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Trial registered on ANZCTR


Registration number
ACTRN12616000473460
Ethics application status
Approved
Date submitted
24/09/2015
Date registered
11/04/2016
Date last updated
11/04/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of D-Cycloserine in combination with intensive exposure therapy in the treatment of obsessive compulsive disorder (OCD) in children
Scientific title
Efficacy of D-Cycloserine in combination with intensive exposure therapy in the treatment of obsessive compulsive disorder (OCD) in children
Secondary ID [1] 286974 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pediatric Obsessive Compulsive Disorder 295433 0
Condition category
Condition code
Mental Health 295686 295686 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 four individual intensive exposure therapy sessions. All intensive sessions will be 3 hours in duration. The first three intensive sessions will be spaced one week apart. The final booster intensive session will be one month after the third intensive session. The sessions involve assisting participants to systematically and gradually face their fears whilst resisting any ritualising. There will be two conditions. Half of participants will be given DCS immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions and half will be given a placebo pill immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions. Participants will remain in the same dosing conditions across all treatment sessions. Particiapants will therefore have four doses of DCS or Placebo during the trial. 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 and supervised administration occurs by the therapy psychologist. The exposure therapy is delivered via trained psychologists.
Intervention code [1] 292178 0
Treatment: Other
Intervention code [2] 292179 0
Treatment: Drugs
Comparator / control treatment
Pill placebo (sugar pill) and intensive exposure therapy
Control group
Placebo

Outcomes
Primary outcome [1] 295392 0
Obsessive Compulsive Diagnostic Severity (ADIS-P, CSR)
Timepoint [1] 295392 0
Pre-treatment, Post intensive, Post Booster, 3-month follow-up, 6 month follow-up
Primary outcome [2] 297948 0
CYBOCS Total OCD severity
Timepoint [2] 297948 0
Pe-treatment, Post intensive, Post Booster, 3-month follow-up, 6 month follow-up
Primary outcome [3] 297949 0
NIMH CGI Severity - Clinical Global Severity / Improvements
Timepoint [3] 297949 0
Pre-treatment, Post intensive, Post Booster, 3-month follow-up, 6 month follow-up
Secondary outcome [1] 315502 0
Target symptoms - top three symptoms child and parent reported and ratings of severity using 9-point Likert scale response (How severe has this symptom been in the past week)
Timepoint [1] 315502 0
Pre-treatment, Post Intensive, Post Booster, 3-month follow-up, 6 month follow-up
Secondary outcome [2] 322680 0
functional impairment - Child OCD Impact Scale (child and parent version)
Timepoint [2] 322680 0
Pre, Post-treatment, Post-Booster, 3 month follow-up
Secondary outcome [3] 322731 0
Anxiety - Multidimensional Anxiety Scale for Children (child report)
Timepoint [3] 322731 0
Pre-treatment, Post intensive, Post Booster, 3-month follow-up
Secondary outcome [4] 322732 0
Depression - Children's Depression Inventory
Timepoint [4] 322732 0
Pre-treatment, Post intensive, Post Booster, 3-month follow-u

Eligibility
Key inclusion criteria
Inclusion criteria -
(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 and ability to understand cognitive components of treatment -

IQ will not be formally assessed in this project. Rather, this will be based on parent report of children’s general intellectual functioning during intake screening, and will involve asking the parent if they consider their child’s intellectual functioning to be at least in the low average range for children his/her age and they could understand general cognitive components of treatment.

(e) willingness to cease any other concurrent psychotherapy related to OCD treatment
(f) If taking psychotropic medication the following stabilization periods need to be completed prior to study entry
*If SSRI stable for 12 weeks prior to entering the study
* 6 weeks stable for ADHD or atypical antipsychotics
* Dose increases need to be stable for 8 weeks
*Dose decrease needs to be stable for 8 weeks
(g) 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 a Level 2 or 3 Autistic Spectrum Disorder based on newly revised DSM-V criteria
(b) Current suicidal ideation and risk or/evidence of intent.
Children with OCD are often extremely distressed by their condition, and whilst they may not be depressed and at risk of suicide based on our risk assessment, they may well express some thoughts of suicide. We routinely screen for risk, as does our independent Psychiatrist who screens all children, and as is current professional standards, deem them NOT at immediate risk if there is no intent - that is, if they have not thought about a plan to hurt themselves, and report no plan to actually act on their thoughts.
(c) intellectual impairment or previously 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) epilepsy or history of seizure
(i) history other serious medical condition that would be contraindicated with DCS (ie., cardiovascular, liver , kidney, respiratory etc),
(j) concurrent psychotherapy related to OCD treatment
(k) current diagnosis of Tuberculosis
(l) currently taking clozapine, or medication that lowers seizure threshold
(m) Significant substance abuse/use (e.g., Illegal drugs and Alcohol) defined as any ongoing (i.e., at least once a month on more than 2 occasions) use of alcohol or any illegal substance use.
(n) suspected diagnosis of PANDAS type OCD or current PANDAS diagnosis - Children will be referred to private psychiatrist for management as CBT is contraindicated for these youth.

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=40 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 attrition, which is generally low based on \previous trials (0-5% attrition).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/08/2015
Date of last participant enrolment
Anticipated
1/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 9872 0
4222 - Griffith University

Funding & Sponsors
Funding source category [1] 291530 0
Government body
Name [1] 291530 0
National Health and Medical Research Council
Country [1] 291530 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] 290211 0
Individual
Name [1] 290211 0
Associate Professor Allison Waters
Address [1] 290211 0
School of Applied Psychology Griffith University 176 Messines Ridge Road Mt Gravatt Queensland 4122
Country [1] 290211 0
Australia
Secondary sponsor category [2] 290212 0
Individual
Name [2] 290212 0
Professor Jennifer Hudson
Address [2] 290212 0
Centre for Emotional Health
Building C3A, Level 7
Department of Psychology
Macquarie University
North Ryde
NSW 2109
Country [2] 290212 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293071 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 293071 0
Ethics committee country [1] 293071 0
Australia
Date submitted for ethics approval [1] 293071 0
11/11/2014
Approval date [1] 293071 0
20/11/2014
Ethics approval number [1] 293071 0
PSY/D8/14/HREC

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

Contacts
Principal investigator
Name 58090 0
Dr Lara Farrell
Address 58090 0
School of Applied Psychology, Menzies Health Institute QLD, Gold Coast Campus Griffith University Parklands Drive QLD 4222
Country 58090 0
Australia
Phone 58090 0
+61756788224
Fax 58090 0
+61756788291
Email 58090 0
l.farrell@griffith.edu.au
Contact person for public queries
Name 58091 0
Lara Farrell
Address 58091 0
School of Applied Psychology, Menzies Health Institute QLD, Gold Coast Campus Griffith University Parklands Drive QLD 4222
Country 58091 0
Australia
Phone 58091 0
+61756788224
Fax 58091 0
+61756788291
Email 58091 0
l.farrell@griffith.edu.au
Contact person for scientific queries
Name 58092 0
Lara Farrell
Address 58092 0
School of Applied Psychology, Menzies Health Institute QLD, Gold Coast Campus Griffith University Parklands Drive QLD 4222
Country 58092 0
Australia
Phone 58092 0
+61756788224
Fax 58092 0
+61756788291
Email 58092 0
l.farrell@griffith.edu.au

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
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Farrell, L. J., Waters, A. M., Tiralongo, E., Math... [More Details]

Documents added automatically
No additional documents have been identified.