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Joseph Biederman - One of the best experts on this subject based on the ideXlab platform.

  • a post hoc subgroup analysis of an 18 day randomized controlled trial comparing the tolerability and efficacy of mixed amphetamine salts extended release and Atomoxetine in school age girls with attention deficit hyperactivity disorder
    Clinical Therapeutics, 2006
    Co-Authors: Joseph Biederman, Thomas J Spencer, Sharon B Wigal, James J Mcgough, David A Mays
    Abstract:

    Abstract Background: Because the scientific literature on the pharmacotherapy of attention-deficit/hyperactivity disorder (ADHD) is almost entirely based on the results of studies in samples consisting primarily of boys, much is unknown about the treatment response in girls. Objective: This post hoc analysis compared the efficacy, tolerability, and time course of the effect of mixed amphetamine salts extended release (MAS XR) and Atomoxetine in school-age girls with ADHD. Methods: This was an intent-to-treat subanalysis of the data from girls enrolled in a multicenter, 18-day, randomized, double-blind, parallel-group, forced dosetitration, laboratory school study enrolling boys and girls aged 6 to 12 years with ADHD. The study compared the efficacy, tolerability, and time course of the effect of increasing doses of MAS XR (10, 20, and 30 mg/d) and Atomoxetine (0.5 and 1.2 mg/kg per day). The laboratory school sessions were organized in cycles to include 12 hours of observation. Efficacy measures included the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) deportment rating subscale, the SKAMP attention rating subscale, and academic testing (number of math problems attempted and answered correctly). Adverse events were assessed throughout the study period. Tolerability and efficacy measures were assessed during laboratory school visits on days 7, 14, and 21. Results: This subanalysis included 57 girls (median age, 9 years; 49.1% white, 22.8% black, 17.5% Hispanic) with a diagnosis of ADHD, combined subtype. Twenty-six girls were randomized to receive MAS XR and 31 were randomized to receive Atomoxetine. Mean SKAMP deportment and attention subscale scores in the 2 groups were similar at baseline. Mean changes from baseline were significantly greater for MAS XR compared with Atomoxetine on the SKAMP deportment score (−0.48 vs −0.04, respectively; P P P P P =0.04). Both MAS XR and Atomoxetine were well tolerated. The most frequently occurring treatment-related adverse events in girls receiving MAS XR were decreased appetite (40.7%), upper abdominal pain (29.6%), insomnia (25.9%), and headache (14.8%). The most frequently occurring treatment-related adverse events in girls receiving Atomoxetine were somnolence (28.1%), upper abdominal pain (15.6%), vomiting (15.6%), nausea (12.5%), and decreased appetite (12.5%). Conclusion: This post hoc analysis in a subpopulation of girls with ADHD, combined subtype, found that 18-day treatment with MAS XR was significantly more effective than Atomoxetine in terms of ratings of classroom behavior, attention, and academic productivity.

  • Atomoxetine and stroop task performance in adult attention deficit hyperactivity disorder
    Journal of Child and Adolescent Psychopharmacology, 2005
    Co-Authors: Stephen V Faraone, Thomas J Spencer, Joseph Biederman, David Michelson, Lenard A Adler, Frederick W Reimherr, Larry J Seidman
    Abstract:

    Objective: The aim of this study was to assess the efficacy of Atomoxetine, a new and highly selective inhibitor of the norepinephrine transporter, for executive functioning in adults with attention-deficit/hyperactivity disorder (ADHD). Method: Two identical studies using a double-blind, placebo-controlled, parallel design were conducted. Patients were adults (Study 1, n = 280; Study 2, n = 256) with Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)-defined ADHD recruited by referral and advertising. They were randomized to 10 weeks of treatment with Atomoxetine or placebo. Executive functions were measured by the Stroop task. Results: There was no evidence of cognitive deterioration associated with Atomoxetine treatment. Atomoxetine treatment was associated with an improvement of the Stroop colorword score. Conclusions: Our results provide further support for Spencer et al.'s (1998) report that Atomoxetine improves inhibitory capacity, as measured by the Stroop task. The absenc...

