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Full-Text Articles in Medicine and Health Sciences
Safety And Efficacy Of Abt-089 In Pediatric Attention-Deficit/Hyperactivity Disorder: Results From Two Randomized Placebo-Controlled Clinical Trials., Timothy E. Wilens, Laura M. Gault, Ann Childress, Christopher J. Kratochvil, Lindsey Bensman, Coleen M. Hall, Evelyn Olson, Weining Z. Robieson, Tushar S. Garimella, Walid M. Abi-Saab, George Apostol, Mario D. Saltarelli
Safety And Efficacy Of Abt-089 In Pediatric Attention-Deficit/Hyperactivity Disorder: Results From Two Randomized Placebo-Controlled Clinical Trials., Timothy E. Wilens, Laura M. Gault, Ann Childress, Christopher J. Kratochvil, Lindsey Bensman, Coleen M. Hall, Evelyn Olson, Weining Z. Robieson, Tushar S. Garimella, Walid M. Abi-Saab, George Apostol, Mario D. Saltarelli
Journal Articles: Psychiatry
OBJECTIVE: To assess the safety and efficacy of ABT-089, a novel α(4)β(2) neuronal nicotinic receptor partial agonist, vs. placebo in children with attention-deficit/hyperactivity disorder (ADHD).
METHOD: Two multicenter, randomized, double-blind, placebo-controlled, parallel-group studies of children 6 through 12 years of age were conducted. Study 1 (n = 274) assessed six treatment groups over 8 weeks: 4 once-daily (QD) ABT-089 doses (0.085-0.700 mg/kg), QD atomoxetine, and placebo. Study 2 (n = 119) assessed three treatment groups over 6 weeks: 2 QD ABT-089 doses (0.7 mg/kg, 1.4 mg/kg) and placebo. The primary efficacy variable was the investigator-administered Attention-Deficit/Hyperactivity Disorder Rating Scale-IV: Home …
An Exploratory Analysis Of The Impact Of Family Functioning On Treatment For Depression In Adolescents., Norah C. Feeny, Susan G. Silva, Mark A. Reinecke, Steven Mcnulty, Robert L. Findling, Paul Rohde, John F. Curry, Golda S. Ginsburg, Christopher J. Kratochvil, Sanjeev M. Pathak, Diane E. May, Betsy D. Kennard, Anne D. Simons, Karen C. Wells, Michele Robins, David Rosenberg, John S. March
An Exploratory Analysis Of The Impact Of Family Functioning On Treatment For Depression In Adolescents., Norah C. Feeny, Susan G. Silva, Mark A. Reinecke, Steven Mcnulty, Robert L. Findling, Paul Rohde, John F. Curry, Golda S. Ginsburg, Christopher J. Kratochvil, Sanjeev M. Pathak, Diane E. May, Betsy D. Kennard, Anne D. Simons, Karen C. Wells, Michele Robins, David Rosenberg, John S. March
Journal Articles: Psychiatry
This article explores aspects of family environment and parent-child conflict that may predict or moderate response to acute treatments among depressed adolescents (N = 439) randomly assigned to fluoxetine, cognitive behavioral therapy, their combination, or placebo. Outcomes were Week 12 scores on measures of depression and global impairment. Of 20 candidate variables, one predictor emerged: Across treatments, adolescents with mothers who reported less parent-child conflict were more likely to benefit than their counterparts. When family functioning moderated outcome, adolescents who endorsed more negative environments were more likely to benefit from fluoxetine. Similarly, when moderating effects were seen on cognitive behavioral …
Dysfunctional Attitudes Scale Perfectionism: A Predictor And Partial Mediator Of Acute Treatment Outcome Among Clinically Depressed Adolescents., Rachel H. Jacobs, Susan G. Silva, Mark A. Reinecke, John F. Curry, Golda S. Ginsburg, Christopher J. Kratochvil, John S. March
Dysfunctional Attitudes Scale Perfectionism: A Predictor And Partial Mediator Of Acute Treatment Outcome Among Clinically Depressed Adolescents., Rachel H. Jacobs, Susan G. Silva, Mark A. Reinecke, John F. Curry, Golda S. Ginsburg, Christopher J. Kratochvil, John S. March
Journal Articles: Psychiatry
The effect of perfectionism on acute treatment outcomes was explored in a randomized controlled trial of 439 clinically depressed adolescents (12-17 years of age) enrolled in the Treatment for Adolescents with Depression Study (TADS) who received cognitive behavior therapy (CBT), fluoxetine, a combination of CBT and FLX, or pill placebo. Measures included the Children's Depression Rating Scale-Revised, the Suicidal Ideation Questionnaire-Grades 7-9, and the perfectionism subscale from the Dysfunctional Attitudes Scale (DAS). Predictor results indicate that adolescents with higher versus lower DAS perfectionism scores at baseline, regardless of treatment, continued to demonstrate elevated depression scores across the acute treatment period. …
