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Biomedical subjects

Lawrence Scahill

Publications and source records attributed to Lawrence Scahill.

At least 37 records · Page 2Linked to original sources
PubMed2005

Challenges in evaluating psychosocial interventions for Autistic Spectrum Disorders.

In 2002, the National Institutes of Health sponsored a meeting concerning methodological challenges of research in psychosocial interventions in Autism Spectrum Disorders. This paper provides a summary of the presentations and the discussions that occurred during this meeting. Recommendations to federal and private agencies included the need for randomized clinical trials of comprehensive interventions for autism as the highest, but not the sole priority. Ongoing working groups were proposed to address psychosocial interventions with a focus on relevant statistics, standardized documentation and methods of diagnosis, development of outcome measures, establishment of standards in research; and the need for innovative treatment designs, including application of designs from other research areas to the study of interventions in ASD.

Autistic Disorder↗
PubMed2005

Selective serotonin reuptake inhibitors for children and adolescents with major depression: current controversies and recommendations.

Recent warnings about potential serious adverse effects with the selective serotonin reuptake inhibitors in children and adolescents with depression raises questions about the risk-benefit ratio of these drugs in this population. Published safety and efficacy trials of SSRIs for the treatment of youth with depression are critically reviewed. These data were augmented by information from regulatory hearings in 2003-2004 and selected open-label reports. Based on this review, recommendations for medication treatment and monitoring of children and adolescents with major depression on SSRIs are provided. Emerging data from several clinical trials show that the SSRIs provide moderate benefits for youth with depression. In addition, SSRI treatment may be associated with increased risk of behavioral activation, self-harm, and suicidal ideation. Appropriate use of the SSRIs in children and adolescents requires careful diagnostic assessment, evaluation of comorbidity, and close monitoring, especially early in treatment.

Adolescent↗
PubMed2005

Acute and long-term safety and tolerability of risperidone in children with autism.

Treatment-emergent adverse events (AEs) were monitored during an 8-week, double-blind, placebo-controlled trial of risperidone (0.5-3.5 mg/day) in 101 children and adolescents with a lifetime diagnosis of autistic disorder. In addition, 37 placebo nonresponders received open-label risperidone for another 8 weeks. Of all the risperidone responders (n=65), 63 entered an open extension of another 16 weeks (6 months total risperidone exposure), and 32 of them were rerandomized to either continued risperidone therapy (n=16) or gradual replacement with placebo (n=16) over 8 weeks. We collected the following measures of safety and tolerability: (1) laboratory blood assessments (CBC with differential, electrolytes, and liver function tests) and urinalyses, (2) vital signs, (3) Side Effects Review of AEs thought to be associated with risperidone, (4) sleep records, (5) Simpson Angus Neurological Rating Scale (SARS), (6) Abnormal Involuntary Movement Scale (AIMS), and (7) height and weight. No clinically significant changes were found on the lab tests. During the 8-week acute trial, the most common AEs on the Side Effects Review, scored as moderate or higher, were as follows (placebo and risperidone, respectively): Somnolence (12% and 37%), enuresis (29% and 33%), excessive appetite (10% and 33%), rhinitis (8% and 16%), difficulty waking (8% and 12%), and constipation (12% and 10%). "Difficulty falling asleep" and anxiety actually favored the risperidone condition at statistically significant levels. The same AEs tended to recur through 6 months of treatment, although often at reduced levels. Using Centers for Disease Control (CDC) standardized scores, both weight and body mass index (BMI) increased with risperidone during the acute trial (0.5 and 0.6 SDs, respectively, for risperidone; 0.0 and 0.1 SDs, respectively, for placebo) and into open-label extension (0.19 and 0.16 SDs, respectively), although the amount of gain decelerated with time. Extrapyramidal symptoms, as assessed by the SARS, were no more common for drug than placebo, although drooling was reported more often in the risperidone group. There were no differences between groups on the AIMS. Two subjects had seizures (one taking placebo), but these were considered unrelated to active drug. Most AEs were mild to moderate and failed to interfere with therapeutic changes; there were no unanticipated AEs. The side effects of most concern were somnolence and weight gain.

