Clinical trial NCT00074815: Treatment of Obsessive Compulsive Disorder in Children
Official title: Treatment of Pediatric OCD for SRI Partial Responders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obsessive-Compulsive Disorder
Keywords: Child
Adolescent
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-12-22
Enrollment: 124
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine whether cognitive behavioral therapy delivered by either psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor treatment in children with obsessive compulsive disorder.

Detailed description: The vast majority of children with obsessive compulsive disorder (OCD) are given serotonin reuptake inhibitor (SRI) drugs as initial treatment. However, recommended doses of these medications leave many children with clinically significant residual symptoms. Health care experts typically recommend augmenting SRI treatment with cognitive behavioral therapy (CBT), yet this recommendation is seldom followed. This study will contrast two CBT augmentation strategies to continued medication management alone: CBT administered by a psychologist and instructional CBT (I-CBT)administered by a psychiatrist in the context of ongoing medication management.

All patients in the trial will be eligible to receive a full course of CBT by study end. Participants in this study will be randomly assigned to receive CBT, I-CBT or continued medication management. All participants will continue their SRI treatment for 12 weeks. After the 12-week treatment period, participants who received I-CBT or medication management alone and who remain symptomatic will be given CBT as will participants who are asymptomatic but relapse within 6 months after treatment. Assessments will be conducted at Weeks 0, 4, 8, and 12. Follow-up assessments will be conducted at 3 and 6 months post-treatment.

Eligibility criteria: Inclusion Criteria:

* DSM-IV Diagnosis of obsessive compulsive disorder
* CYBOCS total score greater than 16

Exclusion Criteria:

* Other primary or co-primary psychiatric disorder
* Pervasive developmental disorder or disorders, including Asperger's Syndrome
* Thought disorder
* Prior failed trial of cognitive-behavioral therapy
* Has pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) or maintenance antibiotic for obsessive-compulsive disorder
* Mental retardation
* Pregnancy

Primary outcomes:
measure: Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
timeFrame: Measured at baseline and Week 12.
Secondary outcomes:
measure: Child Obsessive -Compulsive Impact Scale (COIS)
timeFrame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
measure: Child Depression Inventory
timeFrame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
measure: Pediatric Adverse Event Rating Scale (PAERS)
timeFrame: Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Child and Family Study Center
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania, The Center for the Treatment and Study of Anxiety
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Duke University
name: John S March, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franklin ME, Sapyta J, Freeman JB, Khanna M, Compton S, Almirall D, Moore P, Choate-Summers M, Garcia A, Edson AL, Foa EB, March JS. Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial. JAMA. 2011 Sep 21;306(11):1224-32. doi: 10.1001/jama.2011.1344.
citation: Conelea CA, Selles RR, Benito KG, Walther MM, Machan JT, Garcia AM, Sapyta J, Morris S, Franklin M, Freeman JB. Secondary outcomes from the pediatric obsessive compulsive disorder treatment study II. J Psychiatr Res. 2017 Sep;92:94-100. doi: 10.1016/j.jpsychires.2017.04.001. Epub 2017 Apr 7.
citation: Conelea CA, Walther MR, Freeman JB, Garcia AM, Sapyta J, Khanna M, Franklin M. Tic-related obsessive-compulsive disorder (OCD): phenomenology and treatment outcome in the Pediatric OCD Treatment Study II. J Am Acad Child Adolesc Psychiatry. 2014 Dec;53(12):1308-16. doi: 10.1016/j.jaac.2014.09.014. Epub 2014 Oct 2.
citation: Freeman JB, Choate-Summers ML, Garcia AM, Moore PS, Sapyta JJ, Khanna MS, March JS, Foa EB, Franklin ME. The Pediatric Obsessive-Compulsive Disorder Treatment Study II: rationale, design and methods. Child Adolesc Psychiatry Ment Health. 2009 Jan 30;3(1):4. doi: 10.1186/1753-2000-3-4.