Trial from ANZCTR


Trial ID ACTRN12609000370202
Trial Status: Registered
Date Submitted: 25/03/2009
Date Registered: 27/05/2009
Retrospectively registered

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Public title A Novel Approach to Treatment Refractory Childhood Obsessive-Compulsive Disorder: D-Cycloserine Augmented Behaviour Therapy
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format 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
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Secondary ID [1] 279768 0
NIL
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UTN
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Trial acronym
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Health condition(s) or problem(s) studied:
Pediatric Obsessive-Compulsive Disorder 4518 0
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Mental Health Other mental health disorders
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4802 4802 0 0

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Descriptions 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.
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Intervention Code:
Treatment: Other 4272 0
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Comparator / control treatment Pill placebo (sugar pill) plus CBT (therapy is exactly the same as that provided in the D-Cycloserine condition).
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Control group Placebo
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Primary Outcome: Obsessive-Compulsive symptom severity: Chidlren's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) 5661 0
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Timepoint: Baseline, Post-treatment, 3 month follow-up 5661 0
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Secondary Outcome: Child and Parent self-report CY-BOCS ratings 241548 0
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Timepoint: baseline, sessions 4 through 8, post-treatment and 3 month follow-up 241548 0
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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.
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Minimum age 8 Years
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Maximum age 17 Years
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Gender Both males and females
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Healthy volunteers? No
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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).
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Study type Interventional
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Purpose of the study Treatment
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Allocation to intervention Randomised controlled trial
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Describe the 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.
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Describe the 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.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Phase 2
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Anticipated date of first participant enrolment 1/04/2009
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled
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Actual date last participant recruited/enrolled
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Target sample size 16
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Recruitment status Completed
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

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Funding Source: Charities/Societies/Foundations 5030 0
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Name: Australian Rotary Health Research Fund 5030 0
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Address: PO Box 3455
Parramatta NSW 2150
5030 0
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Country: Australia 5030 0
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Primary Sponsor Individual
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Name: Dr Lara Farrell
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Address: School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
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Country: Australia
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Secondary Sponsor: University 4547 0
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Name: Griffith University 4547 0
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Address: School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
4547 0
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Country: Australia 4547 0
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Other Collaborator: Individual 619 0
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Name: Professor Harry McConnell 619 0
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Address: School of Medicine
Griffith University
Gold Coast Campus
QLD 4222
619 0
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Country: Australia 619 0
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Other Collaborator: Individual 620 0
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Name: Dr Allison Waters 620 0
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Address: School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
620 0
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Country: Australia 620 0
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Other Collaborator: Individual 621 0
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Name: Dr Mark Boschen 621 0
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Address: School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
621 0
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Country: Australia 621 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Griffith University Human Research Ethics Committee 6750 0
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Address: Office for Research
Griffith University
Gold Coast Campus
QLD 4222
6750 0
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Country: 6750 0
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Approval Date: 20/02/2009 6750 0
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Submitted Date: 6750 0
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HREC: PSY/03/09/HREC 6750 0
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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.
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Trial website
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Public Notes
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Principal Investigator
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Contact person for public queries
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Name: Dr Lara Farrell
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Address: School of Psychology Griffith University Gold Coast Campus QLD 4222
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Country: Australia
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Tel: +61 7 55528224
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Fax: + 61 7 55528291
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Email: l.farrell@griffith.edu.au
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Contact person for scientific queries
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Name: Dr Lara Farrell
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Address: School of Psychology Griffith University Gold Coast Campus QLD 4222
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Country: Australia
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Tel: +61 7 55528224
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Email: l.farrell@griffith.edu.au
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