F Randy Sallee

United BioSource Corporation, Chevy Chase, MD, USA

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Publications (6)25.94 Total impact

  • Article: Effects of clonidine and methylphenidate on family quality of life in attention-deficit/hyperactivity disorder.
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    ABSTRACT: The aim of this study was to determine the effect on family quality of life (QOL) of clonidine (CLON) and methylphenidate (MPH), used alone and in combination, in treating attention-deficit/hyperactivity disorder (ADHD). Two proxy QOL measures were used in a multicenter, double-blind, placebo-controlled 16-week trial of 122 children, ages 7-12 years, with ADHD. Children were randomized to one of four groups in which they received MPH, CLON, a combination of drugs, or placebo. QOL was measured with the Daily Hassles Scale and the Impact on Family Scale at baseline and at 16 weeks. In a general linear model repeated measures analysis, treatment groups improved over a 16-week period compared to placebo for Daily Hassles and Impact on Family, as well as in symptoms measured by the ADHD Rating Scale. QOL measures correlated moderately with efficacy and symptom measures. This study provides evidence that measures of QOL for the family are sensitive to pharmacological treatment of ADHD. The correlation pattern of the QOL measures with symptom and efficacy variables supported family QOL as a related but separate construct. Clonidine for Attention-Deficit/Hyperactivity Disorder Treatment Study (CAT) Trial Registry Name: Clinicaltrials.gov; ID Number, NCT00031395; URL, http://clinicaltrials.gov/ct/show/NCT00031395?order=8/ .
    Journal of child and adolescent psychopharmacology 10/2009; 19(5):511-7. · 2.59 Impact Factor
  • Article: Atomoxetine treatment of ADHD in children with comorbid Tourette syndrome.
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    ABSTRACT: This study examines changes in severity of tics and ADHD during atomoxetine treatment in ADHD patients with Tourette syndrome (TS). Subjects (7-17 years old) with ADHD (Diagnostic and Statistical Manual of Mental Disorders, DSM-IV) and TS were randomly assigned to double-blind treatment with placebo (n = 56) or atomoxetine (0.5-1.5 mg/kg/day, n = 61) for approximately 18 weeks. Atomoxetine subjects showed significantly greater improvement on ADHD symptom measures. Treatment was also associated with significantly greater reduction of tic severity on two of three measures. Significant increases were seen in mean pulse rate and rates of treatment-emergent nausea, decreased appetite, and decreased body weight. No other clinically relevant treatment differences were observed in any other vital sign, adverse event, laboratory parameter, or electrocardiographic measure. Atomoxetine is efficacious for treatment of ADHD and its use appears well tolerated in ADHD patients with comorbid TS.
    Journal of Attention Disorders 02/2008; 11(4):470-81. · 2.45 Impact Factor
  • Article: Atomoxetine treatment of ADHD in Tourette syndrome: reduction in motor cortex inhibition correlates with clinical improvement.
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    ABSTRACT: In children with attention deficit hyperactivity disorder (ADHD), clinical responses to the selective norepinephrine reuptake inhibitor atomoxetine (ATX) vary. We sought to determine in children with Tourette Syndrome (TS) whether clinical responses correlate with changes in short interval cortical inhibition (SICI). Fourteen children, ages 8-16, with ADHD and TS were treated open-label with ATX for one month. ADHD rating scale scores and SICI, measured with paired-pulse transcranial magnetic stimulation (pTMS), were assessed blindly and independently at treatment onset and one month later. Eleven children, mean ADHD rating scale scores 31.8 (SD 8.2) at onset, completed the study. After one month, ADHDRS changes ranged from an increase of 4 points to a decrease (improvement) of 24 points (mean change -9.6, SD 9.1). The changes in ADHDRS scores correlated with reduction in SICI (r=.74, p=.010). In children with TS, one month of atomoxetine treatment appears to induce correlated improvements in ADHD and, paradoxically, further reductions in cortical inhibition. PTMS-evoked SICI in ADHD with TS may be a biomarker of both deficiency and compensatory changes within cortical interneuronal systems. Effective atomoxetine treatment may augment compensatory processes and thereby reduce SICI.
    Clinical Neurophysiology 09/2007; 118(8):1835-41. · 3.41 Impact Factor
  • Article: Assessment of health state utilities for attention-deficit/hyperactivity disorder in children using parent proxy report.
