Placebo Response in Pediatric Anxiety Disorders: Results from the Child/Adolescent Anxiety Multimodal Study

Dobson, Eric T.; Mills, Jeffrey A.; Cornwall, Gary J.; Sakolsky, Dara; Birmaher, Boris; Compton, Scott N.; Piacentini, John; McCracken, James T.; Ginsburg, Golda S.; Kendall, Phillip C.; Walkup, John T.; Albano, Anne Marie; Rynn, Moira A.

doi:10.1089/cap.2016.0198

Cited by 31 publications

(22 citation statements)

References 41 publications

(45 reference statements)

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“…First, despite the general similarity of studies and our use of Bayesian hierarchical modeling to address the influence of exchangeability assumptions, unobserved factors may still affect the likelihood of AEs described in this report. Second, just as placebo response has received considerable attention in pediatric mood and anxiety disorders, the impact of placebo-related AEs, which affects our ability to quantify medication-related AEs, may vary as a result of patient expectation, clinician-specific factors (eg, experience with the disorder under study, expertise in the clinical trial population) 62 or trial design (eg, capture of AEs). In this regard, by choosing to examine OCD and anxiety disorders (rather than major depressive disorder), we have selected conditions with lower placebo response rates, [62][63][64] which may minimize the influence of high placebo response on AE reporting.…”

Section: Discussionmentioning

confidence: 99%

Antidepressant Tolerability in Pediatric Anxiety and Obsessive-Compulsive Disorders: A Bayesian Hierarchical Modeling Meta-analysis

Mills

Strawn

2020

Journal of the American Academy of Child & Adolescent Psych

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Objective: To compare adverse events (AEs), suicidality, and AE-related discontinuation in double-blind, placebo-controlled trials of pediatric patients with obsessive-compulsive disorder (OCD) and anxiety disorders treated with selective serotonin reuptake inhibitors (SSRIs) or serotoninnorepinephrine reuptake inhibitors (SNRIs). Method: MEDLINE, PubMed, Web of Science, PsycINFO, and Embase were searched for peer-reviewed, English-language articles from inception through March 1, 2019. We identified prospective, randomized SSRI and SNRI studies in patients <18 years of age with OCD or generalized, separation, or social anxiety disorders. AE rates were extracted and medication-placebo differences were examined using Bayesian hierarchical models, then posterior estimates of relative risk (RR) were determined for each AE by medication class and disorder. Results: Data were included from 18 trials (2,631 patients) and 7 medications (16 SSRI and 4 SNRI trials). Compared with placebo, SSRIs were associated with a greater likelihood of AE-related discontinuation (RR 3.59, credible interval [CrI] 0.019-0.067, p ¼ .0003), activation (RR 2.39, CrI 0.048-0.125, p ¼ .003), sedation (RR 1.94, CrI 0.035-0.157, p ¼ .002), insomnia (RR 1.93, CrI 0.040-0.149, p ¼ .001), abdominal pain (RR 1.53, CrI 0.032-0.164, p ¼ .005), and headache (RR 1.24, CrI 0.003-0.139, p ¼ .04). Activation was more common with SSRIs (versus SNRIs, RR 1.32, CrI 0.018-0.114, p ¼ .007). Neither SSRIs nor SNRIs were associated with treatment-emergent suicidality. Conclusion: In pediatric OCD and anxiety disorders, SSRIs (compared with placebo) are associated with distinct AEs and greater AE-related discontinuation, although their tolerability does not differ between anxiety disorders and OCD. Compared with SNRIs, SSRIs are more likely to produce activation. Class-related AEs are important for clinicians to consider, particularly in light of data suggesting differences in class-related efficacy. Whereas SSRIs are superior to SNRIs and the treatment of choice for anxiety, for youths who become activated on SSRIs, SNRIs might represent a good second choice given their reported efficacy and lower risk of activation.

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Section: Discussionmentioning

confidence: 99%

Antidepressant Tolerability in Pediatric Anxiety and Obsessive-Compulsive Disorders: A Bayesian Hierarchical Modeling Meta-analysis

Mills

Strawn

2020

Journal of the American Academy of Child & Adolescent Psych

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“…4 One of the clinical trials was excluded because it did not focus on pediatric trichotillomania, but instead on pediatric anxiety disorders more generally. 5 However, this study did have interesting results regarding pill-placebo response in anxiety disorders in children, notably that there is a placebo response within the first four weeks of treatment, after which placebo did not appear to have long term effects, whereas active treatment continued to show improvement with time. 5 This initial review of the seven clinical trials reduced the number of prospective studies to two.…”

Section: Related Literaturementioning

confidence: 80%

Behavioral therapy is a viable treatment option for children and adolescents with trichotillomania

Nesbitt

2020

Clin. Res. Pract.

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“…Second, no longitudinal assessment was conducted. A previous study of children with anxiety disorder reported that the placebo effect of therapeutic expectation was exerted within 4 weeks after therapy, but was not observed four to 8 weeks after therapy [ 31 ]. Third, in the current study, because we conducted a secondary analysis of our previous randomized controlled study, the number of participants performing resonant breathing at home was small and the behavioral effects were not fully evaluated.…”

Section: Discussionmentioning

confidence: 99%

Awareness of comfort immediately after a relaxation therapy session affects future quality of life and autonomic function: a prospective cohort study on the expectations of therapy

Hasuo

Kanbara

Sakuma

et al. 2018

BioPsychoSocial Med

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BackgroundHigh expectations regarding therapy are reported to have positive effects on future therapeutic course and related behavior. Some individuals are aware of feelings of comfort immediately after a relaxation therapy session.MethodsHeart rate variability biofeedback (HRV-BF) therapy using a relaxation technique called resonant breathing was administered to 44 family caregivers who felt burdened by their work caring for family members with cancer. We prospectively evaluated how the level of comfort participants were aware of immediately after an initial therapy session affected their expectations regarding the therapy, as well as future quality of life (QOL) and autonomic function. This study was a secondary analysis of a randomized, open-label study titled “Self-care system for family caregivers of cancer patients using resonant breathing with a portable home device”.ResultsAmong the participants, 56.8% were aware of a feeling of comfort immediately after an initial therapy session. Participants were then divided into two groups according to the presence or absence of their awareness of comfort. Expectation levels regarding the therapy were significantly increased in the awareness group after the therapy session (P = 0.003). No main effect between groups was observed for heart rate variability (HRV) during therapy (P = 0.949). Four weeks after the initial therapy session, QOL improved and HRV increased in the awareness group (P < 0.001).ConclusionsBetter outcomes in the awareness group were not associated with HRV during therapy. A feeling of comfort immediately after a therapy session may have positive effects on future QOL and autonomic function by raising participants’ expectations of the therapy.Trial registrationUMIN000021639. Registered 27 March 2016

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Placebo Response in Pediatric Anxiety Disorders: Results from the Child/Adolescent Anxiety Multimodal Study

Abstract: Pill placebo-related improvement occurs early in the course of treatment and both clinical factors and expectation predict this improvement. Additionally, probabilistic approaches may refine our understanding and prediction of pill placebo response.

Cited by 31 publications

References 41 publications

Antidepressant Tolerability in Pediatric Anxiety and Obsessive-Compulsive Disorders: A Bayesian Hierarchical Modeling Meta-analysis

Antidepressant Tolerability in Pediatric Anxiety and Obsessive-Compulsive Disorders: A Bayesian Hierarchical Modeling Meta-analysis

Behavioral therapy is a viable treatment option for children and adolescents with trichotillomania

Awareness of comfort immediately after a relaxation therapy session affects future quality of life and autonomic function: a prospective cohort study on the expectations of therapy

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