Clinical TrialKetamineNot yet recruiting

Ketamine Plus Exposure Therapy For Post-Traumatic Stress Disorder (PTSD)– Open Label Pilot Study Targeting Anxiety

This open-label Phase I trial (n=12) evaluated the safety and efficacy of ketamine for post-traumatic stress disorder using 35mg/70kg ketamine.

Target Enrollment
12 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

This is an open-label feasibility study to assess the acceptability of using combined oral ketamine (K) and prolonger exposure (PE) psychotherapy in patients with Post-Traumatic Stress Disorder. We hypothesize that treatment with oral ketamine in week 1 will reduce distress and fear in most participants, and make participation in PE during weeks 2-11 much easier. We anticipate that some patients completing K+PE will have complete resolution of their PTSD symptoms.

Study Arms & Interventions

Experimental Arm

experimental

Interventions

  • Ketamine

Participants

Inclusion Criteria

  • Male or female aged between 18 and 50 years
  • Capable of understanding and signing an informed consent
  • Diagnosed with post-traumatic stress disorder (PTSD) with a PSSI-5 score >23.
  • Patients must have had an inadequate response to prior treatment i.e. have not responded to at least two adequate trials of relevant medication and at least one trial of relevant psychotherapy.

Exclusion Criteria

  • evidence of severe acute or chronic medical disorders,
  • past or current diagnoses of schizophrenia, bipolar disorder, or current psychotic symptoms
  • current diagnosis of severe personality disorder
  • female patients who are pregnant or lactating
  • drug abuse or dependence in the last 6 months
  • current significant suicidal ideation
  • 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
    Randomized
  • Target Enrollment12 participants
  • Timeline
    Start: 2025-07-31
    End: 2025-12-19
  • Compound
    Ketamine

Locations

Unknown facility — Australia

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