None listed
Conditions
Brief summary
The aim of the study is to examine whether D-Cycloserine can augment graded exposure therapy for children and adolescents with Obsessive Compulsive Disorder. D-Cycloserine is 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. The drug has recently been used to augment exposure therapy for children and adolescents with OCD. A secondary aim of the study is to systematically examine the timing of D-Cycloserine augmentation in a pediatric sample by comparing D-Cycloserine given immediately before or immediately after exposure therapy.
Interventions
D-cycloserine (DCS) augmented intensive exposure therapy versus pill placebo and intensive exposure therapy. Participants receive three individual intensive exposure therapy sessions. Each intensive session will be 3 hours in duration and spaced one week apart. The sessions involve assisting participants to systematically and gradually face their fears whilst resisting any ritualising. There will be three conditions examining the timing of dosing DCS. One third of participants will be given DCS
D-cycloserine (DCS) augmented intensive exposure therapy versus pill placebo and intensive exposure therapy. Participants receive three individual intensive exposure therapy sessions. Each intensive session will be 3 hours in duration and spaced one week apart. The sessions involve assisting participants to systematically and gradually face their fears whilst resisting any ritualising. There will be three conditions examining the timing of dosing DCS. One third of participants will be given DCS immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions and a placebo pill immediately following the session.One third of participants will be given a placebo pill immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions and DCS immediately following the session and one third of participants will be given a placebo pill immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions and a placebo pill immediately following the session.Participants will remain in the same dosing conditions across all treatment sessions.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. The exposure therapy is delivered via trained psychologists.
Sponsors
Dr Lara Farrell
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
Inclusion criteria will include - (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 (e) willingness to cease any other concurrent psychotherapy if taking psychotropic medication, dose must be stable for at least 12 weeks prior to study entry (g) if taking psychotropic medication, current dose must be stable for at least 6 weeks prior to entering trial (h) willingness to keep mediation stable for the duration of the project, unless under medical advice to change dose or medication
Exclusion criteria
Exclusion criteria include - (a) diagnosis of Autistic Spectrum Disorder (or pervasive developmental disorder) (b) suicidal ideation (c) intellectual impairment or 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) history of seizure (i) history other serious medical condition that would be contraindicated with DCS (ie., cardiovascular, liver , kidney, respiratory etc) (j) concurrent psychotherapy (k) current diagnosis of TB (l) currently taking medication that lowers seizure threshold (ie., clozapine);
Outcome results
None listed