Contact information
Type
Scientific
Primary contact
Dr Isobel Heyman
ORCID ID
Contact details
Department of Child and Adolescent Psychiatry - PO85
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 3228 5222
i.heyman@iop.kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RAA2008-014
Study information
Scientific title
A randomised double-blind placebo-controlled pilot study of D-cycloserine-augmented exposure therapy in adolescents with obsessive-compulsive disorder
Acronym
Study hypothesis
The principal research objective is to establish the clinical effectiveness of D-cycloserine- (DCS-) augmented cognitive behavioural therapy (CBT) for children and adolescents with obsessive-compulsive disorder (OCD). Our hypothesis is that the effectiveness of CBT for OCD, and speed of recovery, can be improved by the addition of a small dose of DCS.
Ethics approval
Kings College Hospital Research Ethics Committee (REC) gave approval in December 2008 (ref: 08/H0808/203)
Study design
Single-centre double-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Obsessive-compulsive disorder
Intervention
The trial will consist of two arms. In the first arm, young people will receive cognitive behaviour therapy with a small dose of D-cycloserine (50 mg) given after sessions 3 to 12. In the second arm, young people will receive cognitive behaviour therapy with a placebo pill given after sessions 3 to 12.
Total duration of treatment in both arms is 14 weeks, and total duration of follow-up in both arms is 12 months, with follow-up evaluations planned to occur at 3 months, 6 months, and 12 months.
Intervention type
Drug
Phase
Not Applicable
Drug names
D-cycloserine
Primary outcome measure
Children's Yale Brown Obsessive Compulsive Scale (CYBOCS), a well-validated clinician administered measure of OCD severity. For each arm, this measure will be administered at the beginning of each session, and again at 3 months, 6 months and 12 months post-treatment.
Secondary outcome measures
1. Diagnosis of OCD as determined with:
1.1. The Anxiety Disorders Interview Schedule for DSM-IV (ADIS), the Child Obsessive-Compulsive Inventory (ChOCI), child and parent versions
1.2. The Strengths and Difficulties Questionnaire (SDQ), child and parent versions
1.3. The Beck Depression Inventory for Youth (BDI-Y)
1.4. The Depression Anxiety and Stress Scale (DASS) for parents
1.5. The Family Accommodation Scale (FAS)
2. Additional process variables include measures of trait anxiety (RCMAS), threat perception (CARBQ-C/P), subjective anxiety (SUDS ratings), behavioural avoidance tasks (BATs), physiological arousal (heart rate variability) and the Patient Exposure Adherence Scale (PEAS)
3. Behavioural Avoidance Task (BAT). A single task, single-step BAT will be administered. The task will be described to the child using standardised instructions. The BAT is an individually tailored task in which the young person is asked to expose him/herself to a situation that usually causes him/her significant distress or results in compulsive rituals.
4. Subjective units of distress (SUDS). Young people will be asked to rate their subjective distress at various time points during the BAT task, based on an 8-point Likert scale thermometer (0 = none to 8 = extreme).
5. Heart Rate Variability (HRV). HRV is a measure of the beat-to-beat variations in heart rate. It is calculated by analysing a time series of beat-to-beat intervals from a heart rate monitor. HRV is an indicator of autonomic arousal, and there is a known relationship between HRV and emotional arousal. HRV has been shown to be sensitive to the emotion of fear in most people. Therefore HRV will be used as a measure of physiological arousal in relation to the BAT task. HRV will be measured using a Polar heart rate monitor (FT80). A heart rate monitor consists of two elements: a chest strap transmitter and a wrist receiver (a sports watch). The chest strap has electrodes in contact with the skin to monitor electrical voltages in the heart.
6. Cognitive and Avoidant Response Bias Questionnaire - Child and Parent Versions (CARBQ-C/P). Threat perception and coping expectations in response to both generic, non-salient situations as well as to personally salient situations (i.e. situations that the young person perceives to be anxiety provoking) will be measured using the Cognitive and Avoidant Response Bias Questionnaire (CARBQ). It is also of interest to examine parents (mothers) levels of threat perception and coping expectations for their child.
Secondary outcome measures will be completed at 3 months, 6 months and 12 months post-treatment.
Overall trial start date
01/02/2009
Overall trial end date
28/02/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) diagnosis of OCD
2. Aged 12 to 18 years
3. Either sex
4. Any ethnicity, religious background or sexual orientation
5. Referred to the National and Specialist OCD Clinic at Maudsley Hospital
6. If on medication, this should be stable for 12 weeks and not be changed during the course of the trial
7. Provision of written informed consent (patient and carer)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
24, with 12 in each arm of the trial
Participant exclusion criteria
1. Current diagnosis of psychosis, current alcohol or substance abuse/dependence
2. English too poor to engage in treatment
3. Severe disabling neurological disorder
4. Medical contraindication to cycloserine, including epilepsy and porphyria
5. A diagnosed global learning disability or pervasive developmental disorder
6. Characteristics interfering with completion of treatment, e.g. life threatening or unstable medical illness
7. Pregnancy
8. Not suitable for CBT (selective mutism, lack of insight or motivation for change)
Recruitment start date
01/02/2009
Recruitment end date
28/02/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Child and Adolescent Psychiatry - PO85
London
SE5 8AF
United Kingdom
Sponsor information
Organisation
Institute of Psychiatry, Kings College London (UK)
Sponsor details
c/o Professor Peter McGuffin
Dean's Office
PO 01
De Crespigny Park
London
SE5 8AF
United Kingdom
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre for Mental Health (ref: PAXKAYI)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24262813
Publication citations
-
Results
Mataix-Cols D, Turner C, Monzani B, Isomura K, Murphy C, Krebs G, Heyman I, Cognitive-behavioural therapy with post-session D-cycloserine augmentation for paediatric obsessive-compulsive disorder: pilot randomised controlled trial., Br J Psychiatry, 2014, 204, 1, 77-78, doi: 10.1192/bjp.bp.113.126284.