Clinical TrialKetaminePlaceboCompleted

Ketamine Infusion for Social Anxiety Disorder

* Social Anxiety Disorder (SAD) is common and causes significant impairment. * First-line treatments for Social Anxiety Disorder are only partially effective. Many SAD patients experience little or inadequate symptom relief with available treatments. * Ketamine is a potent NMDA receptor antagonist. Ketamine represents an agent with a potentially novel mechanism of action for the treatment of anxiety disorders. * Ketamine has demonstrated efficacy in the treatment of psychiatric disorders closely related to Social Anxiety Disorder including Major Depression, Bipolar Depression and possibly Obsessive-Compulsive Disorder. Ketamine represents the possibility to provide rapid symptom relief to patients with SAD and may provide the mechanism for future drug development to treat SAD more rapidly and effectively.

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

Study Arms & Interventions

Ketamine

experimental

Intravenous ketamine infusion (0.5 mg/kg over 40 min)

Interventions

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

    administered over 40 min

Placebo

placebo

Intravenous normal saline infusion

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    normal saline

Primary Results(1 publication)

Participants

N = 36Mean age: 29.72 across armsH. et al. 2017 →

Adverse Events (from all publications)

Arm / GroupnAny TEAESevereSeriousDiscont.
Ketamineexperimental1817(94.4%)0(0.0%)0(0.0%)0(0.0%)
Placeboplacebo175(29.4%)0(0.0%)0(0.0%)0(0.0%)

* Participants experiencing ≥1 TEAE and TEAEs of special interest (dissociative side effects) are based on a Clinician Administered Dissociative States Scale (CADSS) score > 0. All reported side effects resolved within 2h of infusion completion.

* Participants experiencing ≥1 TEAE and TEAEs of special interest (dissociative side effects) are based on a Clinician Administered Dissociative States Scale (CADSS) score > 0. All reported side effects resolved within 2h of infusion completion. One participant did not receive the placebo infusion due to moving out of state, not due to a TEAE.

Study Details

  • Status
    Completed
  • Phase
    Phase I
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment18 participants
  • Timeline
    Start: 2015-01-02
    End: 2016-09-27
  • Compounds
    KetaminePlacebo

Related Publications

Ketamine for Social Anxiety Disorder: A Randomized, Placebo-Controlled Crossover Trial

Published
Authors
Taylor, J. H., Landeros-Weisenberger, A., Coughlin, C., Mulqueen, J., Johnson, J. A., Gabriel, D., Reed, M. O., Jakubovski, E., Bloch, M. H.

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Ketamine Infusion for Social Anxiety Disorder — Clinical Trial Details | Blossom