Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000197932
Ethics application status
Not yet submitted
Date submitted
16/02/2011
Date registered
21/02/2011
Date last updated
9/01/2019
Date data sharing statement initially provided
9/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of acute ketamine administration on mental representations of the body in healthy participants.
Scientific title
Effects of acute ketamine administration on mental representations of the body in healthy participants.
Secondary ID [1] 253578 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 261139 0
Condition category
Condition code
Mental Health 259292 259292 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
0.16 mg/kg I.V. dose of ketamine administered over an hour.
Intervention code [1] 258009 0
Treatment: Drugs
Comparator / control treatment
Placebo (saline solution) administered once. This is a cross-over trial with a minimum washout between drug and placebo of 14 days, maximum washout of 28 days and a mode (most frequent) of 14 days.
Control group
Placebo

Outcomes
Primary outcome [1] 262104 0
Proprioceptive Drift in the Projected Hand Illusion
Timepoint [1] 262104 0
20 mins after initial dosing
Primary outcome [2] 262105 0
Subjective Experience of the Projected Hand Illusion Questionnaire
Timepoint [2] 262105 0
30 mins after initial dosing
Secondary outcome [1] 273163 0
Plasma ketamine level
Timepoint [1] 273163 0
0 and 90 mins after initial dosing

Eligibility
Key inclusion criteria
Healthy participants
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Pregnancy or currently breastfeeding
2. Neurological disorders or known seizure risk
3. History of loss of consciousness for over 5 mins
4. Current diagnosis or treatment for a mental illness
5. Past or current treatment for substance use disorder
6. Significant risk of psychoses (previous history of psychosis or first-degree relative diagnosed with schizophrenia/schizophrenia-spectrum disorders)
7. Presence or history of a kinetic disorder
8. Presence or history of hypertension
9. Presence or history of hepatic insufficiency
10. Presence of renal insufficiency
11. Presence or history of cardiovascular disorder
12. Significant risk of suicide
13. Known hypersensitivity to ketamine
14. Receiving any systematic prescription medication (excluding oral contraceptive pill)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a within-subject treatment design where the order of treatment (placebo or drug first) is randomised. The person who determines the eligibility for inclusion in the trial is unaware of the treatment being allocated on the day of assessment and medical examination. Allocation of the order of treatment is randomised by the chief investigator (Mathew Martin-Iverson) off-site with a random number table, who does not assess the participants' suitability, does not test the participants or analyse the data. Participants are provided information on the study by an experimenter who is blind to the allocation. Interview and medical examination and decision to include/exclude from the study is conducted by one of two psychiatrists who are unaware of the allocation of treatment schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation of treatment order by random number table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Placebo
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
TRIAL NEVER BEGAN RECRUITMENT DUE TO ISSUES GETTING A SITE TO HOST
Date of first participant enrolment
Anticipated
4/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 258472 0
University
Name [1] 258472 0
University of Western Australia
Country [1] 258472 0
Australia
Primary sponsor type
Individual
Name
Prof. Mathew Martin-Iverson
Address
University of Western Australia
35 Stirling Highway
Crawley, WA
6009
Country
Australia
Secondary sponsor category [1] 257671 0
Individual
Name [1] 257671 0
A/Prof Flavie Waters
Address [1] 257671 0
University of Western Australia
35 Stirling Highway
Crawley, WA
6009
Country [1] 257671 0
Australia
Other collaborator category [1] 251812 0
Individual
Name [1] 251812 0
Prof. Thomas Ledowski
Address [1] 251812 0
University of Western Australia
35 Stirling Highway
Crawley, WA
6009
Country [1] 251812 0
Australia
Other collaborator category [2] 251813 0
Individual
Name [2] 251813 0
Kyran Graham
Address [2] 251813 0
CCRN
Gascoyne House
John XXIII Avenue
Mt Claremont Western Australia 6010
Country [2] 251813 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260450 0
North Metropolitan Area Mental Health Services
Human Research Ethics Committee
Ethics committee address [1] 260450 0
Ethics committee country [1] 260450 0
Australia
Date submitted for ethics approval [1] 260450 0
16/03/2011
Approval date [1] 260450 0
Ethics approval number [1] 260450 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32194 0
Prof Mathew Martin-Iverson
Address 32194 0
Pharmacology M510, UWA,
35 Stirling Highway,
Crawley WA 6009
Australia
Country 32194 0
Australia
Phone 32194 0
+61 (8) 6457-2982
Fax 32194 0
Email 32194 0
[email protected]
Contact person for public queries
Name 15441 0
Prof. Mathew Martin-Iverson
Address 15441 0
University of Western Australia
35 Stirling Highway
Crawley, WA
6009
Country 15441 0
Australia
Phone 15441 0
+61 8 9347 6430
Fax 15441 0
+61 8 9384-4128
Email 15441 0
[email protected]
Contact person for scientific queries
Name 6369 0
Prof. Mathew Martin-Iverson
Address 6369 0
University of Western Australia
35 Stirling Highway
Crawley, WA
6009
Country 6369 0
Australia
Phone 6369 0
+61 8 9347 6443
Fax 6369 0
+61 8 9384-4128
Email 6369 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
No data collected to share


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.