ACTRN12621000342819终止2 期
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 个研究点目标入组 28 人开始时间: 2021年3月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 28
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
- •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.
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