School Phobia: A Therapeutic Trial with Clomipramine and Short-Term Outcome

Berney, Thomas P.; Kolvin, I.; Bhate, Surya; Garside, R. F.; Jeans, J; Kay, B. D.; Scarth, L. G.

doi:10.1192/bjp.138.2.110

Cited by 190 publications

(58 citation statements)

References 21 publications

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“…Results have been mixed, with some studies showing superiority to placebo (12,13) and others not (14)(15)(16). Owing to their risk of cardiac toxicity and potential anticholinergic side effects, tricyclics have recently fallen out of favour in the treatment of childhood anxiety disorders.…”

Section: Psychotropic Medication In Childhood Anxiety Disordersmentioning

confidence: 99%

Medicated Anxious Children: Characteristics and Cognitive-Behavioural Treatment Response

Liashko

Manassis

2003

Can J Psychiatry

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A nxiety disorders in children and adolescents are highly prevalent psychopathologies affecting as many as 10% of youth (1-3). These disorders are frequently associated with psychosocial difficulties, school difficulties, and risk for more serious conditions including depression, suicide, and substance abuse. The goals of treatment are to target overwhelming, incapacitating anxiety that interferes with functioning in social or academic spheres and to prevent a chronic Can J Psychiatry, Vol 48, No 11, December 2003 W 741 Objective: To determine whether individual and family characteristics of children with anxiety disorders who take psychotropic medications differ from those that are unmedicated and whether there is a differential response to cognitive-behavioural therapy (CBT). Method:Children ages 8 to 12 years (n = 102: 18 medicated, 84 unmedicated) were recruited in a specialized outpatient clinic over a 3-year period. All had a primary diagnosis of an anxiety disorder. Comparisons were done using t-tests for continuous measures and chi-square tests for discrete measures. Treatment-related changes were assessed using repeated measures analyses of variance.Results: Medicated and unmedicated groups did not differ by age, sex, socioeconomic status, or diagnostic profile. Initial ratings of anxiety symptoms, depressive symptoms, and global functioning were comparable. Greater family dysfunction and family frustration were reported in medicated children. With treatment, both groups improved symptomatically and showed improved family functioning. Families of medicated children showed a greater reduction in frustration than families of unmedicated children, whereas unmedicated children showed greater gains in global functioning. Conclusions:Initial family functioning of medicated children seems to show more disturbances. Both medicated and unmedicated children can benefit from CBT. Further studies of differential treatment effects for medicated and unmedicated children are indicated. Information on funding and support and author affiliations appears at the end of the article. Clinical Implications· Families of children with anxiety disorders who require medications may show higher rates of family dysfunction and family frustration. · Family dysfunction appears to improve with cognitive-behavioural therapy (CBT). · Even anxious children who require medications can benefit from CBT, although gains in global functioning may be more limited. Limitations· This was an exploratory, uncontrolled study without randomization. · Results were not corrected for number of comparisons. · Results must be replicated with the inclusion of more medicated children.

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Section: Psychotropic Medication In Childhood Anxiety Disordersmentioning

confidence: 99%

Medicated Anxious Children: Characteristics and Cognitive-Behavioural Treatment Response

Liashko

Manassis

2003

Can J Psychiatry

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“…Eight of the 14 studies were federally funded, 4 were industry funded, and funding data were unavailable for 2 of these studies (Simeon et al 1992;Berney 1981). The average number of sites per trial was 14 -20 and five trials (36%) were single-site studies.…”

Section: Characteristics Of Participants and Studies Includedmentioning

confidence: 99%

Placebo Response in Pediatric Anxiety Disorders: Implications for Clinical Trial Design and Interpretation

