Efficacy of D-Cycloserine in combination with intensive exposure therapy in the treatment of obsessive compulsive disorder (OCD) in children
Dr Lara Farrell
80 participants
Aug 3, 2015
Interventional
Conditions
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.
Eligibility
Inclusion Criteria12
- (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 and ability to understand cognitive components of treatment -
- IQ will not be formally assessed in this project. Rather, this will be based on parent report of children’s general intellectual functioning during intake screening, and will involve asking the parent if they consider their child’s intellectual functioning to be at least in the low average range for children his/her age and they could understand general cognitive components of treatment.
- (e) willingness to cease any other concurrent psychotherapy related to OCD treatment
- (f) If taking psychotropic medication the following stabilization periods need to be completed prior to study entry
- If SSRI stable for 12 weeks prior to entering the study
- weeks stable for ADHD or atypical antipsychotics
- Dose increases need to be stable for 8 weeks
- Dose decrease needs to be stable for 8 weeks
- (g) willingness to keep mediation stable for the duration of the project, unless under medical advice to change dose or medication
Exclusion Criteria14
- (a) diagnosis of a Level 2 or 3 Autistic Spectrum Disorder based on newly revised DSM-V criteria
- (b) Current suicidal ideation and risk or/evidence of intent.
- Children with OCD are often extremely distressed by their condition, and whilst they may not be depressed and at risk of suicide based on our risk assessment, they may well express some thoughts of suicide. We routinely screen for risk, as does our independent Psychiatrist who screens all children, and as is current professional standards, deem them NOT at immediate risk if there is no intent - that is, if they have not thought about a plan to hurt themselves, and report no plan to actually act on their thoughts.
- (c) intellectual impairment or previously 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) epilepsy or history of seizure
- (i) history other serious medical condition that would be contraindicated with DCS (ie., cardiovascular, liver , kidney, respiratory etc),
- (j) concurrent psychotherapy related to OCD treatment
- (k) current diagnosis of Tuberculosis
- (l) currently taking clozapine, or medication that lowers seizure threshold
- (m) Significant substance abuse/use (e.g., Illegal drugs and Alcohol) defined as any ongoing (i.e., at least once a month on more than 2 occasions) use of alcohol or any illegal substance use.
- (n) suspected diagnosis of PANDAS type OCD or current PANDAS diagnosis - Children will be referred to private psychiatrist for management as CBT is contraindicated for these youth.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
D-cycloserine (DCS) augmented intensive exposure therapy versus pill placebo and intensive exposure therapy. Participants receive four individual intensive exposure therapy sessions. All intensive sessions will be 3 hours in duration. The first three intensive sessions will be spaced one week apart. The final booster intensive session will be one month after the third intensive session. The sessions involve assisting participants to systematically and gradually face their fears whilst resisting any ritualising. There will be two conditions. Half of participants will be given DCS immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions and half will be given a placebo pill immediately prior to starting their intensive cognitive-behavioural therapy treatment sessions. Participants will remain in the same dosing conditions across all treatment sessions. Particiapants will therefore have four doses of DCS or Placebo during the trial. 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 and supervised administration occurs by the therapy psychologist. The exposure therapy is delivered via trained psychologists.
Locations(1)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12616000473460