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    ABSTRACT: This study used standard gamble (SG) utility interviews to assess parent preferences for health states of childhood attention-deficit/hyperactivity disorder (ADHD). Health state utilities are needed to calculate quality-adjusted life years (QALYs), a critical outcome measure in cost-effectiveness studies of new treatments. Parents (n = 43) of children diagnosed with ADHD completed SG utility interviews, rating their child's current health and 11 hypothetical health states describing untreated ADHD and ADHD treated with a stimulant or non-stimulant. Parents completed questionnaires on their children's symptoms and health-related quality of life (HRQL). Parents' SG rating of their child's current health state (mean of 0.74 on a utility scale ranging from 0 to 1) was significantly correlated with inattentive, hyperactive, and overall ADHD symptoms (r = 0.37, 0.36, and 0.40 respectively; p < 0.05) and psychosocial HRQL domains. Hypothetical health state utilities ranged from 0.48 (severe untreated ADHD) to 0.88 (effective and tolerable non-stimulant treatment). Comparisons between health states found expected differences between untreated mild, moderate, and severe ADHD health states. When both treatments were effective and tolerable, parents preferred the non-stimulant health state over the stimulant health state (p < 0.03). Results suggest that parent SG interviews are a feasible and useful method for obtaining utility scores that can be used in cost-effectiveness models of ADHD treatment.
    Quality of Life Research 04/2005; 14(3):735-47. · 2.30 Impact Factor
  • Article: Parent-proxy EQ-5D ratings of children with attention-deficit hyperactivity disorder in the US and the UK.
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    ABSTRACT: The symptoms of attention-deficit hyperactivity disorder (ADHD) are associated with impairment in multiple domains of health-related quality of life (HR-QOL). HR-QOL of children with ADHD has been assessed by relatively long multidimensional questionnaires. A review of the literature found no studies using the brief, well established EuroQoL Five-Dimension Questionnaire (EQ-5D) to estimate the HR-QOL of children with ADHD. The objective of this study was to assess the HR-QOL of children with ADHD using parents' responses to the proxy version of the EQ-5D. Participants were recruited in the midwestern US and in the vicinity of London, England. All parents completed three questionnaires: the EQ-5D proxy version; a measure of ADHD symptoms based on Diagnostic and Statistical Manual of Mental Disorders (4th Edition) [DSM-IV] criteria (the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV - Parent Version [ADHD-RS]); and either the Child Health Questionnaire - Parent Form 50 (CHQ-PF50) or the Child Health and Illness Profile - Child Edition (CHIP-CE), which are both generic multidimensional paediatric HR-QOL questionnaires. A total of 126 parents of children with ADHD participated in the study: 43 in the US and 83 in the UK. On the EQ-5D, participants indicated that 78.6% of their children experienced some problems or extreme problems performing usual activities, while 64.8% believed their child demonstrated some or extreme anxiety or depression. The mean EQ-5D index score was 0.75 and the mean visual analogue scale (VAS) score was 73.9. The EQ-5D index and VAS scores were found to be significantly correlated (p < 0.05) with several domains of the CHQ-PF50 (e.g. Mental Health, Self-Esteem, Family Activities, Psychosocial Summary Score) and the CHIP-CE (e.g. Satisfaction, Comfort, Academic Performance, Peer Relations). The EQ-5D scales were also significantly correlated with the ADHD-RS scales (p < 0.001). The proxy version of the EQ-5D, completed by parents, was able to detect impairment in children diagnosed with ADHD in the US and the UK. Furthermore, the EQ-5D index and VAS scores demonstrated construct validity among this sample through significant correlations with an ADHD symptom measure and previously validated multidimensional QOL instruments. These results suggest that parent-proxy EQ-5D ratings are feasible and valid for use as part of an overall health outcomes assessment in clinical studies of childhood ADHD.
    PharmacoEconomics 01/2005; 23(8):777-90. · 2.66 Impact Factor
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    Article: Once-daily atomoxetine treatment for children and adolescents with attention deficit hyperactivity disorder: a randomized, placebo-controlled study.
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    ABSTRACT: The authors assessed the efficacy of once-daily atomoxetine administration in the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD). In a double-blind study, children and adolescents with ADHD (N=171, age range=6-16 years) were randomly assigned to receive 6 weeks of treatment with either atomoxetine (administered once daily) or placebo. Outcomes among atomoxetine-treated patients were superior to those of the placebo treatment group as assessed by investigator, parent, and teacher ratings. The treatment effect size (0.71) was similar to those observed in previous atomoxetine studies that used twice-daily dosing. Parent diary ratings suggested that drug-specific effects were sustained late in the day. Discontinuations due to adverse events were low (less than 3%) for both treatment groups, and no serious safety concerns were observed. Once-daily administration of atomoxetine is an effective treatment for children and adolescents with ADHD.
    American Journal of Psychiatry 12/2002; 159(11):1896-901. · 12.54 Impact Factor