Factors Influencing Research Drug Trials in Adolescents With Anorexia Nervosa

Department of Paediatrics, Children's Hospital of Eastern Ontario/University of Ottawa, Ottawa, Ontario, Canada.
Eating disorders (Impact Factor: 1.48). 05/2010; 18(3):210-7. DOI: 10.1080/10640261003719468
Source: PubMed


This study examined factors that contributed to patient's eligibility and participation in a randomized controlled trial involving olanzapine for the adjunctive treatment of anorexia nervosa (AN). Factors involving patient eligibility and willingness to participate were systematically recorded for all patients approached to participate. Of the 92 patients that were assessed and treated over the study timeframe, only 27 patients (29%) met full criteria for inclusion, of which just 7 enrolled (26%). The most common reasons for study refusal related to fears associated with medication effects and refusal to consider medication as a treatment option (70%). Factors affecting recruitment in psychopharmacological studies involving AN in youth are discussed.

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    • "Our hope is that this study will provide a template for future studies, which may include the follow up of this cohort, as well as multicentre collaboration examining the efficacy and utility of psychotropic medication in managing paediatric EDs, with larger samples and a prospective design. Given the difficulty of conducting large randomised controlled trials of medication in this patient population [55], reports of actual prescribing practices, medication safety, and treatment outcomes in a naturalistic setting are of value. Understanding the prevalence and indications of psychotropic use is essential to considering their place in clinical practice and implications for service provision, including treatment and safety monitoring. "
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    ABSTRACT: Background To describe the rates, indications, and adverse effects of psychotropic drug prescription in a specialist tertiary hospital child and adolescent eating disorder service. Methods Retrospective case note study of all active eating disorder patients (N = 115) over the period of treatment from referral to time of study (M = 2 years), covering patient demographics, clinical characteristics, drug prescriptions, indications, and adverse effects. Results Psychotropic drugs were prescribed in 45% of cases, most commonly antidepressants (41%), followed by anxiolytics (29%) and antipsychotics (22%), with 8% initiated before referral to the specialist eating disorder program. Common indications were depressed mood, agitation, anxiety, and insomnia. Patient clinical severity and complexity was associated with prescribing. Adverse effects, mostly minor, were recorded in 23% of antidepressant prescriptions, 39% of antipsychotic prescriptions, and 13% of anxiolytic prescriptions. Second generation antipsychotic prescription was associated with subsequent new onset binge eating, in this preliminary observational study. Self-harm by overdose of psychotropics occurred in 11% of patients prescribed medication. Conclusions Psychotropic medications were frequently prescribed to adolescent eating disorder patients to treat distressing symptoms. Prospective randomised controlled trials to clarify efficacy and safety are needed. Given the difficulties of conducting clinical trials in this population, services are encouraged to monitor and audit medication safety and efficacy in everyday practice, and to report their findings.
    International Journal of Eating Disorders 08/2013; 1(1):27. DOI:10.1186/2050-2974-1-27 · 3.13 Impact Factor
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    • "A recent cross-sectional community population study estimated that overall psychopharmacologic medication use in adolescents diagnosed with any ED (19.3%) is approximately equivalent to that in the treatment of mood disorders (19.7%) [17]. To date, there have been few medication trials in adolescent patients with restrictive ED, and these trials have not demonstrated benefit in sustaining weight recovery [16,18e20], but they are limited by small size, problems with recruitment, high drop-out rates, and short duration [12] [20]. "
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    ABSTRACT: Psychopharmacologic medications are often prescribed to patients with restrictive eating disorders (EDs), and little is known about the frequency of use in adolescents. We examined the use of psychopharmacologic medications in adolescents referred for treatment of restrictive ED, potential factors associated with their use, and reported psychiatric comorbidities. Retrospective data from the initial and 1-year visits were collected for patients referred for evaluation of restrictive ED at 12 adolescent-based ED programs during 2010 (Group 1), including diagnosis, demographic information, body mass index, prior treatment modalities, and psychopharmacologic medications. Additional data regarding patients' comorbid psychiatric conditions and classes of psychopharmacologic medications were obtained from six sites (Group 2). Overall, 635 patients met inclusion criteria and 359 had 1-year follow-up (Group 1). At intake, 20.4% of Group 1 was taking psychopharmacologic medication and 58.7% at 1 year (p ≤ .0001). White, non-Hispanic race (p = .020), and prior higher level of care (p < .0001) were positively associated with medication use at 1 year. Among Group 2 (n = 256), serotonin reuptake inhibitors/serotonin-norepinephrine reuptake inhibitors use was most common, and 62.6% had a reported psychiatric comorbidity. Presence of any psychiatric comorbidity was highly associated with medication use; odds ratio, 10.0 (5.6, 18.0). Adolescents with restrictive ED treated at referral centers have high rates of reported psychopharmacologic medication use and psychiatric comorbidity. As more than half of this referral population were reported to be taking medication, continued investigation is warranted to ensure the desired outcomes of the medications are being met. Copyright © 2015 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.
    Journal of Adolescent Health 02/2013; 52(2):S39. DOI:10.1016/j.jadohealth.2012.10.094 · 3.61 Impact Factor
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    • "Although not specifically coded in this study, patient fears concerning excessive weight gain (whether real or perceived) influenced initiation rates as well as rates and timing of drug discontinuation. Concerns associated with medication effects and refusal to consider medication as a treatment option have been cited as the most common reasons for patients to refuse participation in randomized controlled studies investigating olanzapine use as augmented treatment for AN (Norris et al. 2010). Although many published articles contain generic statements regarding tolerability, the degree to which patients are screened medically while on the medication is often not reported or is unclear. "
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    ABSTRACT: To examine assessment and treatment profiles of adolescent patients with anorexia nervosa and eating disorder not otherwise specified who received olanzapine as compared with an untreated matched sample. A retrospective, matched-groups comparison study was completed. Medical files of 86 female patients treated in the eating disorder program at the Children's Hospital of Eastern Ontario were examined. Patients treated with olanzapine were initially identified through chart review and then matched to a diagnosis, age, and, when possible, treatment group that served as the active comparator. Weight gain was examined in a sample of 22 inpatients. Patients treated with olanzapine displayed greater evidence of psychopathology and medical compromise at the time of first assessment compared with those not treated. Rate of weight gain was not statistically different between groups when olanzapine was started during inpatient admissions. Medication effect on eating disorder cognitions could not be assessed given the presence of multiple confounders relating to treatment. Notable side effects included sedation and dyslipidemia in 56% of patients. Despite our best attempts at matching olanzapine-treated subjects with a control sample, analysis revealed significant differences between groups, suggesting greater illness severity in those augmented with olanzapine. Given these inherent differences, we were unable to draw any firm conclusions regarding the potential efficacy of olanzapine. Factors associated with the prescription of adjunctive pharmacotherapy in this cohort appear to be linked to illness severity, acuity, and associated comorbidity. The observed side-effect profile indicates the need for more consistent predrug screening and for closer monitoring during treatment.
    Journal of child and adolescent psychopharmacology 06/2011; 21(3):213-20. DOI:10.1089/cap.2010.0131 · 2.93 Impact Factor
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