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Trial registered on ANZCTR

Trial ID
Ethics application status
Date submitted
Date registered
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Novel Approach to Treatment Refractory Childhood Obsessive-Compulsive Disorder: D-Cycloserine Augmented Behaviour Therapy
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
Secondary ID 279768 0
Universal Trial Number (UTN)
Trial acronym

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

Study type
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 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

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

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
Both males and females
Can healthy volunteers participate?
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
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
Other design features
Phase 2
Type of endpoint(s)

Anticipated date of first participant enrolment
Actual date of first participant enrolment
Anticipated date last participant enrolled
Actual date last participant enrolled
Target sample size
Actual sample size
Recruitment status
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category 5030 0
Name 5030 0
Australian Rotary Health Research Fund
Address 5030 0
PO Box 3455
Parramatta NSW 2150
Country 5030 0
Primary sponsor
Primary sponsor name
Dr Lara Farrell
Primary sponsor address
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Primary sponsor country
Secondary sponsor category 4547 0
Name 4547 0
Griffith University
Address 4547 0
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country 4547 0
Other collaborator category 619 0
Name 619 0
Professor Harry McConnell
Address 619 0
School of Medicine
Griffith University
Gold Coast Campus
QLD 4222
Country 619 0
Other collaborator category 620 0
Name 620 0
Dr Allison Waters
Address 620 0
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country 620 0
Other collaborator category 621 0
Name 621 0
Dr Mark Boschen
Address 621 0
School of Psychology
Griffith University
Gold Coast Campus
QLD 4222
Country 621 0

Ethics approval
Ethics application status
Ethics committee name 6750 0
Griffith University Human Research Ethics Committee
Ethics committee address 6750 0
Office for Research
Griffith University
Gold Coast Campus
QLD 4222
Ethics committee country 6750 0
Date submitted for ethics approval 6750 0
Approval date 6750 0
Ethics approval number 6750 0

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

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
Phone 12674 0
+61 7 55528224
Fax 12674 0
+ 61 7 55528291
Email 12674 0
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
Phone 3602 0
+61 7 55528224
Fax 3602 0
+61 7 55528291
Email 3602 0