Treatment Response In Depressed Adolescents With And Without Co-Morbid Attention-Deficit/Hyperactivity Disorder In The Treatment For Adolescents With Depression Study., Christopher J. Kratochvil, Diane E. May, Susan G. Silva, Vishal Madaan, Susan E. Puumala, John F. Curry, John Walkup, Hayden Kepley, Benedetto Vitiello, John S. March
Treatment Response In Depressed Adolescents With And Without Co-Morbid Attention-Deficit/Hyperactivity Disorder In The Treatment For Adolescents With Depression Study., Christopher J. Kratochvil, Diane E. May, Susan G. Silva, Vishal Madaan, Susan E. Puumala, John F. Curry, John Walkup, Hayden Kepley, Benedetto Vitiello, John S. March
Journal Articles: Psychiatry
OBJECTIVE: In the Treatment for Adolescents with Depression Study (TADS), fluoxetine (FLX) and the combination of fluoxetine with cognitive-behavioral therapy (COMB) had superior improvement trajectories compared to pill placebo (PBO), whereas cognitive-behavioral therapy (CBT) was not significantly different from PBO. Because attention-deficit/hyperactivity disorder (ADHD) and major depressive disorder (MDD) frequently co-exist, we examined whether ADHD moderated these outcomes in TADS.
METHOD: A total of 439 adolescents with MDD, 12-17 years old, were randomized to FLX, CBT, COMB, or PBO. Random coefficients regression models examined depression improvement in 377 depressed youths without ADHD and 62 with ADHD, including 20 who were …
Antidepressant Prescribing Practices For The Treatment Of Children And Adolescents., Supriya K. Bhatia, Amy J. Rezac-Elgohary, Benedetto Vitiello, Michael A. Sitorius, Bruce A. Buehler, Christopher J. Kratochvil
Antidepressant Prescribing Practices For The Treatment Of Children And Adolescents., Supriya K. Bhatia, Amy J. Rezac-Elgohary, Benedetto Vitiello, Michael A. Sitorius, Bruce A. Buehler, Christopher J. Kratochvil
Journal Articles: Psychiatry
OBJECTIVE: This study evaluates pediatric antidepressant prescribing practices of Nebraska clinicians.
METHODS: Surveys were sent in July, 2005, to 1,521 prescribing clinicians throughout Nebraska to assess pediatric antidepressant use along with any practice changes following the U.S. Food and Drug Administration (FDA) "black box" warning issued in October, 2004.
RESULTS: Over half (n = 866) of the clinicians responded to the survey, of which 96.8% reported awareness of the FDA "black box" warning. Of the respondents, 76.9% (n = 666) were prescribing antidepressants to children and/or adolescents. Clinicians reported decreased prescribing frequency for both children (15.5%) and adolescents (36.6%), with …
Effects Of Atomoxetine On Growth In Children With Attention-Deficit/Hyperactivity Disorder Following Up To Five Years Of Treatment., Thomas J. Spencer, Christopher J. Kratochvil, R. Bart Sangal, Keith E. Saylor, Charles E. Bailey, David W. Dunn, Daniel A. Geller, Charles D. Casat, Robert S. Lipetz, Rakesh Jain, Jeffrey H. Newcorn, Dustin D. Ruff, Peter D. Feldman, Amanda J. Furr, Albert J. Allen
Effects Of Atomoxetine On Growth In Children With Attention-Deficit/Hyperactivity Disorder Following Up To Five Years Of Treatment., Thomas J. Spencer, Christopher J. Kratochvil, R. Bart Sangal, Keith E. Saylor, Charles E. Bailey, David W. Dunn, Daniel A. Geller, Charles D. Casat, Robert S. Lipetz, Rakesh Jain, Jeffrey H. Newcorn, Dustin D. Ruff, Peter D. Feldman, Amanda J. Furr, Albert J. Allen
Journal Articles: Psychiatry
OBJECTIVE: To examine the effects on growth of long-term pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD), we present findings from an ongoing 5-year study of the efficacy and safety of treatment with atomoxetine.
METHODS: North American patients, 6-17 years old at study entry (N = 1,312) and with Diagnostic and Statistical Manual of Mental Disorders,4th edition (DSM-IV) ADHD, were studied under open-label atomoxetine treatment. Sixty-one were studied up to 5 years.
