Efficacy of D-Cycloserine in combination with intensive exposure therapy in the treatment of obsessive compulsive disorder (OCD) in childre

Phase 2

Recruiting

• Conditions: Pediatric Obsessive Compulsive Disorder; Mental Health - Other mental health disorders

• Registration Number: ACTRN12616000473460
• Lead Sponsor: Dr Lara Farrell

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-04-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Inclusion criteria -
(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
* 6 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 Criteria

Exclusion criteria include -
(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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Obsessive Compulsive Diagnostic Severity (ADIS-P, CSR)[Pre-treatment, Post intensive, Post Booster, 3-month follow-up, 6 month follow-up];CYBOCS Total OCD severity[Pe-treatment, Post intensive, Post Booster, 3-month follow-up, 6 month follow-up];NIMH CGI Severity - Clinical Global Severity / Improvements[Pre-treatment, Post intensive, Post Booster, 3-month follow-up, 6 month follow-up]

Secondary Outcome Measures

Name	Time	Method
Target symptoms - top three symptoms child and parent reported and ratings of severity using 9-point Likert scale response (How severe has this symptom been in the past week)[Pre-treatment, Post Intensive, Post Booster, 3-month follow-up, 6 month follow-up];functional impairment - Child OCD Impact Scale (child and parent version)[Pre, Post-treatment, Post-Booster, 3 month follow-up];Anxiety - Multidimensional Anxiety Scale for Children (child report)[Pre-treatment, Post intensive, Post Booster, 3-month follow-up];Depression - Children's Depression Inventory[Pre-treatment, Post intensive, Post Booster, 3-month follow-u]