Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000026729
Ethics application status
Approved
Date submitted
12/12/2012
Date registered
9/01/2013
Date last updated
19/07/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
An investigation of the effects of intranasal oxytocin on socio-emotional brain regions in Huntington’s disease
Scientific title
An investigation of the effects of intranasal oxytocin on socio-emotional brain regions in Huntington’s disease
Secondary ID [1] 281659 0
None
Universal Trial Number (UTN)
U1111-1137-8675
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Huntington's disease 287948 0
Condition category
Condition code
Neurological 288329 288329 0 0
Neurodegenerative diseases
Mental Health 288330 288330 0 0
Other mental health disorders
Human Genetics and Inherited Disorders 288375 288375 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two acute (24 IU) treatment conditions including; a) intranasal placebo, and b) intranasal oxytocin (Syntocinon, Novartis, Switzerland). The two treatment conditions will be separated by a minimum of 1 week (washout period). The nasal sprays will be administered 50 mins prior to the functional magnetic resonance (fMR) protocol. The fMRI protocol will involve showing participants a brief task involving pictures of human faces expressing different emotions.
Intervention code [1] 286199 0
Treatment: Drugs
Comparator / control treatment
Placebo, a saline solution without the active (peptide) ingredient.
Healthy controls will as be used in comparisons to the HD patients.
Control group
Placebo

Outcomes
Primary outcome [1] 288500 0
Functional MRI (fMRI) data will be collected in response to an emotional face expression task. The fMRI data will be compared within the patient (Huntington's disease) group for differences in brain response (e.g., in the amygdala) between placebo and oxytocin conditions.
Timepoint [1] 288500 0
The data will be collected in the 50-80 min post drug administration and will be analysed post all data collection.
Secondary outcome [1] 300333 0
Using the fMRI data, the patients with Huntington's disease will be compared to controls on brain response (e.g., amygdala) under normal (placebo) conditions to see whether hyper- or hypo-activity is present.
Timepoint [1] 300333 0
The data will be collected in the 50-80 min post drug administration and will be analysed post all data collection.

Eligibility
Key inclusion criteria
For Healthy controls: Males; Right-handed; between the ages of 25-55 years; non-smoker and no drug/alcohol abuse; medication free; and no metal objects present in body (or which can't be removed or which is not MRI safe).
For Huntington's disease (HD): As above plus a diagnosis of the disease is required.
Minimum age
25 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically significant medical or neurological condition (other than HD for the patients), significant head injury (or loss of consciousness from longer than 5 mins), presence of ferrous-containing metals within the body, inability to tolerate small enclosed spaces without anxiety.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
20/11/2012
Actual
20/11/2012
Date of last participant enrolment
Anticipated
Actual
20/01/2015
Date of last data collection
Anticipated
Actual
26/02/2015
Sample size
Target
40
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286457 0
University
Name [1] 286457 0
Monash Biomedical Imaging Psych Grant
Country [1] 286457 0
Australia
Funding source category [2] 300185 0
University
Name [2] 300185 0
Monash Biomedical Imaging
Country [2] 300185 0
Australia
Primary sponsor type
University
Name
Monash Biomedical Imaging
Address
Building 220, 770 Wellington rd, Clayton, VIC, 3800
Country
Australia
Secondary sponsor category [1] 285245 0
None
Name [1] 285245 0
Address [1] 285245 0
Country [1] 285245 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288534 0
Monash University Human Research Ethics Committee (MUHREC)
Ethics committee address [1] 288534 0
Ethics committee country [1] 288534 0
Australia
Date submitted for ethics approval [1] 288534 0
Approval date [1] 288534 0
25/09/2012
Ethics approval number [1] 288534 0
CF12/2082 - 2012001135

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

Contacts
Principal investigator
Name 36562 0
Dr Izelle Labuschagne
Address 36562 0
Cognition and Emotion Research Centre
Australian Catholic University
Level 5, Daniel Mannix Building
Young Street, VIC 3065
Country 36562 0
Australia
Phone 36562 0
61 3 9953 3816
Fax 36562 0
Email 36562 0
izelle.labuschagne@acu.edu.au
Contact person for public queries
Name 36563 0
Izelle Labuschagne
Address 36563 0
Cognition and Emotion Research Centre
Australian Catholic University
Level 5, Daniel Mannix Building
Young Street, VIC 3065
Country 36563 0
Australia
Phone 36563 0
61 3 9953 3816
Fax 36563 0
Email 36563 0
izelle.labuschagne@acu.edu.au
Contact person for scientific queries
Name 36564 0
Izelle Labuschagne
Address 36564 0
Cognition and Emotion Research Centre
Australian Catholic University
Level 5, Daniel Mannix Building
Young Street, VIC 3065
Country 36564 0
Australia
Phone 36564 0
61 3 9953 3816
Fax 36564 0
Email 36564 0
izelle.labuschagne@acu.edu.au

No information has been provided regarding IPD availability


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.