Adolescent↗
PubMed2005

Research knowledge among parents of children participating in a randomized clinical trial.

OBJECTIVE: Parental permission is required for child research, but parents' understanding of research aims and procedures has not been well documented. Parental research knowledge was assessed during a clinical trial in autism. METHOD: Parents of 101 children (age 5-17 years) with autism participating in a placebo-controlled trial of risperidone were given a questionnaire at the end of the study. RESULTS: Of the 95 parents completing the questionnaire, 99% knew of possible placebo assignment and that testing the medication efficacy was the main purpose of the investigators; 96% to 98% knew that research involved both risks and potential benefits, identified the study medication, and knew of their right to withdraw at any time; 90% to 95% knew of the medication's main side effects; 87% reported having been informed of possible alternatives to research participation; and 72% were aware that treatment was randomly assigned (whereas 27% reported that treatment was chosen based on individual needs to ensure best care). Parents with a college degree were more likely to recognize the random nature of treatment assignment. CONCLUSIONS: Overall, parents were highly knowledgeable of the main research components. About one fourth, however, seemed unaware that treatment was randomly determined and not personalized, suggesting that therapeutic misconception may affect some otherwise well-informed parents.

Adolescent↗
PubMed2005

Electrocardiographic changes in children and adolescents treated with ziprasidone: a prospective study.

OBJECTIVE: To assess the electrocardiographic safety profile of low-dose ziprasidone (< or =40 mg/day) among pediatric outpatients treated for up to 6 months. METHOD: This was a prospective, open-label trial involving 20 subjects with a mean age of 13.2 +/- 3.0 years. Subjects received a mean ziprasidone dose of 30 +/- 13 mg/day and were followed for 4.6 +/- 2.0 months, receiving a median of nine electrocardiograms each (range 2-11; total, 176). RESULTS: There were statistically significant changes from baseline to peak values in heart rate, PR, and QTc intervals, but not in QRS complex width. The mean QTc prolongation was 28 +/- 26 milliseconds and not related to dose (r = 0.16, p = .07). The peak QTc of three subjects reached or exceeded 450 milliseconds; one subject experienced a 114-millisecond prolongation. There was poor agreement (kappa = 0.25) between automated and manual identification of long QTc intervals (> or =440 milliseconds). CONCLUSIONS: These preliminary findings, occurring at doses low by current treatment standards, suggest that close electrocardiographic monitoring is warranted when prescribing ziprasidone to children, particularly at higher doses or when combined with other QTc-prolonging agents.

Adolescent↗
PubMed2005

Long-term effects of risperidone in children with autism spectrum disorders: a placebo discontinuation study.

OBJECTIVE: The short-term benefit of risperidone in ameliorating severe disruptive behavior in pediatric patients with autism spectrum disorders is well established; however, only one placebo-controlled, long-term study of efficacy is available. METHOD: Thirty-six children with an autism spectrum disorder (5-17 years old) accompanied by severe tantrums, aggression, or self-injurious behavior, started 8-week open-label treatment with risperidone. Responders (n = 26) continued treatment for another 16 weeks, followed by a double-blind discontinuation (n = 24; two patients discontinued treatment because of weight gain) consisting of either 3 weeks of taper and 5 weeks of placebo only or continuing use of risperidone. Relapse was defined as a significant deterioration of symptoms based on clinical judgment and a parent questionnaire. RESULTS: Risperidone was superior to placebo in preventing relapse: this occurred in 3 of 12 patients continuing on risperidone versus 8 of 12 who switched to placebo (p = .049). Weight gain, increased appetite, anxiety, and fatigue were the most frequently reported side effects. CONCLUSIONS: This study indicates the effectiveness of risperidone during a period of several months, reducing disruptive behavior in about half of the children with autism spectrum disorders. The results provide a rationale for the continuing use of risperidone beyond 6 months, although considerable weight gain can limit the use of this agent.

Adolescent↗
PubMed2005

Assessment of the integrity of study blindness in a pediatric clinical trial of risperidone.