  • A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and Atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder.
    Journal of Attention Disorders, 2005
    Co-Authors: Sharon B Wigal, Thomas J Spencer, Joseph Biederman, James T Mccracken, James J Mcgough, Kelly Posner, Timothy Wigal, Scott H. Kollins, Tanya M. Clark, David A Mays
    Abstract:

    Mixed amphetamine salts extended release (MAS XR; Adderall XR®) and Atomoxetine (Strattera®) were compared in children 6 to 12 years old with attention deficit/hyperactivity disorder (ADHD) combined or hyperactive/impulsive type in a randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study. Primary efficacy measure was the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) behavioral rating scale. Changes in mean SKAMP deportment scores from baseline were significantly greater for MAS XR (n = 102) than for Atomoxetine (n = 101) overall (-0.56 and -0.13, respectively; p < .0001) and at each week (p < .001). Adverse events were similar for both treatment groups. The extended time course of action and greater therapeutic efficacy of MAS XR suggests that it is more effective than Atomoxetine in children with ADHD.

  • relapse prevention in pediatric patients with adhd treated with Atomoxetine a randomized double blind placebo controlled study
    Journal of the American Academy of Child and Adolescent Psychiatry, 2004
    Co-Authors: David Michelson, Marina Danckaerts, Thomas J Spencer, Douglas E Faries, Jan K Buitelaar, Christopher Gillberg, Alessandro Zuddas, Shuyu Zhang, Joseph Biederman
    Abstract:

    ABSTRACT Objective Attention-deficit/hyperactivity disorder (ADHD) is typically treated over extended periods; however, few placebo-controlled, long-term studies of efficacy have been reported. Method In a global multicenter study, children and adolescents who responded to an initial 12-week, open-label period of treatment with Atomoxetine, a nonstimulant treatment for ADHD, were randomized to continued Atomoxetine treatment or placebo for 9 months under double-blind conditions. Results A total of 416 patients completed acute Atomoxetine treatment and were randomized. At end point, Atomoxetine was superior to placebo in preventing relapse defined as a return to 90% of baseline symptom severity (proportion relapsing: Atomoxetine 65 of 292 [22.3%], placebo 47 of 124 [37.9%], p = .002). The proportion of patients with a 50% worsening in symptoms post-randomization was also lower on Atomoxetine (Atomoxetine 83 of 292 [28.4%], placebo 59 of 124 [47.6%], p Conclusions In patients who responded favorably to 12 weeks of initial treatment, Atomoxetine was superior to placebo in maintaining response for the ensuing 9 months. This result supports the value of maintenance treatment with Atomoxetine in patients with ADHD who respond to initial treatment.

  • Atomoxetine pharmacokinetics in children and adolescents with attention deficit hyperactivity disorder
    Journal of Child and Adolescent Psychopharmacology, 2003
    Co-Authors: Jennifer Witcher, Thomas J Spencer, Johnmichael Sauer, Timothy E Wilens, Amanda Long, Brian P Smith, John Heilgenstein, Joseph Biederman
    Abstract:

    Objective: Atomoxetine is indicated for the treatment of attention deficit hyperactivity disorder in children, adolescents, and adults. This study was conducted, in part, to evaluate the single-dose and steady-state pharmacokinetics of Atomoxetine in pediatric patients. Methods: This was an open-label, dose-titration study in pediatric patients with attention deficit hyperactivity disorder. Eligible patients could elect to participate in a single-dose or steady-state discontinuation pharmacokinetic evaluation including serial plasma sample collection over 24 hours. Plasma concentrations of Atomoxetine, 4-hydroxyAtomoxetine, and N-desmethylAtomoxetine were determined using an atmospheric pressure chemical ionization liquid chromatography/mass spectrometry/mass spectrometry assay. Pharmacokinetic parameters were calculated using noncompartmental analysis. Results: Twenty-one cytochrome P450 2D6 extensive metabolizer patients participated in these single-dose and steady-state pharmacokinetic evaluations. Ato...

