None listed
Conditions
Brief summary
This research aims to provide preliminary data on a randomised controlled treatment trial for treatment refractory childhood obsessive-compulsive disorder (OCD) – that is, children and adolescents with OCD who continue to suffer disability even after first-line evidence-based treatment. Treatment evaluated in this study will be 5 (+3) sessions augmented behaviour therapy, specifically intensive exposure and response prevention, with D-Cycloserine – 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. This drug is yet to be investigated in a sample of children and youth with OCD.
Interventions
D-Cycloserine and Exposure Therapy versus Pill Placebo and Exposure Therapy. Participants are given 9 weekly 90 minute sessions (once per week) of individual cognitive-behaviour therapy (CBT; involving psychoeducation, relaxation training, cognitive therapy and exposure therapy). Five sessions involve intensive 90 minute exposure therapy (sessions 4 through 8; involving assisting participants to systematically adn gradually face theirs fears whilst resisting any ritualising). One group of partic
D-Cycloserine and Exposure Therapy versus Pill Placebo and Exposure Therapy. Participants are given 9 weekly 90 minute sessions (once per week) of individual cognitive-behaviour therapy (CBT; involving psychoeducation, relaxation training, cognitive therapy and exposure therapy). Five sessions involve intensive 90 minute exposure therapy (sessions 4 through 8; involving assisting participants to systematically adn gradually face theirs fears whilst resisting any ritualising). One group of participants receives D-Cycloserine (either 25mg or 50 mg depending on weight) before each of the 5 exposure therapy sessions. Each dose is given orally in capsule form 1 hour before each of exposure therapy sessions.
Sponsors
Dr Lara Farrell
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. primary diagnosis of OCD with score of at least 19 on CYBOCS at pre- (moderate range); 2. child meets treatment resistant criteria; 3. if taking a selective-serotonin reuptake inhibitor (SSRI) medication, dose must be stable for one-month prior to study entry and remain unchanged.
Exclusion criteria
Exclusion criteria for participation include: 1. organic mental disorder; 2. other medications that are contraindicated with D-Cycloserine (DCS); 3. pregnancy (will be screened for and if sexually active be required to use birth control); 4. psychosis; 5. pervasive developmental disorder; 6. history of seizure; 7. history other serious medical condition that would be contraindicated with DCS (ie., cardiovascular, liver, kidney, respiratory etc); 8. serious suicidal risk; 9. concurrent psychotherapy; 10. current diagnosis of tuberculosis (TB); 11. currently taking medication that lowers seizure threshold (ie., clozapine); 12. impaired intelligence (IQ; likely < 70).
Outcome results
None listed