This competing continuation proposal, Treatment of Pediatric OCD, addresses an important problem in the management of pediatric OCD, namely partial response to initial treatment with a serotonin reuptake inhibitor(SRI). For most pediatric OCD patients treated in the community, the first line initial treatment is monotherapy with an SRI. Recommended doses of these medications leave the great majority of patients with clinically significant residual symptoms. While OCD experts typically recommend augmenting SRI partial responders with cognitive-behavior therapy (CBT), this recommendation is seldom followed. An alternative augmentation strategy widely used in community practice but considered second-line by OCD experts is to add an atypical neuroleptic, such as risperidone (RIS), to SRI monotherapy. Because CBT and augmenting medications may differ in relative benefit and in risk, it is Imperative to conduct a well-controlled comparison of these two augmentation strategies against a control condition in the same patient population. The proposed study, which will be conducted at Duke University (John March), University of Pennsylvania (Martin Franklin) and Brown University (Henrietta Leonard), will meet this vital public health objective. Specifically, using a volunteer sample of 135 youth (45/site) age 8-17 with a primary DSM-IV diagnosis of OCD partially responsive to SRI pharmacotherapy, we propose to conduct a 5 year outcome study that will evaluate the relative efficacy of augmentation with: (1) OCD-specific CBT; (2) risperidone (RIS); and (3) pill placebo (PBO). We propose a balanced 3 (site) x 3 (CBT, RIS, or PBO) x 4 (assessment point) 12-week comparison of the three conditions. At study exit, all participants will be given clinical recommendations regarding further treatment based on their clinical status and will be followed up naturalistically for 12 additional months. PBO non-responders at the end of acute treatment will be given a choice of open treatment with either CBT or RIS delivered at no cost by the study team; non-responders to CBT or RIS will receive the alternative treatment delivered at no cost by the study team or, if they prefer, will be referred for community treatment. Blind assessments will be conducted for all patients at weeks 0, 4, 8, 12 (Phase I); the IE but not the patient will be blind for assessments during naturalistic follow-up, which will be conducted at 3, 6, 9 and 12 months post treatment. By examining the relative benefit and risk of CBT and RIS augmentation in the same patient population, the proposed study will provide an empirical basis for formulating practice guidelines. Health professionals then will be better able to advise their pediatric OCD patients regarding the management of partial response to SRls.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Research Project (R01)
Project #
5R01MH055121-07
Application #
6805624
Study Section
Special Emphasis Panel (ZMH1-ITV-D (01))
Program Officer
Vitiello, Benedetto
Project Start
2003-09-30
Project End
2008-07-31
Budget Start
2004-08-01
Budget End
2005-07-31
Support Year
7
Fiscal Year
2004
Total Cost
$387,527
Indirect Cost
Name
Duke University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Conelea, Christine A; Selles, Robert R; Benito, Kristen G et al. (2017) Secondary outcomes from the pediatric obsessive compulsive disorder treatment study II. J Psychiatr Res 92:94-100
Conelea, Christine A; Walther, Michael R; Freeman, Jennifer B et al. (2014) Tic-related obsessive-compulsive disorder (OCD): phenomenology and treatment outcome in the Pediatric OCD Treatment Study II. J Am Acad Child Adolesc Psychiatry 53:1308-16
Przeworski, Amy; Zoellner, Lori A; Franklin, Martin E et al. (2012) Maternal and child expressed emotion as predictors of treatment response in pediatric obsessive-compulsive disorder. Child Psychiatry Hum Dev 43:337-53
Flessner, Christopher A; Freeman, Jennifer B; Sapyta, Jeffrey et al. (2011) Predictors of parental accommodation in pediatric obsessive-compulsive disorder: findings from the Pediatric Obsessive-Compulsive Disorder Treatment Study (POTS) trial. J Am Acad Child Adolesc Psychiatry 50:716-25
March, John S (2011) The preschool ADHD Treatment Study (PATS) as the culmination of twenty years of clinical trials in pediatric psychopharmacology. J Am Acad Child Adolesc Psychiatry 50:427-30
March, John S (2011) Looking to the future of research in pediatric anxiety disorders. Depress Anxiety 28:88-98
Franklin, Martin E; Sapyta, Jeffrey; Freeman, Jennifer B et al. (2011) Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial. JAMA 306:1224-32
March, John S (2010) Commentary on 'Forum: use of antidepressants in children and adolescents'. Curr Opin Psychiatry 23:63-5
Garcia, Abbe Marrs; Sapyta, Jeffrey J; Moore, Phoebe S et al. (2010) Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I). J Am Acad Child Adolesc Psychiatry 49:1024-33; quiz 1086
March, J S; Vitiello, B (2009) Benefits exceed risks of newer antidepressant medications in youth--maybe. Clin Pharmacol Ther 86:355-7

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