David Michelson - One of the best experts on this subject based on the ideXlab platform.

  • Atomoxetine treatment of adults with adhd and comorbid alcohol use disorders
    Drug and Alcohol Dependence, 2008
    Co-Authors: Timothy E Wilens, Rodney J Moore, David Michelson, Lenard A Adler, Paula T Trzepacz, Margaret D Weiss, Janet L Ramsey, Didier Renard, Kathleen T Brady, Leslie M Schuh
    Abstract:

    Objective Adults with attention-deficit/hyperactivity disorder (ADHD) have higher rates of alcohol and drug use disorders than adults without ADHD. The study aim was to determine if Atomoxetine was superior to placebo in improving ADHD and alcohol use in recently abstinent adults with ADHD and comorbid alcohol use disorder. Methods Adults with DSM-IV diagnoses of ADHD and alcohol abuse and/or dependence were abstinent from alcohol at least 4 days (maximum 30 days) before study randomization. Participants received Atomoxetine (25–100 mg daily) or placebo for 12 weeks. ADHD symptoms were assessed using ADHD Investigator Symptom Rating Scale (AISRS) total score. Time-to-relapse to heavy alcohol use was analyzed using a 2-sided log-rank test based on Kaplan–Meier estimates and cumulative heavy drinking events over time were evaluated post hoc with recurrent-event analysis. Results Subjects received Atomoxetine (n = 72) or placebo (n = 75) and 80 subjects completed the 12-week double-blind period (n = 32 and 48, respectively). ADHD symptoms were significantly improved in the Atomoxetine cohort compared to placebo (AISRS total score mean [S.D.], Atomoxetine: −13.63 [11.35], P < .001; placebo: −8.31 [11.44], P < .001, difference: P = .007; effect size = 0.48). No significant differences between treatment groups occurred in time-to-relapse of heavy drinking (P = .93). However, cumulative heavy drinking days were reduced 26% in Atomoxetine-treated subjects versus placebo (event ratio = 0.74, P = .023). There were no serious adverse events or specific drug–drug reactions related to current alcohol use. Conclusions This 3-month, double-blind, placebo-controlled study of Atomoxetine in adults with ADHD and comorbid alcohol use disorder demonstrates clinically significant ADHD improvement, and inconsistent effects on drinking behavior.

  • Atomoxetine and osmotically released methylphenidate for the treatment of attention deficit hyperactivity disorder acute comparison and differential response
    American Journal of Psychiatry, 2008
    Co-Authors: Jeffrey H Newcorn, Christopher J Kratochvil, Rodney J Moore, Charles D Casat, Albert J Allen, Dustin D Ruff, David Michelson
    Abstract:

    Objective: Response to Atomoxetine, a nonstimulant norepinephrine-specific reuptake inhibitor, was compared with the effect of osmotic-release oral methylphenidate, a long-acting methylphenidate preparation, in patients with attention deficit hyperactivity disorder (ADHD). Method: In a large placebo-controlled, double-blind study, patients ages 6–16 with ADHD, any subtype, were randomly assigned to receive 0.8–1.8 mg/kg per day of Atomoxetine (N=222), 18–54 mg/day of osmotically released methylphenidate (N=220), or placebo (N=74) for 6 weeks. The a priori specified primary analysis compared response (at least 40% decrease in ADHD Rating Scale total score) to osmotically released methylphenidate with response to Atomoxetine and placebo. After 6 weeks, patients treated with methylphenidate were switched to Atomoxetine under double-blind conditions. Results: The response rates for both Atomoxetine (45%) and methylphenidate (56%) were markedly superior to that for placebo (24%), but the response to osmoticall...