OBJECTIVE: Controlled clinical trials in pediatric psychopharmacology rely on blinded parents and clinical evaluators for outcome data, but little is known about the success of the masking procedures. The blindness of clinical evaluators and parents was examined in a clinical trial of risperidone in autism. METHODS: Clinical evaluators and parents were asked to guess individual treatment assignments at the end of an 8-week placebo-controlled trial of risperidone in children (aged 5-17 years) with autism. Clinical evaluators did not have access to adverse event data. RESULTS: The rates of correctly guessing individual treatment assignment (risperidone or placebo) were significantly greater than chance for both clinical evaluators and parents (P < 0.001). Clinical evaluators associated improvement with attribution to risperidone, and lack of improvement with attribution to placebo, in both the risperidone and placebo treatment arms. Parents associated improvement with attribution to risperidone only in the placebo treatment arm. Parents reported that adverse events influenced their guesses, but presence of adverse events was not associated with correctness of guess. CONCLUSION: Improvement was associated with attribution to active treatment regardless of actual treatment assignment, and adverse events did not appear to be a threat to study blindness.

Adolescent↗
PubMed2005

Adaptive, emotional, and family functioning of children with obsessive-compulsive disorder and comorbid attention deficit hyperactivity disorder.

OBJECTIVE: The purpose of the study was to examine adaptive, emotional, and family functioning in a well-characterized group of children and adolescents with obsessive-compulsive disorder (OCD) and to evaluate the influence of comorbid attention deficit hyperactivity disorder (ADHD) on the levels of impairment in various functional domains. METHOD: The study group included 287 children and adolescents (191 boys, 96 girls) ages 7-18 years. Fifty-six subjects had a diagnosis of OCD only, 43 had both OCD and ADHD, 95 had ADHD, and 93 were unaffected comparison children. Best estimate DSM-IV diagnoses were assigned on the basis of structured interviews and clinical ratings. The children's functioning was evaluated with a comprehensive battery of well-established, standardized measures, including the Vineland Adaptive Behavior Scales, parents' ratings of social and family functioning, and children's self-reports of emotional adjustment. RESULTS: The children with OCD only were more impaired than were unaffected comparison subjects in most areas of adaptive functioning and emotional adjustment. Children with OCD plus ADHD had additional difficulties in social functioning, school problems, and self-reported depression. Impairment in daily living skills, reduced number of activities, and self-reported anxiety were uniquely associated with the diagnosis of OCD. Family dysfunction was associated with ADHD but not with OCD. CONCLUSIONS: Children and adolescents with OCD are impaired in multiple domains of adaptive and emotional functioning. When comorbid ADHD is present, there is an additional burden on social, school, and family functioning.

Adaptation, Psychological↗
PubMed2005

Risperidone for the core symptom domains of autism: results from the study by the autism network of the research units on pediatric psychopharmacology.

OBJECTIVE: Risperidone has been found efficacious for decreasing severe tantrums, aggression, and self-injurious behavior in children and adolescents with autistic disorder (autism). The authors report on whether risperidone improves the core symptoms of autism, social and communication impairment and repetitive and stereotyped behavior. METHOD: The database from an 8-week double-blind, placebo-controlled trial (N=101) and 16-week open-label continuation study (N=63) of risperidone for children and adolescents with autism was used to test for drug effects on secondary outcome measures: scores on the Ritvo-Freeman Real Life Rating Scale, the Children's Yale-Brown Obsessive Compulsive Scale, and the maladaptive behavior domain of the Vineland Adaptive Behavior Scales. RESULTS: Compared to placebo, risperidone led to a significantly greater reduction in the overall score on the Ritvo-Freeman Real Life Rating Scale, as well as the scores on the subscales for sensory motor behaviors (subscale I), affectual reactions (subscale III), and sensory responses (subscale IV). No statistically significant difference was observed, however, on the subscale for social relatedness (subscale II) or language (subscale V). Risperidone also resulted in significantly greater reductions in scores on the Children's Yale-Brown Obsessive Compulsive Scale and Vineland maladaptive behavior domain. This pattern of treatment response was maintained for 6 months. CONCLUSIONS: Risperidone led to significant improvements in the restricted, repetitive, and stereotyped patterns of behavior, interests, and activities of autistic children but did not significantly change their deficit in social interaction and communication. Further research is necessary to develop effective treatments for the core social and communicative impairments of autism.

Adolescent↗
PubMed2005

Public health significance of tic disorders in children and adolescents.

In conclusion, data from community surveys suggest that tic disorders, including TS, exist on a spectrum from transient to persistent, multiple motor, and vocal tics that interfere with activities of daily living. The presence of isolated and transitory tics is common and appears to be of minimal consequence. On the other hand, persistent tics, even mild tics, appear to be associated with ADHD, disruptive behavior, and learning problems (though not necessarily formal learning disability). The presence of ADHD with tics increases the likelihood of disruptive behavior and learning problems, but learning problems can be observed in community samples of children with tic disorders, even in the absence of ADHD. To date, few studies have clearly defined the nature of the learning problems in children with tic disorders. Nonetheless, the data do suggest that having chronic tics is associated with impairment independent of ADHD. Community samples and recent investigations in clinical samples confirm that the presence of ADHD predicts greater disability than that associated with tic disorders alone.

Adolescent↗
PubMed2005

Diagnosis and evaluation of pervasive developmental disorders.

Accurate diagnosis and appropriate treatment of pervasive developmental disorders (PDDs), including autistic disorder, Asperger's disorder, and pervasive developmental disorder not otherwise specified, are necessary to ensure the best possible outcomes for children with these disorders. In the past, it was not uncommon for children with PDDs to wait several years from the time of parental recognition of developmental delay to the determination of the correct diagnosis and initiation of treatment. Increased awareness of PDDs and the availability of better assessment tools have improved the detection of these conditions in children. A wide variety of standardized diagnostic checklists, interviews, and observational measures are available to assist the clinician in making an accurate PDD diagnosis. A comprehensive evaluation also establishes a baseline of adaptive functioning and problematic behavior, which is essential for subsequent assessment of progress. This article discusses the differential diagnosis and evaluation of PDDs, focusing on the various assessment tools. The elements of a contemporary diagnostic evaluation and behavioral assessment are presented. The application of discretionary evaluations for special situations are also introduced.

Adult↗
PubMed2005

An open-label, prospective study of guanfacine in children with ADHD and tic disorders.

OBJECTIVES: To evaluate the efficacy and safety of guanfacine in children with attention-deficit hyperactivity disorder (ADHD) and tic disorders. MATERIAL AND METHOD: Twenty-five medication-free subjects (23 males and 2 females), aged 7-16 (mean = 10.6 +/- 2.0) years participated in an 8-week open-label guanfacine study. Subjects were recruited from a specialty clinic for children with tic disorders over a four-year period. Eligibility criteria included presence of ADHD (any type), a tic disorder (any type), and being medication free for two weeks. Outcome measures included the Hyperactivity Index of the Conners Parent Questionnaire, the teacher-rated ADHD Rating Scale, and the Yale Global Tic Severity Scale (YGTSS). RESULTS: All subjects met criteria for ADHD (combined type N = 22; predominantly inattentive type N = 3) and a tic disorder (Tourette's Disorder N = 20; chronic motor tic disorder N = 5). At an average dose of 2.0 +/- 0.6 mg/ day, guanfacine was associated with mean improvement of 27% on the Hyperactivity Index (N = 25; t = 4.61; p < 0.001), 32% on the total score of the teacher-rated ADHD Scale (N = 19; t = 5.27; p < 0.001), and 39% on the total tic severity scale (N = 19; t = 4.17; p < 0.001). Mild and statistically insignificant decreases in blood pressure and pulse were observed in the sample as a whole. Five subjects had endpoint systolic blood pressure below 1 SD from their age and gender norms. CONCLUSION: Results of this open-label study add to the growing data base on the safety and efficacy of guanfacine in children with ADHD and tic disorders.

Adolescent↗