Clinical TrialAnxiety DisordersKetamineCompleted

Effect of ketamine on anxiety ratings in patients with anxiety disorders

This non-randomised trial (n=25) investigates the effects of ketamine on anxiety ratings in patients with anxiety disorders, specifically Generalized Anxiety Disorder (GAD) or Social Phobia (SP).

Target Enrollment
25 participants
Study Type
Phase I/II interventional
Design
Non-randomized, single Blind

Detailed Description

Phases 1–2 evaluate within-subject ascending single subcutaneous ketamine doses (0.25, 0.5, 1 mg/kg) with ~1 week between doses; Phase 1 open‑label, Phase 2 double‑blind with midazolam active control.

Phase 3 offers maintenance ketamine (1–2× weekly for up to 3 months) to participants achieving ≥50% reduction in anxiety. Outcomes include change in HAM‑A/SSAI/LSAS at predose, 1h, 2h, 24h (primary), 72h and 168h; safety via vital signs and monitoring up to 24h post-dose.

Study Protocol

Preparation

sessions

Dosing

3 sessions

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Within-subject ascending single doses of ketamine (0.25→1 mg/kg SC) with ~1 week between doses; responders may enter Phase 3 maintenance.

Interventions

  • Ketamine0.25 - 1 mg/kg
    via Other• single dose• 3 doses total

    Subcutaneous (SC) administration; ascending single doses 0.25, 0.5, 1 mg/kg ~1 week apart. Phase 3 maintenance 1–2× weekly up to 3 months for responders (individualised dose).

Midazolam

active comparator

Double-blind active control (midazolam 0.01 mg/kg SC) used in Phase 2; timing randomized within ascending ketamine doses.

Interventions

  • Compound0.01 mg/kg
    via Other• single dose

    Subcutaneous (SC) active control; administered randomized within ascending ketamine doses in Phase 2.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion Criteria

  • GAD patients must have a Hamilton Anxiety Scale (HAM-A) score >20
  • SP patients must have a Liebowitz Social Anxiety Scale (LSAS) self-report score >50.

Exclusion Criteria

  • 1. Female patients who are or intend to become pregnant, or are lactating
  • 2. Participants who, in the opinion of the investigator, do not understand the information and procedures of the study, or would not be compliant with them (in particular the study restrictions and risks involved).
  • 3. Any participant for whom the investigator believes, for any reason, that participation would not be an acceptable risk.
  • 4. Current use of MAOIs, thyroxine or stimulants (amphetamine/methylphenidate). Use of antidepressants or other anxiolytics at stable doses >4 weeks is acceptable.
  • 5. Patients with severe acute or chronic medical illnesses.
  • 6. Patients with current active suicidal ideation.

Study Details

  • Status
    Completed
  • Phase
    Phase IPhase II
  • Type
    interventional
  • Design
    Non-randomizedsingle Blind
  • Target Enrollment25 participants
  • Timeline
    Start: 2015-11-10
    End: 2017-12-15
  • Compound
    Ketamine
  • Topic
    Anxiety Disorders

Locations

Unknown facility — Australia

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