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 |
| Protocol serial number | RAA2008-014 |
| Sponsor | Institute of Psychiatry, Kings College London (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre for Mental Health (ref: PAXKAYI) |
- 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
Plain English summary of protocol
Not provided at time of registration and not expected to be available in the future
Contact information
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 |
|---|---|
| i.heyman@iop.kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre double-blind randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A randomised double-blind placebo-controlled pilot study of D-cycloserine-augmented exposure therapy in adolescents with obsessive-compulsive disorder |
| Study objectives | 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(s) | Kings College Hospital Research Ethics Committee (REC) gave approval in December 2008 (ref: 08/H0808/203) |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | D-cycloserine |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Diagnosis of OCD as determined with: |
| Completion date | 28/02/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 24 |
| Key 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) |
| Key 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) |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 28/02/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SE5 8AF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |