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Trial registered on ANZCTR


Registration number
ACTRN12624001442594
Ethics application status
Approved
Date submitted
17/09/2024
Date registered
11/12/2024
Date last updated
11/12/2024
Date data sharing statement initially provided
11/12/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Ketamine Infusion Therapy for Australian Veterans with Treatment Resistant Depression and Post-Traumatic Stress Disorder
Scientific title
Finding an evidence base to support the development of precision medical care for the use of ketamine as a treatment for Australian Veterans with Treatment Resistant Depression and Post-Traumatic Stress Disorder
Secondary ID [1] 312393 0
428-22
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Treatment-Resistant Depression (TRD) 334199 0
Posttraumatic Stress Disorder (PTSD) 334200 0
Condition category
Condition code
Mental Health 330863 330863 0 0
Depression
Mental Health 330864 330864 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ketamine infusion therapy delivered in two phases:

Phase one: Participants will receive six (6) initial intravenous ketamine infusions across two weeks. These initial six infusions are delivered on a Monday-Wednesday-Friday basis across the two weeks. Each infusion will be provided over a 40-minute timespan. In the first infusion, an intravenous ketamine drip will be initiated for a total dose of 0.2 - 0.5 mg/kg. This initial dose is determined by the treating anaesthetist. The dose is then titrated up in following infusion sessions, to a maximum of 1.0 mg/kg. The dosage for these following infusions is determined by the anaesthetists depending on acute clinical response to the previous infusion/s.

Phase two: Participants will receive a further six (6) maintenance intravenous ketamine infusions delivered on a three-to-six weekly basis depending on response. The dosage for these infusions are determined based on which previous dose yielded the best response (i.e., the dose that is determined to have highest benefits combined with lowest side effects). The frequency of these follow-up infusions are determined by the treating team (nurse, psychiatrist, anaesthetist) depending on observed and reported clinical response after intravenous ketamine. For example, if a participant notices a return to baseline symptoms by four weeks following ketamine, the treating team will likely determine that maintenance infusions should be delivered at a three weekly basis.

Infusions are delivered in a hospital setting by an anaesthetist. Hospital nursing staff will prepare infusion logistics, establish venepuncture site, monitor infusion and vital signs during and after infusion (60 minutes). Lead nurses that are involved in ongoing participant care engage in daily monitoring of the treatment: e.g., monitoring adherence to treatment, ketamine response, ketamine dosage, and adverse effects.
Intervention code [1] 328898 0
Treatment: Drugs
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338626 0
Change in depression symptoms.
Timepoint [1] 338626 0
Baseline, mid-treatment 1 (post-induction infusion period), mid-treatment 2 (first follow-up infusion, approximately 1 month following induction infusions), mid-treatment 3 (second follow-up infusion, approximately 2 months following induction infusions), mid-treatment 4 (third follow-up infusion, approximately 3 months following induction infusions), mid-treatment 5 (fourth follow-up infusion, approximately 4 months following induction infusions), mid-treatment 6 (fifth follow-up infusion, approximately 5 months following induction infusions) and post-treatment (sixth follow-up infusion, approximately 6 months following induction infusions).
Primary outcome [2] 338627 0
Change in PTSD symptoms.
Timepoint [2] 338627 0
Baseline, mid-treatment 1 (post-induction infusion period), mid-treatment 2 (first follow-up infusion, approximately 1 month following induction infusions), mid-treatment 3 (second follow-up infusion, approximately 2 months following induction infusions), mid-treatment 4 (third follow-up infusion, approximately 3 months following induction infusions), mid-treatment 5 (fourth follow-up infusion, approximately 4 months following induction infusions), mid-treatment 6 (fifth follow-up infusion, approximately 5 months following induction infusions) and post-treatment (sixth follow-up infusion, approximately 6 months following induction infusions).
Secondary outcome [1] 436694 0
Change in suicidality.
Timepoint [1] 436694 0
Baseline, mid-treatment 1 (post-induction infusion period), mid-treatment 2 (first follow-up infusion, approximately 1 month following induction infusions), mid-treatment 3 (second follow-up infusion, approximately 2 months following induction infusions), mid-treatment 4 (third follow-up infusion, approximately 3 months following induction infusions), mid-treatment 5 (fourth follow-up infusion, approximately 4 months following induction infusions), mid-treatment 6 (fifth follow-up infusion, approximately 5 months following induction infusions) and post-treatment (sixth follow-up infusion, approximately 6 months following induction infusions).
Secondary outcome [2] 439755 0
Change in recovery
Timepoint [2] 439755 0
Baseline, mid-treatment 1 (post-induction infusion period), mid-treatment 2 (first follow-up infusion, approximately 1 month following induction infusions), mid-treatment 3 (second follow-up infusion, approximately 2 months following induction infusions), mid-treatment 4 (third follow-up infusion, approximately 3 months following induction infusions), mid-treatment 5 (fourth follow-up infusion, approximately 4 months following induction infusions), mid-treatment 6 (fifth follow-up infusion, approximately 5 months following induction infusions) and post-treatment (sixth follow-up infusion, approximately 6 months following induction infusions).