  • cyp2d6 and clinical response to Atomoxetine in children and adolescents with adhd
    Journal of the American Academy of Child and Adolescent Psychiatry, 2007
    Co-Authors: David Michelson, Shuyu Zhang, Dustin D Ruff, Holly Ann Read, Jennifer Witcher, James T Mccracken
    Abstract:

    ABSTRACT Background Atomoxetine, a selective norepinephrine reuptake inhibitor effective in the treatment of attention-deficit/hyperactivity disorder (ADHD), is metabolized through the cytochrome P-450 2D6 (CYP2D6) enzyme pathway, which is genetically polymorphic in humans. Variations in plasma Atomoxetine exposures can occur because of genetic variation or as a consequence of coadministration with drugs that inhibit CYP2D6. Method We examined the effects of CYP2D6 on the efficacy, safety, and tolerability of Atomoxetine in children and adolescents using pooled data from Atomoxetine clinical trials. Results At endpoint, poor metabolizers had markedly greater reductions in mean symptom severity scores compared with extensive metabolizers ( p p p p Conclusions These results suggest that CYP2D6 poor metabolizers taking Atomoxetine in doses up to 1.8 mg/kg/day are likely to have greater efficacy, greater increases in cardiovascular tone, and some differences in tolerability compared with CYP2D6 extensive metabolizers taking similar doses.

  • Atomoxetine and stroop task performance in adult attention deficit hyperactivity disorder
    Journal of Child and Adolescent Psychopharmacology, 2005
    Co-Authors: Stephen V Faraone, Thomas J Spencer, Joseph Biederman, David Michelson, Lenard A Adler, Frederick W Reimherr, Larry J Seidman
    Abstract:

    Objective: The aim of this study was to assess the efficacy of Atomoxetine, a new and highly selective inhibitor of the norepinephrine transporter, for executive functioning in adults with attention-deficit/hyperactivity disorder (ADHD). Method: Two identical studies using a double-blind, placebo-controlled, parallel design were conducted. Patients were adults (Study 1, n = 280; Study 2, n = 256) with Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)-defined ADHD recruited by referral and advertising. They were randomized to 10 weeks of treatment with Atomoxetine or placebo. Executive functions were measured by the Stroop task. Results: There was no evidence of cognitive deterioration associated with Atomoxetine treatment. Atomoxetine treatment was associated with an improvement of the Stroop colorword score. Conclusions: Our results provide further support for Spencer et al.'s (1998) report that Atomoxetine improves inhibitory capacity, as measured by the Stroop task. The absenc...

  • Atomoxetine alone or combined with fluoxetine for treating adhd with comorbid depressive or anxiety symptoms
    Journal of the American Academy of Child and Adolescent Psychiatry, 2005
    Co-Authors: Christopher J Kratochvil, Jeffrey H Newcorn, Eugene L Arnold, David A Duesenberg, Graham J Emslie, Humberto Quintana, Elias H Sarkis, Karen Dineen Wagner, Haitao Gao, David Michelson
    Abstract:

    ABSTRACT Objective Symptoms of depression and anxiety are commonly comorbid with attention-deficit/hyperactivity disorder (ADHD). The authors assessed the safety and effectiveness of Atomoxetine monotherapy compared with combined Atomoxetine/fluoxetine therapy in a population of children and adolescents with ADHD and concurrent symptoms of depression or anxiety. Method Patients were randomized to treatment with fluoxetine ( n = 127) or placebo ( n = 46) under double-blind conditions for 8 weeks, with concomitant Atomoxetine use the last 5 weeks. Results At end point, reductions in ADHD, depressive, and anxiety symptoms were marked for both treatment groups ( p Conclusions In pediatric patients with ADHD and comorbid symptoms of depression or anxiety, Atomoxetine monotherapy appears to be effective for treating ADHD. Anxiety and depressive symptoms also improved, but the absence of a placebo-only arm does not allow us to conclude that these effects are specifically the result of treatment with Atomoxetine. Combined Atomoxetine/fluoxetine therapy was well tolerated.

Thomas J Spencer - One of the best experts on this subject based on the ideXlab platform.

