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Clinical Trials/ACTRN12621000342819
ACTRN12621000342819
Terminated
Phase 2

The Effect of Transcranial Magnetic Stimulation and Oral Ketamine Combination Treatment on severity of symptoms in Post-Traumatic Stress Disorder (TMS-OK PTSD)

Thompson Institute, University of the Sunshine Coast0 sites28 target enrollmentMarch 25, 2021

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Post-traumatic stress disorder
Sponsor
Thompson Institute, University of the Sunshine Coast
Enrollment
28
Status
Terminated
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 25, 2021
End Date
November 16, 2023
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Thompson Institute, University of the Sunshine Coast

Eligibility Criteria

Inclusion Criteria

  • Current PTSD diagnosis
  • Persons (male/female/other) aged over 18 years
  • Participants must be able to understand and provide consent on the Participant Information and Consent Form (PICF).
  • Participants must be able to tolerate the ketamine treatment, TMS treatment/sham TMS treatment, rating scales, blood testing and urinalysis in order to remain in the study and this will be monitored on an ongoing basis, as per the methodology.

Exclusion Criteria

  • Psychiatric conditions:
  • Mania/hypomania
  • Acute suicidality requiring urgent psychiatric intervention
  • History of ketamine use disorder
  • History of epilepsy/seizures
  • Physical conditions:
  • Participants who have active or inactive implants (including device leads), including deep brain stimulators, cochlear implants, and vagus nerve stimulators.
  • The presence of ferrous metal pins or plates in or near the head (within 30 cm of the coil). Including: implanted electrodes/stimulators, aneurysm clips or coils, stents, or bullet fragments.
  • Participants who have history of epilepsy or unexplained seizure history.
  • Participants who have previously undergone TMS treatment.

Outcomes

Primary Outcomes

Not specified

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