Eligibility
Key inclusion criteria
Adults who have been identified as eligible for the ReviveMed treatment program diagnosed with major depression or posttraumatic stress disorder who have not previously responded to pharmacological treatment such as Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitors (SNRI), Tricyclic antidepressants (TCAs) or Monoamine Oxidase Inhibitors (MAOI) antidepressants, or other selected anti psychotic medications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Research-specific exclusion criteria:
1. Inability to provide written informed consent and pass (80%) 10-item comprehension assessment related to study goals, risks, and benefits
2. Not eligible for ketamine treatment as determined by psychiatrist assessing a patient's eligibility for ReviveMed

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/02/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,SA

Funding & Sponsors
Funding source category [1] 316802 0
University
Name [1] 316802 0
University of Queensland
Country [1] 316802 0
Australia
Funding source category [2] 316810 0
Other
Name [2] 316810 0
Zed3 Medical Group
Country [2] 316810 0
Australia
Primary sponsor type
Other
Name
Zed3 Medical Group
Address
Country
Australia
Secondary sponsor category [1] 319025 0
University
Name [1] 319025 0
University of Queensland
Address [1] 319025 0
Country [1] 319025 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315572 0
Department of Defence and Veterans’ Affairs Human Research Ethics Committee
Ethics committee address [1] 315572 0
http://www.defence.gov.au/health/hrec/
Ethics committee country [1] 315572 0
Australia
Date submitted for ethics approval [1] 315572 0
Approval date [1] 315572 0
11/10/2022
Ethics approval number [1] 315572 0

Summary
Brief summary
This study aims to explore neurobiological and blood-based biomarkers that may indicate response to ketamine and determine changes in PTSD symptoms. In doing so, the study also aims to establish the evidence base for precision medical care for the use of ketamine as a treatment for Australian Veterans with TRD and PTSD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135114 0
Dr Alex Lim
Address 135114 0
Zed3 Specialist Centre, Calvary Clinic, Suite 3/40 Mary Potter Cct, Bruce ACT, 2617
Country 135114 0
Australia
Phone 135114 0
+61435721049
Fax 135114 0
Email 135114 0
[email protected]
Contact person for public queries
Name 135115 0
Dr Rachelle Dawson
Address 135115 0
Zed3 Specialist Centre, Calvary Clinic, Suite 3/40 Mary Potter Cct, Bruce ACT, 2617
Country 135115 0
Australia
Phone 135115 0
+610261098830
Fax 135115 0
Email 135115 0
[email protected]
Contact person for scientific queries
Name 135116 0
Dr Rachelle Dawson
Address 135116 0
Zed3 Specialist Centre, Calvary Clinic, Suite 3/40 Mary Potter Cct, Bruce ACT, 2617
Country 135116 0
Australia
Phone 135116 0
+610261098830
Fax 135116 0
Email 135116 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.