A pilot study of D-cycloserine-augmented cognitive behavioural therapy (CBT) with exposure therapy in adolescents with obsessive-compulsive disorder (OCD)

ISRCTN ISRCTN70977225
DOI https://doi.org/10.1186/ISRCTN70977225
Secondary identifying numbers RAA2008-014
Submission date
22/12/2008
Registration date
05/02/2009
Last edited
25/11/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration and not expected to be available in the future

Contact information

Dr Isobel Heyman
Scientific

Department of Child and Adolescent Psychiatry - PO85
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom

Phone +44 (0)20 3228 5222
Email i.heyman@iop.kcl.ac.uk

Study information

Study designSingle-centre double-blind randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised double-blind placebo-controlled pilot study of D-cycloserine-augmented exposure therapy in adolescents with obsessive-compulsive disorder
Study objectivesThe 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(s)Kings College Hospital Research Ethics Committee (REC) gave approval in December 2008 (ref: 08/H0808/203)
Health condition(s) or problem(s) studiedObsessive-compulsive disorder
InterventionThe 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)D-cycloserine
Primary outcome measureChildren'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 measures1. 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 study start date01/02/2009
Completion date28/02/2010

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit12 Years
Upper age limit18 Years
SexBoth
Target number of participants24, with 12 in each arm of the trial
Key inclusion criteria1. 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)
Key exclusion criteria1. 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)
Date of first enrolment01/02/2009
Date of final enrolment28/02/2010

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Child and Adolescent Psychiatry - PO85
London
SE5 8AF
United Kingdom

Sponsor information

Institute of Psychiatry, Kings College London (UK)
Research organisation

c/o Professor Peter McGuffin
Dean's Office, PO 01
De Crespigny Park
London
SE5 8AF
United Kingdom

Website http://www.iop.kcl.ac.uk
ROR logo "ROR" https://ror.org/0220mzb33

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre for Mental Health (ref: PAXKAYI)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/01/2014 Yes No
HRA research summary 28/06/2023 No No