Clinical TrialAnxiety DisordersKetamineNot yet recruiting

Evaluation of brain glutamatergic mechanisms in patients with treatment resistant anxiety - comparative effects of ketamine vs fentanyl

This randomised controlled parallel group Phase I trial (n=40) evaluated the safety and efficacy of ketamine for anxiety using 70mg/70kg ketamine.

Target Enrollment
40 participants
Study Type
Phase I interventional
Design
Randomized, quadruple Blind

Detailed Description

Low-dose ketamine has fast-acting positive effects on mood in patients with treatment resistant anxiety, similar to its effects in depression. This is a mechanistic study to assess changes in brain function in patients with treatment resistant anxiety treated with ketamine or a psychoactive control, using a range of assessment methods (brain imaging, EEG analysis, blood pharmacokinetic samples). Data from this study may help clarify the neurobiological basis of treatment-resistant anxiety.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine

Participants

Inclusion Criteria

  • Male or female aged 18-65y
  • Diagnosed with DSM-5 Generalized Anxiety Disorder and/or Social Anxiety Disorder, with inadequate response to prior treatment i.e. unsuccessful with 1 or more prescribed antidepressants and prior failed psychotherapy
  • Hamilton Anxiety Scale (HAM-A) score of >20, and/or a Liebowitz Social Anxiety Scale (LSAS) score of >60 at screening.
  • Prior response to ketamine as demonstrated by a >50% decrease in HAMA and/or Fear Questionnaire (FQ) scores 24 hours after dosing.

Exclusion Criteria

  • evidence of severe acute or chronic medical disorders,
  • presence of implanted cardiac pacemakers, hearing aids, insulin pumps or neurostimulators; intracranial metal clips; or metallic bodies in the eye
  • past or current diagnoses of schizophrenia, bipolar disorder, or current psychotic symptoms
  • female patients who are pregnant or lactating
  • drug abuse or dependence in the last 6 months
  • current significant suicidal ideation
  • current Major Depressive Disorder (MADRS >20 at screening).
  • participants must be free of recreational drug and alcohol use at the time of testing

Study Details

  • Status
    Not yet recruiting
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment40 participants
  • Timeline
    Start: 2017-10-01
    End: 2019-10-01
  • Compound
    Ketamine
  • Topic
    Anxiety Disorders

Locations

Unknown facility — Australia

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