Transcranial Magnetic Stimulation and Oral Ketamine Combination Treatment forPost-Traumatic Stress Disorder (TMS-OK PTSD)

Phase 2

• Conditions: Post-traumatic stress disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12621000342819
• Lead Sponsor: Thompson Institute, University of the Sunshine Coast

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-25
• Study Completion: 2023-11-16
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 28

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:
•Psychosis
•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.
•Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure >150/100)
•Body weight of >130kg
•History of intracranial mass, intracranial haemorrhage/stroke, cerebral trauma/traumatic brain injury or increased intracranial pressure (as assessed by referring general practitioner)
•Liver function test (LFT) results out of normal range, as specified below:
•ALT: >135 U/L
•AST: >123 U/
•GAMMA GT (GGT) male participants: >210 U/L
•GAMMA GT (GGT) – female participants: >135 U/L
•TOTAL BILIRUBIN (BIT): >60 umol/L
•ALBUMIN (A): <25g/L and >150g/L
•ALK PHOS (ALP): >345 U/L
•Previous reaction to ketamine (as reported by referring general practitioner and participant)
•Participants who have undergone TMS treatment previously
•Participants who are pregnant, currently breastfeeding, or who are planning a pregnancy during the trial
•Participants who are simultaneously engaging in another clinical intervention trial while participating in TMS-OK PTSD.
•Participants with a history of substance use disorder (excluding ketamine use disorder), may be eligible to participate in the study if they abstain from use of the substance two weeks prior to participation in the trial and for the remainder of the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PTSD symptomology, as assessed by the PCL-5 between Baseline and Follow-up 1<br>[ The PCL-5 will be administered at the following time points: <br>•Baseline (week 0)<br>•30-60 minutes pre-ketamine treatment <br>•24-hours after ketamine treatment<br>•Follow-up 1 (1 week after final ketamine treatment) (primary endpoint)<br><br>]