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Secondary outcomes from the pediatric obsessive compulsive disorder treatment study II.

ABSTRACT: The Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II) investigated the benefit of serotonin reuptake inhibitor (SRI) augmentation with cognitive behavioral therapy (CBT). Primary outcomes focused on OCD symptom change and indicated benefit associated with a full course of CBT. Given that the majority of youth with OCD suffer from significant comorbid symptoms and impaired quality of life, the current study examined POTS II data for effects on secondary outcomes. Participants were 124 youth ages 7-17 years with a primary diagnosis of OCD who were partial responders to an adequate SRI trial. Participants were randomized to medication management, medication management plus instructions in cognitive behavioral therapy (CBT), or medication management plus full CBT. Acute effects on non-OCD anxiety, depression, inattention, hyperactivity, and quality of life were examined across treatment conditions. Improvement across treatment was observed for non-OCD anxiety, inattention, hyperactivity, and quality of life. Changes were generally significantly greater in the group receiving full CBT. Child-rated depression was not found to change. OCD-focused treatment lead to improvement in other areas of psychopathology and functioning. For youth who are partial responders to SRI monotherapy, augmentation with full CBT may yield the greatest benefit on these secondary outcomes.

Clinical trials registration

Treatment of Pediatric OCD for SRI Partial Responders, Clinicaltrials.gov Identifier: NCT00074815, http://clinicaltrials.gov/show/NCT00074815.

SUBMITTER: Conelea CA

PROVIDER: S-EPMC5500971 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Secondary outcomes from the pediatric obsessive compulsive disorder treatment study II.

Conelea Christine A CA Selles Robert R RR Benito Kristen G KG Walther Michael M MM Machan Jason T JT Garcia Abbe M AM Sapyta Jeffrey J Morris Sarah S Franklin Martin M Freeman Jennifer B JB

Journal of psychiatric research 20170407

The Pediatric Obsessive-Compulsive Disorder Treatment Study II (POTS II) investigated the benefit of serotonin reuptake inhibitor (SRI) augmentation with cognitive behavioral therapy (CBT). Primary outcomes focused on OCD symptom change and indicated benefit associated with a full course of CBT. Given that the majority of youth with OCD suffer from significant comorbid symptoms and impaired quality of life, the current study examined POTS II data for effects on secondary outcomes. Participants w ...[more]

PMID: 28412602

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Project description:ContextThe extant literature on the treatment of pediatric obsessive-compulsive disorder (OCD) indicates that partial response to serotonin reuptake inhibitors (SRIs) is the norm and that augmentation with short-term OCD-specific cognitive behavior therapy (CBT) may provide additional benefit.ObjectiveTo examine the effects of augmenting SRIs with CBT or a brief form of CBT, instructions in CBT delivered in the context of medication management.Design, setting, and participantsA 12-week randomized controlled trial conducted at 3 academic medical centers between 2004 and 2009, involving 124 pediatric outpatients between the ages of 7 and 17 years with OCD as a primary diagnosis and a Children's Yale-Brown Obsessive Compulsive Scale score of 16 or higher despite an adequate SRI trial.InterventionsParticipants were randomly assigned to 1 of 3 treatment strategies that included 7 sessions over 12 weeks: 42 in the medication management only, 42 in the medication management plus instructions in CBT, and 42 in the medication management plus CBT; the last included 14 concurrent CBT sessions.Main outcome measuresWhether patients responded positively to treatment by improving their baseline obsessive-compulsive scale score by 30% or more and demonstrating a change in their continuous scores over 12 weeks.ResultsThe medication management plus CBT strategy was superior to the other 2 strategies on all outcome measures. In the primary intention-to-treat analysis, 68.6% (95% CI, 53.9%-83.3%) in the plus CBT group were considered responders, which was significantly better than the 34.0% (95% CI, 18.0%-50.0%) in the plus instructions in CBT group, and 30.0% (95% CI, 14.9%-45.1%) in the medication management only group. The results were similar in pairwise comparisons with the plus CBT strategy being superior to the other 2 strategies (P < .01 for both). The plus instructions in CBT strategy was not statistically superior to medication management only (P = .72). The number needed-to-treat analysis with the plus CBT vs medication management only in order to see 1 additional patient at week 12, on average, was estimated as 3; for the plus CBT vs the plus instructions in CBT strategy, the number needed to treat was also estimated as 3; for the plus instructions in CBT vs medication management only the number needed to treat was estimated as 25.ConclusionsAmong patients aged 7 to 17 years with OCD and partial response to SRI use, the addition of CBT to medication management compared with medication management alone resulted in a significantly greater response rate, whereas augmentation of medication management with the addition of instructions in CBT did not.Trial registrationclinicaltrials.gov Identifier: NCT00074815.

