ACTRN12618001937202已完成1 期
A longitudinal open-label, dose-ranging clinical trial to evaluate the effectiveness of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist, in patients who are experiencing chronic suicidal ideation.
Sunshine Coast Mind and Neuroscience - Thompson Institute, University of the Sunshine Coast0 个研究点目标入组 8 人开始时间: 2018年11月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
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
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participant Inclusion Criteria for OKTOS-E (Phase 1):
- •Participants must have previously completed the Oral Ketamine Trial on Suicidality (OKTOS) (Bellberry Limited Application ID 2017-12-982) including the four-week follow-up phase.
- •Participant continues to receive a score equal to or above 6 for the Scale for Suicidal Ideation (SSI) at the completion of OKTOS OR participant receives a score >6 for the Scale for Suicidal Ideation (SSI) at any time within 12 weeks of completing OKTOS.
- •Persons (male/female/other) aged over 18 years.
- •Participant to receive physical examination from Principal Investigator within 14 days prior to commencement of ketamine treatment to eliminate possibility of conditions outlined in exclusion criteria.
- •Participants must be able to understand the PIF and provide written informed consent on the Participant Consent Form (PCF).
- •Total avoidance of pregnancy for the duration of the study through abstinence or adequate and highly effective contraception (i.e. methods resulting in a low failure rate [less than 1% per year]) and/or the inability to become pregnant through age or surgical sterilization.
- •Male participants must avoid fathering a child during the study and for 3 months following the final ketamine treatment.
- •Participant Inclusion Criteria for OKTOS-M (Phase 2):
- •Participants must have previously completed the Oral Ketamine Trial on Suicidality (OKTOS) (Bellberry Limited Application ID 2017-12-982) and the Extended Oral Ketamine Trial on Suicidality (OKTOS-E).
- •Persons (male/female/other) aged over 18 years.
- •Participant to receive physical examination from Principal Investigator within 14 days prior to commencement of ketamine treatment to eliminate possibility of conditions outlined in exclusion criteria.
- •Participants must be able to understand the PIF and provide written informed consent on the Participant Consent Form (PCF).
- •Total avoidance of pregnancy for the duration of the study through abstinence or adequate and highly effective contraception (i.e. methods resulting in a low failure rate [less than 1% per year]) and/or the inability to become pregnant through age or surgical sterilization.
- •Male participants must avoid fathering a child during the study and for 3 months following the final ketamine treatment.
排除标准
- •Persons under 18 years of age
- •Mania/hypomania
- •Acute suicidality requiring urgent psychiatric intervention
- •Uncontrolled/severe symptomatic cardiovascular disease states including: recent myocardial infarction (within prior 6 months); history of stroke; and hypertension (resting blood pressure >150/100)
- •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)
- •Pregnant women
- •Breastfeeding women
- •Experiencing any adverse event/s (AEs) during OKTOS or OKTOS-E
- •Experiencing any unexpected adverse reaction/s (UARs) during OKTOS or OKTOS-E
- •Experiencing any serious adverse event/s (SAEs) during OKTOS or OKTOS-E
- •Experiencing any known but intolerable side effects during OKTOS or OKTOS-E
研究者
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