  • once daily Atomoxetine for adult attention deficit hyperactivity disorder a 6 month double blind trial
    Journal of Clinical Psychopharmacology, 2009
    Co-Authors: Lenard A Adler, Kory Schuh, Thomas J Spencer, Thomas E Brown, James Holdnack, Keith E Saylor, Paula T Trzepacz, David W Williams, Douglas Kelsey
    Abstract:

    This randomized, double-blind, placebo-controlled, 6-month trial examined the efficacy and safety of once-daily morning-dosed Atomoxetine in adult patients with attention-deficit/hyperactivity disorder (ADHD) and the efficacy of Atomoxetine in ameliorating symptoms through the evening hours. Patients received once-daily Atomoxetine (n = 250) or placebo (n = 251) in the morning for approximately 6 months. The efficacy measures included the Adult ADHD Investigator Symptom Rating Scale (AISRS), Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version, Clinical Global Impressions-ADHD-Severity of Illness, and Adult ADHD Quality of Life Scale. Overall, 94 patients randomized to Atomoxetine and 112 patients randomized to placebo completed the study. On the AISRS total score, Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version evening index total score, Clinical Global Impressions-ADHD-Severity of Illness score, and Adult ADHD Quality of Life Scale total score, Atomoxetine was statistically superior to placebo at the 10-week and 6-month time points. From the visitwise analysis, the mean (SD) AISRS total scores for Atomoxetine decreased from 38.2 (7.5) at baseline to 21.4 (12.3) at the 6-month end point compared with 38.6 (7.0) to 25.8 (13.2) for placebo (P = 0.035). Nausea, dry mouth, fatigue, decreased appetite, urinary hesitation, and erectile dysfunction were the treatment-emergent adverse events reported significantly more often with Atomoxetine. Discontinuations due to adverse events were 17.2% and 5.6% for Atomoxetine and placebo, respectively (P < 0.001). Once-daily morning-dosed Atomoxetine is efficacious for treating ADHD in adults when measured 10 weeks and 6 months after initiating treatment. Atomoxetine demonstrated significant efficacy that continued into the evening. Adverse events were similar to previous trials.

  • a post hoc subgroup analysis of an 18 day randomized controlled trial comparing the tolerability and efficacy of mixed amphetamine salts extended release and Atomoxetine in school age girls with attention deficit hyperactivity disorder
    Clinical Therapeutics, 2006
    Co-Authors: Joseph Biederman, Thomas J Spencer, Sharon B Wigal, James J Mcgough, David A Mays
    Abstract:

    Abstract Background: Because the scientific literature on the pharmacotherapy of attention-deficit/hyperactivity disorder (ADHD) is almost entirely based on the results of studies in samples consisting primarily of boys, much is unknown about the treatment response in girls. Objective: This post hoc analysis compared the efficacy, tolerability, and time course of the effect of mixed amphetamine salts extended release (MAS XR) and Atomoxetine in school-age girls with ADHD. Methods: This was an intent-to-treat subanalysis of the data from girls enrolled in a multicenter, 18-day, randomized, double-blind, parallel-group, forced dosetitration, laboratory school study enrolling boys and girls aged 6 to 12 years with ADHD. The study compared the efficacy, tolerability, and time course of the effect of increasing doses of MAS XR (10, 20, and 30 mg/d) and Atomoxetine (0.5 and 1.2 mg/kg per day). The laboratory school sessions were organized in cycles to include 12 hours of observation. Efficacy measures included the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) deportment rating subscale, the SKAMP attention rating subscale, and academic testing (number of math problems attempted and answered correctly). Adverse events were assessed throughout the study period. Tolerability and efficacy measures were assessed during laboratory school visits on days 7, 14, and 21. Results: This subanalysis included 57 girls (median age, 9 years; 49.1% white, 22.8% black, 17.5% Hispanic) with a diagnosis of ADHD, combined subtype. Twenty-six girls were randomized to receive MAS XR and 31 were randomized to receive Atomoxetine. Mean SKAMP deportment and attention subscale scores in the 2 groups were similar at baseline. Mean changes from baseline were significantly greater for MAS XR compared with Atomoxetine on the SKAMP deportment score (−0.48 vs −0.04, respectively; P P P P P =0.04). Both MAS XR and Atomoxetine were well tolerated. The most frequently occurring treatment-related adverse events in girls receiving MAS XR were decreased appetite (40.7%), upper abdominal pain (29.6%), insomnia (25.9%), and headache (14.8%). The most frequently occurring treatment-related adverse events in girls receiving Atomoxetine were somnolence (28.1%), upper abdominal pain (15.6%), vomiting (15.6%), nausea (12.5%), and decreased appetite (12.5%). Conclusion: This post hoc analysis in a subpopulation of girls with ADHD, combined subtype, found that 18-day treatment with MAS XR was significantly more effective than Atomoxetine in terms of ratings of classroom behavior, attention, and academic productivity.

