relief for up to seven days. The results support ketamine as a potential therapeutic alternative for patients with anxiety disorders.

Published
Journal
Journal of Psychopharmacology
Authors
Glue, P., Medlicott, N. J., Harland, S., Neehoff, S., Anderson-Fahey, B., Le Nedelec, M., Gray, A., Mcnaughton, N.
Open AccessindividualPrimary

Ketamine Effects on EEG during Therapy of Treatment-Resistant Generalized Anxiety and Social Anxiety

This randomised, double-blind, active placebo-controlled study (n=12) investigated the effects of 3 ascending ketamine dose levels (17.5/35/70mg/70kg) and midazolam (0.7mg/70kg) on electrophysiological brain activity in patients with anxiety. While ketamine increased high-frequency brain rhythms and decreased low-frequency rhythms in a dose-dependent manner, only decreases within the frontal theta frequency band were related to improvements in anxiety.

Published
Journal
International Journal of Neuropsychopharmacology
Authors
Shadli, S. M., Kawe, T., Martin, D., McNaughton, N., Neehoff, S., Glue, P.

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