Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000140651
Ethics application status
Approved
Date submitted
20/12/2013
Date registered
5/02/2014
Date last updated
14/03/2022
Date data sharing statement initially provided
14/03/2022
Date results information initially provided
14/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Intensive treatment of Pediatric Obsessive Compulsive Disorder (OCD): Improving access and outcomes
Scientific title
A randomised controlled trial to evaluate the effects of D-Cycloserine in combination with intensive exposure therapy, versus pill placebo in combination with intensive exposure therapy in the treatment of pediatric Obsessive Compulsive Disorder to improve the severity of obsessive compulsive symptoms.
Secondary ID [1] 283632 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric Obsessive Compulsive Disorder 290572 0
Condition category
Condition code
Mental Health 290966 290966 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
D-cycloserine (DCS) augmented intensive exposure therapy versus pill placebo and intensive exposure therapy. Participants receive three individual intensive exposure therapy sessions. Each intensive session will be 3 hours in duration and spaced one week apart. The sessions involve assisting participants to systematically and gradually face their fears whilst resisting any ritualising. There will be three conditions examining the timing of dosing DCS. One third of participants will be given DCS immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions and a placebo pill immediately following the session.One third of participants will be given a placebo pill immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions and DCS immediately following the session and one third of participants will be given a placebo pill immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions and a placebo pill immediately following the session.Participants will remain in the same dosing conditions across all treatment sessions.The DCS dosage will be 35mg or 70mg depending on the child's weight. Children weighing 25kg to 45kg will receive 35mg DCS which equals a range of 1.4mg/kg to 0.78 mg/kg and children 46kg to 90kg, will be given a dose of 70mg, which equates to a range of 1.5mg/kg to 0.78mg/kg. Each dose is given orally in a capsule. The exposure therapy is delivered via trained psychologists.
Intervention code [1] 288326 0
Treatment: Other
Intervention code [2] 288327 0
Treatment: Drugs
Comparator / control treatment
Pill placebo (sugar pill) and intensive exposure therapy
Control group
Placebo

Outcomes
Primary outcome [1] 290945 0
Obsessive Compulsive Symptom Severity: Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS), Diagnostic profile
Timepoint [1] 290945 0
Pre treatment, Post treatment, 1 Month and 6 Month Follow Up
Secondary outcome [1] 305641 0
Child and Parent self report CY-BOCS ratings
Timepoint [1] 305641 0
Pre treatment, Intensive Treatment Sessions, Post Treatment, 1 Month and 6 Month Follow ups

Eligibility
Key inclusion criteria
Inclusion criteria will include -
(a) primary diagnosis of OCD with score of at least 16 on CYBOCS at pre- (moderate range)
(b) aged 7-17 years
(c) at least one parent willing to attend
(d) suspected IQ within at least average range
(e) willingness to cease any other concurrent psychotherapy if taking psychotropic medication, dose must be stable for at least 12 weeks prior to study entry
(g) if taking psychotropic medication, current dose must be stable for at least 6 weeks prior to entering trial
(h) willingness to keep mediation stable for the duration of the project, unless under medical advice to change dose or medication
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria include -
(a) diagnosis of Autistic Spectrum Disorder (or pervasive developmental disorder)
(b) suicidal ideation
(c) intellectual impairment or diagnosed learning disorder
(d) psychosis
(e) organic mental disorder
(f) other medications that are contraindicated with DCS
(g) pregnancy (will be screened for and if sexually active be required to use birth control)
(h) history of seizure
(i) history other serious medical condition that would be contraindicated with DCS (ie., cardiovascular, liver , kidney, respiratory etc)
(j) concurrent psychotherapy
(k) current diagnosis of TB
(l) currently taking medication that lowers seizure threshold (ie., clozapine);

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 dispensing pills in numbered webster packages.
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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The present study aims to recruit for a final sample size of n=20 per cell with sample size based on power calculations (Gpower).

Power analysis calculations for an effect size for F of (n2) 0.20 (based on our time x group interaction effect sizes for our refractory OCD DCS trial, Farrell et al., 2013), with a level of 0.05, indicated n of 19 per cell for 90% power. We will recruit additional children to account for 5% attrition in line with previous trials (0-5% attrition).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
28/01/2014
Actual
28/01/2014
Date of last participant enrolment
Anticipated
Actual
20/07/2015
Date of last data collection
Anticipated
Actual
24/11/2015
Sample size
Target
60
Accrual to date
Final
52
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 288315 0
Charities/Societies/Foundations
Name [1] 288315 0
Foundation for Children Grant
Country [1] 288315 0
Australia
Primary sponsor type
Individual
Name
Dr Lara Farrell
Address
School of Applied Psychology
Gold Coast Campus
Griffith University
Parklands Drive
Southport Queensland 4222
Country
Australia
Secondary sponsor category [1] 287031 0
Individual
Name [1] 287031 0
Dr Allison Waters
Address [1] 287031 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mt Gravatt Queensland 4122
Country [1] 287031 0
Australia
Secondary sponsor category [2] 287032 0
Individual
Name [2] 287032 0
Professor Harry McConnell
Address [2] 287032 0
School of Medicine
Gold Coast Campus
Griffith University
Parklands Drive
Southport Queensland 4222
Country [2] 287032 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290206 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 290206 0
Office for Research
Griffith University
Gold Coast Campus
Parklands Drive
Southport
Queensland 4222
Ethics committee country [1] 290206 0
Australia
Date submitted for ethics approval [1] 290206 0
Approval date [1] 290206 0
19/08/2013
Ethics approval number [1] 290206 0
PSY/A4/13/HREC

Summary
Brief summary
The aim of the study is to examine whether D-Cycloserine can augment graded exposure therapy for children and adolescents with Obsessive Compulsive Disorder. D-Cycloserine is 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. The drug has recently been used to augment exposure therapy for children and adolescents with OCD. A secondary aim of the study is to systematically examine the timing of D-Cycloserine augmentation in a pediatric sample by comparing D-Cycloserine given immediately before or immediately after exposure therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44474 0
Dr Lara Farrell
Address 44474 0
School of Applied Psychology
Griffith Health Institute
Gold Coast Campus
Griffith University
Parklands Drive
QLD 4222
Country 44474 0
Australia
Phone 44474 0
+61756788224
Fax 44474 0
+61756788291
Email 44474 0
[email protected]
Contact person for public queries
Name 44475 0
Dr Lara Farrell
Address 44475 0
School of Applied Psychology
Griffith Health Institute
Gold Coast Campus
Griffith University
Parklands Drive
QLD 4222
Country 44475 0
Australia
Phone 44475 0
+61756788224
Fax 44475 0
+61756788291
Email 44475 0
[email protected]
Contact person for scientific queries
Name 44476 0
Dr Lara Farrell
Address 44476 0
Griffith Health Institute
Gold Coast Campus
Griffith University
Parklands Drive
QLD 4222
Country 44476 0
Australia
Phone 44476 0
+61756788224
Fax 44476 0
+61756788291
Email 44476 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.