  • Atomoxetine and stroop task performance in adult attention deficit hyperactivity disorder
    Journal of Child and Adolescent Psychopharmacology, 2005
    Co-Authors: Stephen V Faraone, Thomas J Spencer, Joseph Biederman, David Michelson, Lenard A Adler, Frederick W Reimherr, Larry J Seidman
    Abstract:

    Objective: The aim of this study was to assess the efficacy of Atomoxetine, a new and highly selective inhibitor of the norepinephrine transporter, for executive functioning in adults with attention-deficit/hyperactivity disorder (ADHD). Method: Two identical studies using a double-blind, placebo-controlled, parallel design were conducted. Patients were adults (Study 1, n = 280; Study 2, n = 256) with Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV)-defined ADHD recruited by referral and advertising. They were randomized to 10 weeks of treatment with Atomoxetine or placebo. Executive functions were measured by the Stroop task. Results: There was no evidence of cognitive deterioration associated with Atomoxetine treatment. Atomoxetine treatment was associated with an improvement of the Stroop colorword score. Conclusions: Our results provide further support for Spencer et al.'s (1998) report that Atomoxetine improves inhibitory capacity, as measured by the Stroop task. The absenc...

  • A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and Atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder.
    Journal of Attention Disorders, 2005
    Co-Authors: Sharon B Wigal, Thomas J Spencer, Joseph Biederman, James T Mccracken, James J Mcgough, Kelly Posner, Timothy Wigal, Scott H. Kollins, Tanya M. Clark, David A Mays
    Abstract:

    Mixed amphetamine salts extended release (MAS XR; Adderall XR®) and Atomoxetine (Strattera®) were compared in children 6 to 12 years old with attention deficit/hyperactivity disorder (ADHD) combined or hyperactive/impulsive type in a randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study. Primary efficacy measure was the SKAMP (Swanson, Kotkin, Agler, M-Flynn, and Pelham) behavioral rating scale. Changes in mean SKAMP deportment scores from baseline were significantly greater for MAS XR (n = 102) than for Atomoxetine (n = 101) overall (-0.56 and -0.13, respectively; p < .0001) and at each week (p < .001). Adverse events were similar for both treatment groups. The extended time course of action and greater therapeutic efficacy of MAS XR suggests that it is more effective than Atomoxetine in children with ADHD.

  • relapse prevention in pediatric patients with adhd treated with Atomoxetine a randomized double blind placebo controlled study
    Journal of the American Academy of Child and Adolescent Psychiatry, 2004
    Co-Authors: David Michelson, Marina Danckaerts, Thomas J Spencer, Douglas E Faries, Jan K Buitelaar, Christopher Gillberg, Alessandro Zuddas, Shuyu Zhang, Joseph Biederman
    Abstract:

