An open-label clinical trial of oral ketamine, an NMDA (N-methyl-D-aspartate) receptor antagonist on depressive symptomatology in people aged 16 years and older who are experiencing treatment-resistant depression.

Thompson Institute, University of the Sunshine Coast0 个研究点目标入组 25 人开始时间: 2021年4月16日最近更新: 2024年6月3日

适应症

试验速览

暂无简介。

•Patients who suffer from TRD and determined by cut-off scores of: 17 for the HAM-D
•Persons (male/female/other) aged 16 years and over
•Participants must be able to understand the Participant Information Form (PIF) and provide written informed consent on the Participant Consent Form (PCF)

•Demographic
•Persons under 16 years of age
•Psychiatric conditions
•Mania/hypomania
•Acute suicidality requiring urgent psychiatric intervention
•History of ketamine use disorder
•Recovery from a substance use disorder within prior 6 months
•Physical conditions
•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
•History of epilepsy or unexplained seizures

发起方

Thompson Institute, University of the Sunshine Coast