Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000256471
Ethics application status
Approved
Date submitted
7/03/2007
Date registered
14/05/2007
Date last updated
14/05/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of Oxytocin in combination with exposure therapy to treat social anxiety symptoms.
Scientific title
A randomised controlled trial to evaluate the effect of Oxytocin (OT; 24 IU) in combination with exposure therapy for the treatment of social phobia to improve the severity of social phobia symptoms.
Secondary ID [1] 364 0
Therapeutic Goods Association Clinical Trial Notification (TGA CTN): YGA CTN - 2006/314
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Phobia 1795 0
Condition category
Condition code
Mental Health 1881 1881 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with social phobia are given group exposure based therapy over 5 weekly treatment sessions in combination with a Nasal Spray dose of Oxytocin (OT; 24 IU). Exposure therapy consists of 3 to 10 minute speech tasks in front of a group where a decrease in anxiety within this situation is observed.
Intervention code [1] 1594 0
Treatment: Drugs
Comparator / control treatment
Placebo matched Nasal spray taken only before therapy sessions once a week for four weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 2672 0
Severity of Social Phobia Symptoms
Timepoint [1] 2672 0
Assessed one month post-treatment
Secondary outcome [1] 4531 0
General functioning
Timepoint [1] 4531 0
Assessed at one-month follow-up.

Eligibility
Key inclusion criteria
University students over the age of 18.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under 18, pregnancy, epilepsy, substance abuse/ dependence, psychotic symptoms, suicidal thoughts. Participants are also instructed not to drink alcohol, caffeine or take any illegal drugs on the day of Oxytocin (OT) administration, and to abstain from fluids and food, except water, two hours before OT administration.

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)
Drug Allocation Concealmet is conducted by numbering all containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation using computer software. There is no stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All subjects, assessors, therapists, and data entry staff are blind to drug condition
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final

Funding & Sponsors
Funding source category [1] 2028 0
University
Name [1] 2028 0
University of New South Wales
Country [1] 2028 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3760 0
University of New South Wales
Ethics committee address [1] 3760 0
Ethics committee country [1] 3760 0
Australia
Date submitted for ethics approval [1] 3760 0
Approval date [1] 3760 0
Ethics approval number [1] 3760 0
HREC06266

Summary
Brief summary
This study tests whether Oxytocin improves the effectiveness of exposure therapy for decreasing social anxiety symptoms. We predict that individuals from the community diagnosed with social phobia who receive four exposure therapy sessions in combination with Oxytocin will experience a greater reduction in social anxiety symptoms in comparison to individuals who received the placebo in combination with four exposure therapy sessions. Participants receive, in total, five weekly group therapy sessions, the first is educational and the next four consist of public speaking exposure therapy. One month post intervention participants are assessed for social anxiety symptoms as well as other general health indicators. All subjects, therapists, assessors, and data entry staff are blind to condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27528 0
Address 27528 0
Country 27528 0
Phone 27528 0
Fax 27528 0
Email 27528 0
Contact person for public queries
Name 10783 0
Dr. Adam Guastella
Address 10783 0
School of Psychology
University of New South Wales
Kensington, 2052
Country 10783 0
Australia
Phone 10783 0
02 9385 8071
Fax 10783 0
02 9385 3641
Email 10783 0
[email protected]
Contact person for scientific queries
Name 1711 0
Dr. Adam Guastella
Address 1711 0
School of Psychology
University of New South Wales
Kensington NSW 2052
Country 1711 0
Australia
Phone 1711 0
02 9385 8071
Fax 1711 0
02 9385 3641
Email 1711 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.