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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]

NIL

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Pediatric Specific Phobia Disorder

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

Anxiety Disorders Interview Schedule (ADIS) - Child/ Parent Versions

Timepoint [1]

Pre-Treatment, Post-Treatment, 1 month Follow Up, 3 Month Follow Up and 12 Month Follow up.

Primary outcome [2]

Childrens Global Assessment Scale (CGAS) - This a global measure of level of functioning in children and adolscents.

Timepoint [2]

Pre-Treatment, Post-Treatment, 1 month Follow Up, 3 Month Follow Up and 12 Month Follow up.

Secondary outcome [1]

Fear Survey Schedule for Children Revised

Timepoint [1]

Pre-Treatment, Post-Treatment,1 month Follow Up, 3 Month Follow Up and 12 Month Follow up.

Secondary outcome [2]

Spence Children's Anxiety Scale

Timepoint [2]

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

Sex

Both males and females

Can healthy volunteers participate?

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

5/03/2012

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]

University

Name [1]

Griffith University

Address [1]

School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt Queensland 4122

Country [1]

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]

Individual

Name [1]

Dr Lara Farrell

Address [1]

School of Applied Psychology
Gold Coast Campus
Griffith University
Parklands Drive
Southport Queensland 4222

Country [1]

Australia

Other collaborator category [1]

Individual

Name [1]

Professor Thomas Ollendick

Address [1]

Child Study Center
460 Turner Street
Suite 207
Blacksburg, Virginia, USA 24060

Country [1]

United States of America

Other collaborator category [2]

Individual

Name [2]

Professor Harry McConnell

Address [2]

School of Medicine
Gold Coast Campus
Griffith University
Parklands Drive
Southport
Queensland 4222

Country [2]

Australia

Other collaborator category [3]

Individual

Name [3]

Dr Evelin Tiralongo

Address [3]

School of Pharmacy
Gold Coast Campus
Griffith University
Parklands Drive
Southport Queensland 4222

Country [3]

Australia

Other collaborator category [4]

Individual

Name [4]

Dr Caroline Donovan

Address [4]

School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt Queensland 4122

Country [4]

Australia

Other collaborator category [5]

Individual

Name [5]

Dr Melanie Zimmer-Gembeck

Address [5]

School of Applied Psychology
Gold Coast Campus
Griffith University
Parklands Drive
Southport
Queensland 4222

Country [5]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Griffith University Human Research Ethics Committee

Ethics committee address [1]

Office for Research
Griffith University
Gold Coast Campus
Parklands Drive
Southport 
Queensland 4222

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/02/2012

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Lara Farrell

Address

School of Applied Psychology
Griffith Health Institute
Gold Coast Campus
GRIFFITH UNIVERSITY
Parklands Drive
QLD, 4222

Country

Australia

Phone

+61755528224

Fax

+61755528291

[email protected]

Contact person for scientific queries

Name

Dr Lara Farrell

Address

School of Applied Psychology
Griffith Health Institute
Gold Coast Campus
GRIFFITH UNIVERSITY
QLD, 4222

Country

Australia

Phone

+61755528224

Fax

+61755528291

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Farrell, L. J., Waters, A. M., Oar, E. L., Tiralon... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	D-cycloserine-augmented one-session treatment of specific phobias in children and adolescents.	2018	https://dx.doi.org/10.1002/brb3.984

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically