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Biomedical subjects

J S March

Publications and source records attributed to J S March.

At least 37 records · Page 2Linked to original sources

Absence of cardiovascular adverse effects of sertraline in children and adolescents.

OBJECTIVE: In a 12 week, placebo-controlled, parallel-design, multicenter study of sertraline for obsessive-compulsive disorder in 107 children and 80 adolescents, the authors prospectively assessed cardiovascular effects to doses of sertraline of < or = 200 mg/day. METHOD: Vital signs (blood pressure and heart rate) and electrocardiograph parameters (ECGs) were systematically evaluated at baseline and again throughout treatment. RESULTS: There were no clinically significant cardiovascular adverse events in any of the subjects enrolled in the study. Moreover, compared with baseline and placebo, sertraline treatment at an average dose of 167 mg did not result in any clinically meaningful changes in any ECG indices (PR, QRS, and QTc intervals), cardiac rhythm, blood pressure, or heart rate. CONCLUSIONS: These prospectively derived results support the cardiovascular safety of sertraline at doses up to 200 mg in children and adolescents.

Adolescent↗

Sertraline in children and adolescents with obsessive-compulsive disorder: a multicenter randomized controlled trial.

CONTEXT: The serotonin reuptake inhibitors are the treatment of choice for patients with obsessive-compulsive disorder; however, empirical support for this assertion has been weaker for children and adolescents than for adults. OBJECTIVE: To evaluate the safety and efficacy of the selective serotonin reuptake inhibitor sertraline hydrochloride in children and adolescents with obsessive-compulsive disorder. DESIGN: Randomized, double-blind, placebo-controlled trial. PATIENTS: One hundred eighty-seven patients: 107 children aged 6 to 12 years and 80 adolescents aged 13 to 17 years randomized to receive either sertraline (53 children, 39 adolescents) or placebo (54 children, 41 adolescents). SETTING: Twelve US academic and community clinics with experience conducting randomized controlled trials. INTERVENTION: Sertraline hydrochloride was titrated to a maximum of 200 mg/d during the first 4 weeks of double-blind therapy, after which patients continued to receive this dosage of medication for 8 more weeks. Control patients received placebo. MAIN OUTCOME MEASURES: The Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), the National Institute of Mental Health Global Obsessive Compulsive Scale (NIMH GOCS), and the NIMH Clinical Global Impressions of Severity of Illness (CGI-S) and Improvement (CGI-I) rating scales. RESULTS: In intent-to-treat analyses, patients treated with sertraline showed significantly greater improvement than did placebo-treated patients on the CY-BOCS (adjusted mean, -6.8vs -3.4, respectively; P=.005), the NIMH GOCS (-2.2 vs -1.3, respectively; P=.02), and the CGI-I (2.7 vs 3.3, respectively; P=.002) scales. Significant differences in efficacy between sertraline and placebo emerged at week 3 and persisted for the duration of the study. Based on CGI-I ratings at end point, 42% of patients receiving sertraline and 26% of patients receiving placebo were very much or much improved. Neither age nor sex predicted response to treatment. The incidence of insomnia, nausea, agitation, and tremor were significantly greater in patients receiving sertraline; 12 (13%) of 92 sertraline-treated patients and 3 (3.2%) of 95 placebo-treated patients discontinued prematurely because of adverse medical events (P=.02). No clinically meaningful abnormalities were apparent on vital sign determinations, laboratory findings, or electrocardiographic measurements. CONCLUSION: Sertraline appears to be a safe and effective short-term treatment for children and adolescents with obsessive-compulsive disorder.

Adolescent↗

Racial differences on the Conners Teacher Rating Scale.

Factor congruence and mean differences on the Conners Teacher Rating Scale were assessed across African-American and Caucasian school children. Factor analyses conducted separately by gender revealed similar factors across races for males and females. The main differences in factor structure within gender were the presence of an Antisocial factor in black males and an Inattention factor in white females. Across both males and females, teachers tended to rate black children higher than white children on factors relating to externalizing behaviors. Whether mean differences are a result of teacher bias or actual behavioral differences in the classroom needs further research.

Adolescent↗

Predicting the outcome of treatment.

The clinical question--"Which treatment(s) for which patients with what set of subgrouping characteristics working by what mechanism(s)?"--rests at the heart of differential therapeutics. Experimentally, this question reduces to a test of how well we can predict the outcome of treatment using the treatment conditions plus other moderating and mediating variables. Reflecting the discussions held at a recent National Institute of Mental Health (NIMH) conference on psychosocial treatments, and using pediatric anxiety disorders as a case in point, we discuss the problem of prediction in treatment outcome studies from the standpoint of definition of terms, using the general linear model of prediction. We also outline types of studies that may be useful in testing potential predictors, and put forward a possible matrix of predictor variables as currently implemented in an NIMH-funded treatment outcome study of pediatric obsessive-compulsive disorder (OCD). We conclude by making specific suggestions for implementing a broader approach to the study of predictors.

Adolescent↗

Cognitive-behavioral psychotherapy for children and adolescents with posttraumatic stress disorder after a single-incident stressor.

OBJECTIVE: To test the efficacy of a group-administered cognitive-behavioral psychotherapy (CBT) protocol for pediatric posttraumatic stress disorder (PTSD) after a single-incident stressor. METHOD: After a school-wide selection-to-treatment procedure conducted in two elementary and two junior high schools, children and adolescents with DSM-IV PTSD by structured interview were entered into an 18-week, group-administered CBT protocol using a single case across time and setting experimental design. Assessments of PTSD, anxiety, depression, trait anger, locus of control, and disruptive behavior were conducted at baseline, posttreatment, and at 6-month follow-up. RESULTS: Experimental control across time (staggered start date) and setting (school and age) was demonstrated. Fourteen of 17 subjects completed treatment. Of these, 8 (57%) no longer met DSM-IV criteria for PTSD immediately after treatment; 12 (86%) of 14 were free of PTSD at 6-month follow-up. On intent-to-treat analyses, treatment produced a robust beneficial effect posttreatment on the Clinician-Administered PTSD Scale-Child and Adolescent Version, with additional improvement accruing at follow-up (p < .001). Improvements of a similar magnitude were seen for depression (p < .001), anxiety (p < .001), and anger (p < .005). Locus of control remained external from pre- to posttreatment but became strongly internal at follow-up (p < .001). CONCLUSION: More clinical trials are required to confirm that CBT is a safe, acceptable, and effective treatment for PTSD in children and adolescents.

Adolescent↗

National Institute of Mental Health Collaborative Multimodal Treatment Study of Children with ADHD (the MTA). Design challenges and choices.

The Collaborative Multimodal Treatment Study of Children with Attention Deficit Hyperactivity Disorder (ADHD), the MTA, is the first child multisite cooperative agreement treatment study of children conducted by the National Institute of Mental Health, Rockville, Md. It examines the long-term effectiveness of medication vs behavioral treatment vs both for treatment of ADHD and compares state-of-the-art treatment with routine community care. In a parallel-groups design, 576 children (age, 7-9 years) with ADHD (96 at each site) are thoroughly assessed and randomized to 4 conditions: (1) medication alone, (2) psychosocial treatment alone, (3) the combination of both, (4) or community comparison. The first 3 groups are treated for 14 months and all are reassessed periodically for 24 months. Designers met the following challenges: framing clinically relevant primary questions; defining the target population; choice, intensity, and integration and combination of treatments for fair comparisons; combining scientific controls and standardization with clinical flexibility; and implementing a controlled clinical trial in a nonclinical setting (school) controlled by others. Innovative solutions included extensive decision algorithms and manualized adaptations of treatments to specific needs.

Attention Deficit Disorder with Hyperactivity↗

The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity.

OBJECTIVE: To describe the history, factor structure, reliability, and validity of the Multidimensional Anxiety Scale for Children (MASC). METHOD: In two separate school-based population studies, principal-components factor analysis was used, first, to test a theory-driven factor structure, and second, to develop an empirically derived factor structure for the MASC. In a separate study using a clinical population, test-retest reliability at 3 weeks and 3 months, interrater concordance, and convergent and divergent validity were examined. RESULTS: The final version of the MASC consists of 39 items distributed across four major factors, three of which can be parsed into two subfactors each. Main and subfactors include (1) physical symptoms (tense/restless and somatic/autonomic), (2) social anxiety (humiliation/rejection and public performance fears), (3) harm avoidance (perfectionism and anxious coping), and (4) separation anxiety. The MASC factor structure, which presumably reflects the in the vivo structure of pediatric anxiety symptoms, is invariant across gender and age and shows excellent internal reliability. As expected, females show greater anxiety on all factors and subfactors than males. Three-week and 3-month test-retest reliability was satisfactory to excellent. Parent-child agreement was poor to fair. Concordance was greatest for easily observable symptom clusters and for mother-child over father-child or father-mother pairs. Shared variance with scales sampling symptom domains of interest was highest for anxiety, intermediate for depression, and lowest for externalizing symptoms, indicating adequate convergent and divergent validity. CONCLUSION: The MASC is a promising self-report scale for assessing anxiety in children and adolescents.

Adolescent↗

Posttraumatic symptomatology in children and adolescents after an industrial fire.

OBJECTIVE: This investigation evaluated the extent and nature of posttraumatic symptomatology (PTS) in children and adolescents 9 months after an industrial fire at the imperial Foods chicken-processing plant in Hamlet, North Carolina, caused extensive loss of life. METHOD: Using a PTS self-report measure plus self- and teacher reports of comorbid symptoms the authors surveyed 1,019 fourth- to ninth-grade students in the community where the fire occurred. RESULTS: Three factors comprising PTS were identified: reexperiencing, avoidance and hyperarousal. Reexperiencing and avoidance were positively correlated; hyperarousal proved weakly correlated with reexperiencing, perhaps because exposure was largely indirect. Using a T score cutoff of 65 on the reexperiencing factor as indicative of PTS 9.7% of subjects met criteria for PTS; 11.9% met criteria for posttraumatic stress disorder (PTSD) using DSM-III-R PTSD criteria. Degree of exposure was the most powerful predictor of PTS. Race (African-American) and gender (female) posed significant risk factors for PTS. Self-reported internalizing symptoms and teacher-reported externalizing symptoms were positively predicted by intercurrent PTS, and independently of PTS, by degree of exposure. Comorbid symptoms showed interesting interactions with exposure, race, and gender. Lack of self-attributed personal efficacy predicted PTS but did not moderate the effects of race or gender on PTS risk. CONCLUSIONS: This study, which used a population-based sampling strategy, strengthens and extends findings from earlier literature on pediatric PTSD in showing that (1) PTS and comorbid internalizing and externalizing symptoms rise in direct proportion to degree of exposure; (2) gender and race show variable effects on risk for PTS and comorbid symptoms; and (3) comorbid symptoms are positively correlated with PTS and may represent primary outcomes of traumatic exposure in their own right.

Adolescent↗

Obsessive-compulsive disorder in children and adolescents: a review of the past 10 years.

OBJECTIVE: To review the literature on pediatric obsessive-compulsive disorder (OCD) from the perspective of information relevant to American Board of Psychiatry and Neurology recertification in child and adolescent psychiatry. METHOD: The clinical and research literatures were systematically searched or articles that address the diagnosis and treatment of pediatric OCD. RESULTS: Drawing from the literature and their own clinical experience, the authors note that (1) OCD is a common neuropsychiatric disorder; (2) comorbidity is common, especially with tic, attention-deficit, anxiety, and affective disorders; (3) OCD following group A beta-hemolytic streptococcal infection may define an autoimmune sub-grouping calling for immunomodulatory treatments; and (4) OCD-specific cognitive-behavioral psychotherapy and pharmacotherapy with a serotonin reuptake inhibitor define the psychotherapeutic and pharmacotherapeutic treatments of choice, respectively. CONCLUSION: Child psychiatrists should be familiar with the differential diagnosis and treatment of OCD.

Adolescent↗

Medication treatment strategies in the MTA Study: relevance to clinicians and researchers.

OBJECTIVE: Clinicians have difficulty applying drug research findings to clinical practice, because research protocols use methods different from those used in daily office practice settings. METHOD: To design a medication protocol for a multisite clinical trial involving 576 children with attention-deficit hyperactivity disorder (ADHD) while maintaining relevance to clinical practice, investigators from the NIMH Collaborative Multisite Multimodal Treatment Study of Children with Attention-Deficit/Hyperactivity Disorder (MTA study) developed novel medication strategies. These were designed to work either in a monomodal or multimodal format and to ensure standard approaches are used across diverse sites. Each child randomized to medication (projected N = 288) is individually titrated to his or her "best" methylphenidate dose and has individual ADHD symptoms monitored. Decision rules were developed to guide "best dose" selection, dose changes, medication changes, the management of side effects, and integration with psychosocial treatments. CONCLUSIONS: The MTA study uses a controlled method to standardize the identification of each child's "best" methylphenidate dose in a national, multisite cooperative treatment program. Although the titration protocol is complex, the study's individual dosing approach and algorithms for openly managing ADHD children's medication over time will be of interest to clinicians in office practice.

Adolescent↗

Cognitive-behavioral psychotherapy for children and adolescents with OCD: a review and recommendations for treatment.

OBJECTIVE: To critically review the published literature on cognitive-behavioral psychotherapy for obsessive-compulsive disorder (OCD) in children and adolescents. METHOD: The psychiatric and psychological literature was systematically searched for "studies" applying cognitive-behavioral principles to children and adolescents with OCD. RESULTS: Thirty-two investigations, most of them single case reports, were identified. Despite manifold differences in terminology and theoretical framework, all but one showed some benefit for cognitive-behavioral interventions. Graded exposure and response prevention form the core of treatment; anxiety management training and OCD-specific family interventions may play an adjunctive role. Poor compliance, inadequately documented and inconsistently applied treatment, and lack of exportability were recurrent problems. CONCLUSIONS: Abundant clinical and emerging empirical evidence suggest that cognitive-behavioral psychotherapy, alone or in combination with pharmacotherapy, is an effective treatment for OCD in children and adolescents. Future research in this area will need to focus on comparisons of cognitive-behavioral psychotherapy to other treatments, on component analyses, and on the application of exportable protocol-driven treatments to divergent patient populations.

Adolescent↗

Neuropsychiatry of obsessive-compulsive disorder in children and adolescents.

Physicians understanding of the pathobiobiology, diagnosis, and treatment of OCD in children and adolescents closely resembles that for OCD in adults. Moreover, it is now clear that OCD is a neurobehavioral disorder involving dysregulation in links between cortical and subcortical circuitry that is substantially influenced by serotonergic neurotransmission. Although current treatments are not generally curative, given a correct diagnosis and the skillful combination of pharmacotherapy with a serotonin reuptake inhibitor and focused cognitive-behavioral psychotherapy, most children can be helped to resume a normal developmental trajectory.

Adolescent↗

A double-blind, placebo-controlled trial of fluvoxamine versus imipramine in outpatients with major depression.

The authors employed a double-blind, placebo-controlled design to investigate the effectiveness of fluvoxamine versus imipramine in 54 outpatients with moderate major depression. Fluvoxamine proved superior to placebo but not to imipramine on the Hamilton Rating Scale for Depression and the Montgomery and Asberg Depression Rating Scale. Nausea and hyperarousal were the most common side effects in the fluvoxamine-treated patients.

Adolescent↗

Clomipramine and obsessive compulsive disorder: a placebo-controlled double-blind study of 32 patients.

Thirty-two nondepressed patients with obsessive compulsive disorder were randomly assigned to treatment with clomipramine (N = 16) or placebo (N = 16) in a 10-week double-blind study. Of the 15 patients who received at least 3 weeks of clomipramine treatment, 11 (73%) improved, 5 (33%) improved by more than 50%, and none worsened. Only 2 (12.5%) of the 16 placebo-treated patients improved, 1 (6%) by more than 50%; two (13%) worsened. Clomipramine treatment was associated with statistically significant improvement on several measures of obsessive compulsive symptoms. Side effects were more frequent and severe with clomipramine than with placebo. Although most patients tolerated clomipramine well, 3 discontinued treatment because of side effects.

Adult↗