Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000141448
Ethics application status
Approved
Date submitted
20/02/2007
Date registered
23/02/2007
Date last updated
26/08/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Oxytocin on Amygdala Response to Threat in Generalised Social Anxiety Disorder: A Functional Magnetic Resonance Imaging (fMRI) Study
Scientific title
A placebo-controlled, randomised phase III trial investigating the effects of oxytocin, a neuropeptide, on the neural circuit (i.e. amgydala) involved in threat processing in Generalised Social Anxiety Disorder using functional magnetic resonance imaging (fMRI).
Secondary ID [1] 285233 0
Nil know
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Generalised Social Anxiety Disorder 1635 0
Condition category
Condition code
Mental Health 1743 1743 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two intranasal treatment conditions: (1) Oxytocin Nasal Spray (24IU or 40.3mg) and (2) Placebo. Administration at 50 mins prior to fMRI scanning procedure. There is a minimum washout period of 1 week in between 2 fMRI sessions. The two groups, involving patients with Generalised Social Anxiety Disorder (GSAD) and healthy controls, will both receive the same interventions (placebo and oxytocin) during the time span of the study, but in different sequences during the study. All participants act as their own control due to placebo condition. However it is also of interest to compare the group of Generalised Social Anxiety Disorder patient with a control/comparison group of healthy controls. The allocation of the conditions is blinded and randomised.
Intervention code [1] 1614 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Placebo

Outcomes
Primary outcome [1] 2430 0
fMRI data will be collected to investigate whether oxytocin affects the amygdala response to threatening (vs. non-threatening) facial expression processing in patients with Generalised Social Anxiety Disorder (GSAD) relative to healthy controls.
Timepoint [1] 2430 0
50 minutes post drug administration
Secondary outcome [1] 4198 0
The fMRI data collected 50 minutes post drug adminstration will also be used to investigate the effects of oxytocin (vs. placebo) on functional connectivity (ie. Amygdala-Brainstem, Amygdala-Insula) in patients with Generalised Anxiety Disorder (GSAD) compared to healthy controls.
Timepoint [1] 4198 0
Functional connectivity will be investigated during the analysis using correlation analysis, which is done post data collection during data analysis. This data used is collected at 50 minutes post drug administration.

Eligibility
Key inclusion criteria
Right-handed, non-smokers, psychotropic medication free for a minimum of 2 weeks (8 weeks for fluoxetine, 4 weeks for monoamine oxidase inhibitors), not taking hormonal contraceptives, and do not have comorbid alcohol or substance abuse or dependence. Additional inclusion for GSAD participants - Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) GSAD as primary diagnosis.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Clinically significant medical or neurologic condition (not applicable to GSAD patients, see inclusion criteria), current/recent depressive episode, life history of bipolar, schizophrenia, obsessive compulsive disorder, post-traumatic stress disorder or presence of organic mental syndrome, mental retardation, or pervasive developmental disorder, pregnancy or lactation, 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)
Allocation concealment will be conducted by labeling the spray bottles with numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised randomisation procedure
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
This is a double-blind design study where both the assessor and the participant will be blind to which drug condition is applied at the time of testing.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/04/2007
Actual
12/03/2008
Date of last participant enrolment
Anticipated
Actual
17/11/2009
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1892 0
University
Name [1] 1892 0
School of Psychology, Psychiatry and Psychological Medicine, Monash University
Country [1] 1892 0
Australia
Primary sponsor type
University
Name
School of Psychology, Psychiatry and Psychological Medicine, Monash University
Address
School of Psychology, Psychiatry and Psychological Medicine, Monash University, Clayton, 3800
Country
Australia
Secondary sponsor category [1] 1711 0
None
Name [1] 1711 0
None
Address [1] 1711 0
Country [1] 1711 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3517 0
Monash Medical Centre-Southern Health Human Research Ethics Committee
Ethics committee address [1] 3517 0
Ethics committee country [1] 3517 0
Australia
Date submitted for ethics approval [1] 3517 0
19/03/2007
Approval date [1] 3517 0
21/05/2007
Ethics approval number [1] 3517 0
Ethics committee name [2] 3518 0
Monash University-Standing Committee on Ethics in Research involving Humans
Ethics committee address [2] 3518 0
Ethics committee country [2] 3518 0
Australia
Date submitted for ethics approval [2] 3518 0
Approval date [2] 3518 0
31/05/2007
Ethics approval number [2] 3518 0

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

Contacts
Principal investigator
Name 27548 0
Prof Pradeep Nathan
Address 27548 0
Department of Psychiatry
Cambridge University
Forvie Site, Robinson Way
Cambridge CB2 0SZ, UK
Country 27548 0
United Kingdom
Phone 27548 0
+44 1223296081
Fax 27548 0
Email 27548 0
[email protected]
Contact person for public queries
Name 10803 0
Izelle Labuschagne
Address 10803 0
Behavioural Neuroscience Laboratory
School of Psychology
Psychiatry and Psychological Medicine
Monash University
Clayton VIC 3800
Country 10803 0
Australia
Phone 10803 0
+61 3 9594 5543
Fax 10803 0
Email 10803 0
[email protected]
Contact person for scientific queries
Name 1731 0
Pradeep J. Nathan
Address 1731 0
Department of Psychiatry
Cambridge University
Forvie Site, Robinson Way
Cambridge CB2 0SZ, UK
Country 1731 0
Australia
Phone 1731 0
+61 3 99054319
Fax 1731 0
Email 1731 0
[email protected]

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.