Project description:Cognitive behavior therapy (CBT) has been established as efficacious for obsessive-compulsive disorder (OCD) among older children and adolescents, yet its effect on young children has not been evaluated sufficiently.To examine the relative efficacy of family-based CBT (FB-CBT) involving exposure plus response prevention vs an FB relaxation treatment (FB-RT) control condition for children 5 to 8 years of age.A 14-week randomized clinical trial (Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children [POTS Jr]) conducted at 3 academic medical centers between 2006 and 2011, involving 127 pediatric outpatients 5 to 8 years of age who received a primary diagnosis of OCD and a Children's Yale-Brown Obsessive Compulsive Scale total score of 16 or higher.Participants were randomly assigned to 14 weeks of (1) FB-CBT, including exposure plus response prevention, or (2) FB-RT.Responder status defined as an independent evaluator-rated Clinical Global Impression-Improvement scale score of 1 (very much improved) or 2 (much improved) and change in independent evaluator-rated continuous Children's Yale-Brown Obsessive Compulsive Scale total score. RESULTS Family-based CBT was superior to FB-RT on both primary outcome measures. The percentages of children who were rated as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale at 14 weeks were 72% for FB-CBT and 41% for FB-RT. The effect size difference between FB-CBT and FB-RT on the Clinical Global Impression-Improvement scale was 0.31 (95% CI, 0.17-0.45). The number needed to treat (NNT) with FB-CBT vs FB-RT was estimated as 3.2 (95% CI, 2.2-5.8). The effect size difference between FB-CBT and FB-RT on the Children's Yale-Brown Obsessive Compulsive Scale at week 14 was 0.84 (95% CI, 0.62-1.06).A comprehensive FB-CBT program was superior to a relaxation program with a similar format in reducing OCD symptoms and functional impairment in young children (5-8 years of age) with OCD.clinicaltrials.gov Identifier: NCT00533806.

Project description:Background: Many children and adults with Obsessive-Compulsive Disorder (OCD) fail to respond to first-line pharmacological and behavioral treatments. Glutamate dysfunction may contribute to the development of OCD. N-acetylcysteine (NAC), a glutamate modulating drug, has shown to be a promising agent in adults with OCD. Methods: We conducted a double-blind, placebo-controlled clinical trial from July 2012 to January 2017. Children ages 8 to 17 years with OCD were assigned to receive NAC (up to 2700 mg/day) or the matching placebo for a period of 12 weeks. Children were required to be on stable psychiatric treatment (both medication and therapy) but were not required to be treatment-refractory. The primary outcome was OCD symptom severity as measured by the Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS). We used linear mixed models to analyze the effect of NAC compared to placebo. Results: Due to poor recruitment and eventual expiration of the study medication, enrollment was stopped at 11 children out of a planned sample size of 40. Nonetheless, NAC was associated with significant reduction in CY-BOCS total score compared to placebo (Satterthwaite's test: t (37) = 2.36, p = 0.024) with effects separating from placebo beginning at week 8. Mean CY-BOCS total score decreased in the NAC group from 21.4 ± 4.65 at baseline to 14.4 ± 5.55 at week 12. In the placebo group, mean CY-BOCS total score remained unchanged (21.3 ± 4.65). In the NAC group, 1 out of 5 participants achieved >35% improvement in CY-BOCS total score, while none of the six patients in placebo group reached this improvement level. NAC and placebo were well tolerated. One mild adverse event was reported in each group. Conclusions: Our trial suggests that there may be some initial improvement in OCD symptom severity with NAC treatment. NAC was well tolerated in the study population. Future trials should employ multiple sites and have a larger study population to further confirm any benefits of NAC.

Dataset Information

Secondary outcomes from the pediatric obsessive compulsive disorder treatment study II.

Clinical trials registration

Publications

Secondary outcomes from the pediatric obsessive compulsive disorder treatment study II.

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