Dobson

2016

Journal of Child and Adolescent Psychopharmacology

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Objectives: The characterization and prediction of placebo response in clinical trials of youth with anxiety disorders have received little attention, despite the critical effects of placebo response rate on the success or failure of clinical trials. With this in mind, we sought to examine the factors that predict or influence placebo response in randomized controlled trials of youth with anxiety disorders. Methods: Prospective, randomized, parallel-group controlled trials of psychopharmacologic interventions in pediatric patients with anxiety disorders were identified using a search of PubMed/Medline (1966. Weighted least squares regression models and z-tests were utilized to examine the impact of continuous and categorical variables, respectively, on placebo response. These variables included demographic (e.g., age, percent white, percent female), clinical (e.g., baseline symptom severity), and trial characteristics (sample size, duration, funding). Finally, the relationship between the class of comparator medication and placebo response rate was examined using a multiple comparison for proportions test.Results: The analyses of data from 14 trials involving 2230 patients and 9 medications reveal that higher placebo response rates were associated with a greater number of study sites ( p = 0.013) and fewer patients per site ( p < 0.008), while placebo dropout rates increased with more recent publication ( p = 0.01) and were positively associated with the number of study visits ( p < 0.02). Lower placebo response rates were associated with federally funded studies (z = -4.61, p < 0.001), studies conducted in the United States (z = 1.81, p < 0.035), and with an increased likelihood of detecting a significant effect on the primary outcome (z = 4.58, p < 0.0001). Additionally, studies, in which the majority of patients (>60%) had a diagnosis of social anxiety disorder, exhibited lower placebo response rates ( p < 0.001). Finally, for trials, effect size has decreased over time ( p = 0.004). Conclusions: Important trial-specific factors affect placebo response and placebo dropout in youth with anxiety disorders and have pragmatic implications for the conduct and design of clinical trials and raise the possibility that limiting the number of sites while maximizing the number of patients per site could enhance the ability to detect medication-placebo differences.

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“…The only placebo-controlled clinical trial to evaluate clomipramine in children and adolescents with school refusal also showed similarity between its clinical response and the one observed with placebo (Berney et al 1981). In this study, subjects may have taken subdoses, as only low doses of clomipramine (40-75 mg/day) were used.…”

mentioning

confidence: 64%

“…The only (double-blind) treatment trial, with children with school refusal and neurotic disorder, failed to demonstrate any significant short-term effects of clomipramine. It is noteworthy, however, that subjects in this study had heterogeneous diagnoses and were submitted to small dose regimens (40-75 mg/ day) (Berney et al 1981). In contrast with the scarcity of studies with clomipramine in GAD, SAD, and SP, children and adolescents with another AD, obsessive-compulsive disorder (OCD), have long been successfully treated with this compound (Leonard et al 1989).…”

Section: Introductionmentioning

confidence: 99%

Comparison Among Clomipramine, Fluoxetine, and Placebo for the Treatment of Anxiety Disorders in Children and Adolescents

Costa

Morais²,

Zanetta³

et al. 2013

Journal of Child and Adolescent Psychopharmacology

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Objective: The purpose of this study was to test the efficacy of clomipramine and fluoxetine, controlled by placebo, and compare their action in children and adolescents with anxiety disorders. Method: Thirty subjects (ages 7-17 years), who were diagnosed with generalized anxiety disorder and/or separation anxiety disorder and/or social phobia, were submitted to a 12 week double-blind, randomized, placebo-controlled trial of clomipramine and fluoxetine. The instruments included: the Schedule for Affective Disorders and Schizophrenia, the Multidimensional Anxiety Scale for Children, the Children's Depression Inventory, the Clinical Global Impressions, and the Children's Global Assessment Scale. Results: All groups (clomipramine [n = 9], fluoxetine [n = 10], placebo [n = 11]) showed a significant improvement after 12 weeks of treatment. There were significant differences between the fluoxetine and placebo groups in some ratings of anxiety severity and impairment. No significant differences were observed between clomipramine and placebo groups or between fluoxetine and clomipramine groups. Conclusions: Treatment with placebo showed an unusual high response rate. Clomipramine showed similar efficacy compared with fluoxetine, although it was not superior to placebo.

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School Phobia: A Therapeutic Trial with Clomipramine and Short-Term Outcome

Cited by 190 publications

References 21 publications

Medicated Anxious Children: Characteristics and Cognitive-Behavioural Treatment Response

Medicated Anxious Children: Characteristics and Cognitive-Behavioural Treatment Response

Placebo Response in Pediatric Anxiety Disorders: Implications for Clinical Trial Design and Interpretation

Comparison Among Clomipramine, Fluoxetine, and Placebo for the Treatment of Anxiety Disorders in Children and Adolescents

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