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Trial registered on ANZCTR


Registration number
ACTRN12612000420842
Ethics application status
Approved
Date submitted
2/03/2012
Date registered
16/04/2012
Date last updated
16/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Novel Treatment of Phobias in Children and Teenagers
Scientific title
A randomised controlled trial to evaluate the effects of D-Cycloserine in combination with exposure therapy, versus pill placebo and exposure therapy, in the treatment of pediatric Specific Phobia to improve symptoms of anxiety, fear and phobic avoidance.
Secondary ID [1] 280046 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric Specific Phobia Disorder 285961 0
Condition category
Condition code
Mental Health 286146 286146 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
D-Cycloserine and exposure therapy versus pill placebo and exposure therapy. Participants receive one individual intensive session (3 hours) of exposure therapy. The session involves assisting participants to systematically and gradually face their fears. Half the participants will receive D-Cycloserine (either 35mg or 70mg depending on child weight) at the commencement of the exposure therapy session. Each dose is given orally in a capsule. The exposure therapy is delivered via trained psychologists.
Intervention code [1] 284369 0
Treatment: Other
Intervention code [2] 284679 0
Treatment: Drugs
Comparator / control treatment
Pill placebo (sugar pill) plus single session of exposure therapy (therapy is exactly the same as that provided in the D-Cycloserine condition)
Control group
Placebo

Outcomes
Primary outcome [1] 286618 0
Anxiety Disorders Interview Schedule (ADIS) - Child/ Parent Versions
Timepoint [1] 286618 0
Pre-Treatment, Post-Treatment, 1 month Follow Up, 3 Month Follow Up and 12 Month Follow up.
Primary outcome [2] 286628 0
Childrens Global Assessment Scale (CGAS) - This a global measure of level of functioning in children and adolscents.
Timepoint [2] 286628 0
Pre-Treatment, Post-Treatment, 1 month Follow Up, 3 Month Follow Up and 12 Month Follow up.
Secondary outcome [1] 296316 0
Fear Survey Schedule for Children Revised
Timepoint [1] 296316 0
Pre-Treatment, Post-Treatment,1 month Follow Up, 3 Month Follow Up and 12 Month Follow up.
Secondary outcome [2] 296317 0
Spence Children's Anxiety Scale
Timepoint [2] 296317 0
Pre-Treatment, Post-Treatment, 1 month Follow Up, 3 Month Follow Up and 12 Month Follow up.

Eligibility
Key inclusion criteria
1. Primary Diagnosis of any Anxiety Disorder
2. DSM-IV-TR Specific Phobia Diagnosis
3. If taking a selective-serotonin reuptake inhibitor (SSRI) medication, dose must be stable for one-month prior to study entry and remain unchanged.
Minimum age
7 Years
Maximum age
17 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participants include:
1. Organic mental disorder
2. Other medications that are contraindicated with D-Cycloserine (DCS)
3. Pregnancy (this will be screened for and if sexually active be required to use birth control)
4. Psychosis
5. Pervasive developmental disorder
6. History of seizure
7. History of other serious medical condition that can be contraindicated with DCS (i.e. cardiovascular, liver, kidney, respiratory etc.)
8. Serious suicidal risk
9. Concurrent psychotherapy
10. Current diagnosis of tuberculosis (TB)
11. Currently taking medication that lowers seizure threshold (ie., clozapine)
12. Impaired intelligence (IQ; likely < 70)

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)
Concealment ensured by using numbered medication bottles of DCS and placebo for each client. Randomisation concealed with pharmacist/s responsible for dispensing pills in numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation generated by a computer-based random numbers table.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284808 0
University
Name [1] 284808 0
Griffith University
Address [1] 284808 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt Queensland 4122
Country [1] 284808 0
Australia
Primary sponsor type
Individual
Name
Dr Allison Waters
Address
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt Queensland 4122
Country
Australia
Secondary sponsor category [1] 283690 0
Individual
Name [1] 283690 0
Dr Lara Farrell
Address [1] 283690 0
School of Applied Psychology
Gold Coast Campus
Griffith University
Parklands Drive
Southport Queensland 4222
Country [1] 283690 0
Australia
Other collaborator category [1] 260580 0
Individual
Name [1] 260580 0
Professor Thomas Ollendick
Address [1] 260580 0
Child Study Center
460 Turner Street
Suite 207
Blacksburg, Virginia, USA 24060
Country [1] 260580 0
United States of America
Other collaborator category [2] 260585 0
Individual
Name [2] 260585 0
Professor Harry McConnell
Address [2] 260585 0
School of Medicine
Gold Coast Campus
Griffith University
Parklands Drive
Southport
Queensland 4222
Country [2] 260585 0
Australia
Other collaborator category [3] 260586 0
Individual
Name [3] 260586 0
Dr Evelin Tiralongo
Address [3] 260586 0
School of Pharmacy
Gold Coast Campus
Griffith University
Parklands Drive
Southport Queensland 4222
Country [3] 260586 0
Australia
Other collaborator category [4] 260587 0
Individual
Name [4] 260587 0
Dr Caroline Donovan
Address [4] 260587 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt Queensland 4122
Country [4] 260587 0
Australia
Other collaborator category [5] 260588 0
Individual
Name [5] 260588 0
Dr Melanie Zimmer-Gembeck
Address [5] 260588 0
School of Applied Psychology
Gold Coast Campus
Griffith University
Parklands Drive
Southport
Queensland 4222
Country [5] 260588 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286796 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 286796 0
Office for Research
Griffith University
Gold Coast Campus
Parklands Drive
Southport
Queensland 4222
Ethics committee country [1] 286796 0
Australia
Date submitted for ethics approval [1] 286796 0
Approval date [1] 286796 0
28/02/2012
Ethics approval number [1] 286796 0
PSY/03/09/HREC

Summary
Brief summary
The aim of this trial is to examine whether D-Cycloserine can augment a single session of graded exposure therapy in children and adolescents with a specific phobia. D-Cycloserine is an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NDMA) agonist, which has recently been shown to facilitate fear extinction in humans and animals and has also demonstrated to improve treatment outcome when combined with exposure therapy in social phobia, acrophobia or fear of heights and OCD in adult samples. The drug has recently been successfully used to augment exposure therapy for children and adolescents with OCD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33848 0
Address 33848 0
Country 33848 0
Phone 33848 0
Fax 33848 0
Email 33848 0
Contact person for public queries
Name 17095 0
Dr Lara Farrell
Address 17095 0
School of Applied Psychology
Griffith Health Institute
Gold Coast Campus
GRIFFITH UNIVERSITY
Parklands Drive
QLD, 4222
Country 17095 0
Australia
Phone 17095 0
+61755528224
Fax 17095 0
+61755528291
Email 17095 0
l.farrell@griffith.edu.au
Contact person for scientific queries
Name 8023 0
Dr Lara Farrell
Address 8023 0
School of Applied Psychology
Griffith Health Institute
Gold Coast Campus
GRIFFITH UNIVERSITY
QLD, 4222
Country 8023 0
Australia
Phone 8023 0
+61755528224
Fax 8023 0
+61755528291
Email 8023 0
l.farrell@griffith.edu.au

No information has been provided regarding IPD availability
Summary results
No Results