Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000370202
Ethics application status
Approved
Date submitted
25/03/2009
Date registered
27/05/2009
Date last updated
5/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Novel Approach to Treatment Refractory Childhood Obsessive-Compulsive Disorder: D-Cycloserine Augmented Behaviour Therapy
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 refractory pediatric Obsessive-Compulsive Disorder (OCD) to improve the severity of obsessive-compulsive (OC) symptoms
Secondary ID [1] 279768 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric Obsessive-Compulsive Disorder 4518 0
Condition category
Condition code
Mental Health 4802 4802 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
D-Cycloserine and Exposure Therapy versus Pill Placebo and Exposure Therapy. Participants are given 9 weekly 90 minute sessions (once per week) of individual cognitive-behaviour therapy (CBT; involving psychoeducation, relaxation training, cognitive therapy and exposure therapy). Five sessions involve intensive 90 minute exposure therapy (sessions 4 through 8; involving assisting participants to systematically adn gradually face theirs fears whilst resisting any ritualising). One group of participants receives D-Cycloserine (either 25mg or 50 mg depending on weight) before each of the 5 exposure therapy sessions. Each dose is given orally in capsule form 1 hour before each of exposure therapy sessions.
Intervention code [1] 4272 0
Treatment: Other
Comparator / control treatment
Pill placebo (sugar pill) plus CBT (therapy is exactly the same as that provided in the D-Cycloserine condition).
Control group
Placebo

Outcomes
Primary outcome [1] 5661 0
Obsessive-Compulsive symptom severity: Chidlren's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS)
Timepoint [1] 5661 0
Baseline, Post-treatment, 3 month follow-up
Secondary outcome [1] 241548 0
Child and Parent self-report CY-BOCS ratings
Timepoint [1] 241548 0
baseline, sessions 4 through 8, post-treatment and 3 month follow-up

Eligibility
Key inclusion criteria
1. primary diagnosis of OCD with score of at least 19 on CYBOCS at pre- (moderate range);
2. child meets treatment resistant criteria;
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
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria for participation include:
1. organic mental disorder;
2. other medications that are contraindicated with D-Cycloserine (DCS);
3. pregnancy (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 other serious medical condition that would be contraindicated with DCS (ie., 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 webster packages of DCS and placebo for each client. Randomisation concealed with pharmacist/s responsible for dsipensing pills in numbered containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation generetad 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
Completed
Date of first participant enrolment
Anticipated
1/04/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
16
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 5030 0
Charities/Societies/Foundations
Name [1] 5030 0
Australian Rotary Health Research Fund
Country [1] 5030 0
Australia
Primary sponsor type
Individual
Name
Dr Lara Farrell
Address
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country
Australia
Secondary sponsor category [1] 4547 0
University
Name [1] 4547 0
Griffith University
Address [1] 4547 0
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country [1] 4547 0
Australia
Other collaborator category [1] 619 0
Individual
Name [1] 619 0
Professor Harry McConnell
Address [1] 619 0
School of Medicine
Griffith University
Gold Coast Campus
QLD 4222
Country [1] 619 0
Australia
Other collaborator category [2] 620 0
Individual
Name [2] 620 0
Dr Allison Waters
Address [2] 620 0
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country [2] 620 0
Australia
Other collaborator category [3] 621 0
Individual
Name [3] 621 0
Dr Mark Boschen
Address [3] 621 0
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country [3] 621 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6750 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 6750 0
Ethics committee country [1] 6750 0
Date submitted for ethics approval [1] 6750 0
Approval date [1] 6750 0
20/02/2009
Ethics approval number [1] 6750 0
PSY/03/09/HREC

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

Contacts
Principal investigator
Name 29427 0
Address 29427 0
Country 29427 0
Phone 29427 0
Fax 29427 0
Email 29427 0
Contact person for public queries
Name 12674 0
Dr Lara Farrell
Address 12674 0
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country 12674 0
Australia
Phone 12674 0
+61 7 55528224
Fax 12674 0
+ 61 7 55528291
Email 12674 0
[email protected]
Contact person for scientific queries
Name 3602 0
Dr Lara Farrell
Address 3602 0
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country 3602 0
Australia
Phone 3602 0
+61 7 55528224
Fax 3602 0
+61 7 55528291
Email 3602 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
SourceTitleYear of PublicationDOI
Dimensions AIDIFFICULT-TO-TREAT PEDIATRIC OBSESSIVE-COMPULSIVE DISORDER: FEASIBILITY AND PRELIMINARY RESULTS OF A RANDOMIZED PILOT TRIAL OF d-CYCLOSERINE-AUGMENTED BEHAVIOR THERAPY2013https://doi.org/10.1002/da.22132
N.B. These documents automatically identified may not have been verified by the study sponsor.