Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000352505
Ethics application status
Approved
Date submitted
28/07/2006
Date registered
16/08/2006
Date last updated
16/08/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
The use of D-Cycloserine in combination with exposure therapy to treat social anxiety
Scientific title
A randomised controlled trial to evaluate the effect of D-Cycloserine in combination with exposure therapy in the treatment of social phobia to improve the severity of social phobia symptoms
Secondary ID [1] 291 0
Human Research Ethics Committee (HREC): 04145
Secondary ID [2] 292 0
Clinical Trial Notification (CTN): 2004/443
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social Phobia 1322 0
Condition category
Condition code
Mental Health 1409 1409 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants with social phobia are given exposure therapy over 5 once per week weekly treatment sessions in combination with D-cycloserine (50mg) in capsule form to be swallowed orally. Exposure therapy consists of 3 to 10 minute speech tasks in front of a group (some decrease in anxiety should be observed).
Intervention code [1] 1231 0
Treatment: Drugs
Comparator / control treatment
Participants with social phobia are given exposure therapy over 5 once per week weekly treatment sessions in combination with placebo in capsule form to be swallowed orally.
Control group
Placebo

Outcomes
Primary outcome [1] 1930 0
Severity of Social Phobia symptoms
Timepoint [1] 1930 0
Assessed 4 weeks after the end of 5 weeks of the intervention.
Secondary outcome [1] 3391 0
General functioning includes depression, stress, and self-reported general physical health.
Timepoint [1] 3391 0
Assessed at 4 weeks after the end of 5 weeks of intervention.

Eligibility
Key inclusion criteria
Primary diagnosis of Social Phobia.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Epilepsy, severe kidney disease, Suicide intent, substance dependence, use of contra-inidcated medications, pregnancy.

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 was conducted by numbering drug containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random Order Generation created by computer software. There is no stratification. Drug containers are labelled 1 to 200, contain all four doses of DCS/Placebo. Each number is given (a or b) where DCS could be either a or b for each number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
All particpants, Assessors, therapy and data entry staff are blind to condition
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/05/2006
Actual
Date of last participant enrolment
Anticipated
Actual
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] 1542 0
Government body
Name [1] 1542 0
National Health and Medical Research Council
Country [1] 1542 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Country
Australia
Secondary sponsor category [1] 1355 0
None
Name [1] 1355 0
Nil
Address [1] 1355 0
Country [1] 1355 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2972 0
University of New South Wales
Ethics committee address [1] 2972 0
Ethics committee country [1] 2972 0
Australia
Date submitted for ethics approval [1] 2972 0
Approval date [1] 2972 0
Ethics approval number [1] 2972 0
04145

Summary
Brief summary
This study tests whether d-cycloserine 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 comdination with D-Cycloserine will experience a greater reduction in social anxiety symptoms than individuals who receive placebo in combination with four exposure therapy sessions. Participants receive five weekly group therapy sessions. the first session 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 research staff are blind to condition.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35438 0
Address 35438 0
Country 35438 0
Phone 35438 0
Fax 35438 0
Email 35438 0
Contact person for public queries
Name 10420 0
Adam Guastella
Address 10420 0
School of Psychology
University of New South Wales
Kensington NSW 2052
Country 10420 0
Australia
Phone 10420 0
+61 2 93858071
Fax 10420 0
Email 10420 0
[email protected]
Contact person for scientific queries
Name 1348 0
Adam Guastella
Address 1348 0
School of Psychology
University of New South Wales
Kensington NSW 2052
Country 1348 0
Australia
Phone 1348 0
+61 2 93858071
Fax 1348 0
Email 1348 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.