RESULTS: After 1 month's treatment, patients weighed less than expected from their starting percentiles relative to population norms, with a maximum shortfall at 15 months and a return to expected …
A Pilot Study Of Atomoxetine In Young Children With Attention-Deficit/Hyperactivity Disorder., Christopher J. Kratochvil, Brigette S. Vaughan, Michelle L. Mayfield-Jorgensen, John S. March, Scott H. Kollins, Desiree W. Murray, Hima Ravi, Laurence L. Greenhill, Lisa A. Kotler, Natalya Paykina, Patricia Biggins, Julie Stoner
A Pilot Study Of Atomoxetine In Young Children With Attention-Deficit/Hyperactivity Disorder., Christopher J. Kratochvil, Brigette S. Vaughan, Michelle L. Mayfield-Jorgensen, John S. March, Scott H. Kollins, Desiree W. Murray, Hima Ravi, Laurence L. Greenhill, Lisa A. Kotler, Natalya Paykina, Patricia Biggins, Julie Stoner
Journal Articles: Psychiatry
OBJECTIVE: The purpose of this study was to assess the effectiveness and tolerability of atomoxetine during acute treatment of attention-deficit/hyperactivity disorder (ADHD) in 5 and 6 year olds.
METHOD: Twenty two children (male n = 19, 86%) with ADHD were treated with atomoxetine for 8 weeks in a three-site, open-label pilot study. Dosing was flexible, with titration to a maximum of 1.8 mg/kg per day. Parent education on behavior management was provided as part of each pharmacotherapy visit.
RESULTS: Subjects demonstrated a mean decrease of 20.68 points (SD = 12.80, p < 0.001)) on the ADHD Rating Scale-IV (ADHD-IV-RS) total score, 10.18 (SD = 7.48, p < 0.001) on the inattentive subscale and 10.50 (SD = 7.04, p < 0.001) on the hyperactive/impulsive subscale. Clinical Global Impression-Severity (CGI-S) was improved in 82% of the children (95% CI, 66-98%) and Children's Global Assessment (CGAS) scores improved 18.91 points on average (SD = 12.20, p < 0.001). The mean final dose of atomoxetine was 1.25 mg/kg per day (SD = 0.35 mg/kg per day). Mood lability was the most commonly reported adverse event (n = 12, 54.5%). Eleven subjects (50%) reported decreased appetite and a mean weight loss of 1.04 kg (SD = 0.80 kg) (p < 0.001) was observed for the group. Vital sign changes were mild and not clinically significant. There were no discontinuations due to adverse events or lack of efficacy.
CONCLUSION: Atomoxetine was generally effective for reducing core ADHD …
Emotional Expression During Attention-Deficit/Hyperactivity Disorders Treatment: Initial Assessment Of Treatment Effects., Christopher J. Kratochvil, D. Faries, Brigette S. Vaughan, A. Perwien, J. Busner, K. Saylor, S. Kaplan, C. Buermeyer, R. Swindle
Emotional Expression During Attention-Deficit/Hyperactivity Disorders Treatment: Initial Assessment Of Treatment Effects., Christopher J. Kratochvil, D. Faries, Brigette S. Vaughan, A. Perwien, J. Busner, K. Saylor, S. Kaplan, C. Buermeyer, R. Swindle
Journal Articles: Psychiatry
OBJECTIVE: The purpose of this research was to provide an initial examination of the effects of atomoxetine and stimulants on emotional expression using a newly developed scale for assessing emotional expression in children with attention-deficit/hyperactivity disorder (ADHD).
METHOD: The parent-rated Expression and Emotion Scale for Children (EESC) was collected during two studies. During a cross-sectional validation study, the EESC was completed to assess the child's current treatment and retrospectively for previous medication. In a randomized, placebo-controlled trial of atomoxetine, the EESC was collected at baseline and endpoint.
RESULTS: In the validation study, no statistically significant differences in EESC scores were …
Atomoxetine Treatment In Children And Adolescents With Attention-Deficit Hyperactivity Disorder: What Are The Long-Term Health-Related Quality-Of-Life Outcomes?, Amy R. Perwien, Christopher J. Kratochvil, Douglas E. Faries, Brigette S. Vaughan, Thomas Spencer, Ronald T. Brown
Atomoxetine Treatment In Children And Adolescents With Attention-Deficit Hyperactivity Disorder: What Are The Long-Term Health-Related Quality-Of-Life Outcomes?, Amy R. Perwien, Christopher J. Kratochvil, Douglas E. Faries, Brigette S. Vaughan, Thomas Spencer, Ronald T. Brown
Journal Articles: Psychiatry
OBJECTIVE: Numerous investigations have examined the efficacy of pharmacological treatment for attention-deficit/hyperactivity disorder (ADHD) in children. However, relatively few studies have addressed the impact of treatment on long-term subjective, psychosocial outcomes, such as health-related quality of life (HRQL). This study examines the long-term effects of pharmacological treatment with atomoxetine on HRQL in children and adolescents with ADHD.
