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
Office for Research
Griffith University
Gold Coast Campus
QLD 4222
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
This research aims to provide preliminary data on a randomised controlled treatment trial for treatment refractory childhood obsessive-compulsive disorder (OCD) – that is, children and adolescents with OCD who continue to suffer disability even after first-line evidence-based treatment. Treatment evaluated in this study will be 5 (+3) sessions augmented behaviour therapy, specifically intensive exposure and response prevention, with D-Cycloserine – an antibiotic drug traditionally used to treat tuberculosis. D-Cycloserine is a glutamatergic partial N-methyl-D-aspartate (NMDA) 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. This drug is yet to be investigated in a sample of children and youth with OCD.
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.