METHODS: Participants included 6- to 17-year-old children and adolescents (n = 912) with ADHD enrolled in a 24-month, multicenter, open-label trial of atomoxetine. Outcomes included clinician ratings of ADHD, parent ratings of ADHD, and a widely used measure of HRQL (The Child Health …
Treatment For Adolescents With Depression Study (Tads): Safety Results., Graham Emslie, Christopher J. Kratochvil, Benedetto Vitiello, Susan Silva, Taryn Mayes, Steven Mcnulty, Elizabeth Weller, Bruce Waslick, Charles Casat, John Walkup, Sanjeev Pathak, Paul Rohde, Kelly Posner, John March, The Columbia Suicidality Classification Group, Tads Team
Treatment For Adolescents With Depression Study (Tads): Safety Results., Graham Emslie, Christopher J. Kratochvil, Benedetto Vitiello, Susan Silva, Taryn Mayes, Steven Mcnulty, Elizabeth Weller, Bruce Waslick, Charles Casat, John Walkup, Sanjeev Pathak, Paul Rohde, Kelly Posner, John March, The Columbia Suicidality Classification Group, Tads Team
Journal Articles: Psychiatry
OBJECTIVE: To compare the rates of physical, psychiatric, and suicide-related events in adolescents with MDD treated with fluoxetine alone (FLX), cognitive-behavioral therapy (CBT), combination treatment (COMB), or placebo (PBO).
METHOD: Safety assessments included adverse events (AEs) collected by spontaneous report, as well as systematic measures for specific physical and psychiatric symptoms. Suicidal ideation and suicidal behavior were systematically assessed by self- and clinician reports. Suicidal events were also reanalyzed by the Columbia Group and expert raters using the Columbia-Classification Algorithm for Suicidal Assessment used in the U.S. Food and Drug Administration reclassification effort.
RESULTS: Depressed adolescents reported high rates of …
Selective Serotonin Reuptake Inhibitors In Pediatric Depression: Is The Balance Between Benefits And Risks Favorable?, Christopher J. Kratochvil, Benedetto Vitiello, John Walkup, Graham Emslie, Bruce D. Waslick, Elizabeth B. Weller, William J. Burke, John S. March
Selective Serotonin Reuptake Inhibitors In Pediatric Depression: Is The Balance Between Benefits And Risks Favorable?, Christopher J. Kratochvil, Benedetto Vitiello, John Walkup, Graham Emslie, Bruce D. Waslick, Elizabeth B. Weller, William J. Burke, John S. March
Journal Articles: Psychiatry
Recent controversies surrounding the use of selective serotonin reuptake inhibitors (SSRIs) have highlighted the need to reassess potential benefits, as well as potential risks of this class of medications in the treatment of pediatric depression. The recent availability of data from meta-analyses of published and unpublished antidepressant trials, epidemiological studies, and the Treatment for Adolescents with Depression Study (TADS) has facilitated a reanalysis of this risk/benefit relationship. Despite reviewing similar data, various regulatory agencies have arrived at rather disparate conclusions regarding the data, resulting in continued controversy. Although all groups appear to agree that careful assessment, education regarding risks, and …
An Open-Label Trial Of Tomoxetine In Pediatric Attention Deficit Hyperactivity Disorder., Christopher J. Kratochvil, Daryl Bohac, Martin Harrington, Natalie Baker, Diane E. May, William J. Burke
An Open-Label Trial Of Tomoxetine In Pediatric Attention Deficit Hyperactivity Disorder., Christopher J. Kratochvil, Daryl Bohac, Martin Harrington, Natalie Baker, Diane E. May, William J. Burke
Journal Articles: Psychiatry
OBJECTIVE: To collect pilot data assessing the safety, tolerability, and efficacy of tomoxetine, a nonstimulant norepinephrine enhancer, in pediatric attention deficit hyperactivity disorder (ADHD).
METHODS: An open-label trial of tomoxetine in pediatric ADHD was conducted as part of a multisite clinical trial. Following a baseline assessment, an ascending dose titration was completed during 10 weekly visits.
RESULTS: Ten subjects were enrolled at baseline, with eight completing the study. Seven of the eight remaining subjects met efficacy criteria. Significant decreases in symptom severity ratings by parents and study investigators were found. The medication was well tolerated, with transient appetite suppression the …