    ABSTRACT Objective Attention-deficit/hyperactivity disorder (ADHD) is typically treated over extended periods; however, few placebo-controlled, long-term studies of efficacy have been reported. Method In a global multicenter study, children and adolescents who responded to an initial 12-week, open-label period of treatment with Atomoxetine, a nonstimulant treatment for ADHD, were randomized to continued Atomoxetine treatment or placebo for 9 months under double-blind conditions. Results A total of 416 patients completed acute Atomoxetine treatment and were randomized. At end point, Atomoxetine was superior to placebo in preventing relapse defined as a return to 90% of baseline symptom severity (proportion relapsing: Atomoxetine 65 of 292 [22.3%], placebo 47 of 124 [37.9%], p = .002). The proportion of patients with a 50% worsening in symptoms post-randomization was also lower on Atomoxetine (Atomoxetine 83 of 292 [28.4%], placebo 59 of 124 [47.6%], p Conclusions In patients who responded favorably to 12 weeks of initial treatment, Atomoxetine was superior to placebo in maintaining response for the ensuing 9 months. This result supports the value of maintenance treatment with Atomoxetine in patients with ADHD who respond to initial treatment.

Albert J Allen - One of the best experts on this subject based on the ideXlab platform.

  • safety and tolerability of Atomoxetine hydrochloride in a long term placebo controlled randomized withdrawal study in european and non european adults with attention deficit hyperactivity disorder
    European Journal of Psychiatry, 2013
    Co-Authors: A Camporeale, Paula T Trzepacz, Himanshu P Upadhyaya, Antoni J Ramosquiroga, David J Williams, Yoko Tanaka, Jeannine R Lane, Rodrigo Escobar, Albert J Allen
    Abstract:

    ABSTRACT � Background and Objectives: Safety and tolerability of Atomoxetine were studied in the largest double-blind, placebo-controlled, randomised withdrawal trial of Atomoxetine (80 or 100 mg/day) in adults with attention-deficit/hyperactivity disorder (ADHD). Methods: Patients (N = 2017), 18 to 50 years of age, with ADHD were enrolled from 18 countries. Patients who responded to Atomoxetine during a 12-week open-label treatment phase and maintained that response during a 12-week double-blind maintenance phase were randomised to Atomoxetine (N = 266) or placebo (N = 258) for 25 weeks of double-blind treatment. Treatment differences were compared for serious adverse events (AEs), treatment-emergent AEs (TEAEs), discontinuation due to AEs, vital signs, body weight, and electrocardiograms. Results: During the 25-week double-blind treatment phase, discontinuations due to AEs were similar between Atomoxetine and placebo (3.4% vs. 1.9%; P = .418). The percentage of patients experiencing .1 TEAE(s) was significantly higher for Atomoxetine than placebo (47.0% vs. 37.6%; P = .034), but there were no significant differences for any individual TEAE. Diastolic blood pressure (-0.1 vs. -2.3 mmHg), heart rate (-1.4 vs. -5.3 bpm), and weight (-0.2 vs. 1.1 kg) were significantly different between Atomoxetine and placebo (P <.001). There were no significant differences between Atomoxetine and placebo in the frequencies of patients showing an increase from baseline >30 ms in Fridericia�fs QT correction (QTcF; 1.4% vs. 2.6%) or Bazett�fs QT correction (QTcB; 2.8% vs. 2.6%). During the entire study, no patient had a QTcF or QTcB >500 ms, or an increase from baseline >60 ms. Conclusions: This study demonstrated that Atomoxetine exhibited an acceptable safety profile in adults with ADHD after 1 year of treatment, and no clinically meaningful safety- related rebound effects were observed following abrupt discontinuation after 24 weeks of treatment.

  • a haplotype of the norepinephrine transporter net gene slc6a2 is associated with clinical response to Atomoxetine in attention deficit hyperactivity disorder adhd
    Neuropsychopharmacology, 2009
    Co-Authors: Nicolas Ramoz, Albert J Allen, Claudette Boni, Anncatherine M Downing, Sandra L Close, Sandra L Peters, Angela M Prokop, Michel Hamon, Diane Purperouakil, Philip Gorwood
    Abstract:

    Atomoxetine is a specific inhibitor of the norepinephrine transporter (NET) that has demonstrated efficacy in the treatment of children with attention-deficit hyperactivity disorder (ADHD). We investigated whether polymorphisms in the NET/SLC6A2 gene may influence Atomoxetine response in ADHD. Two independent cohorts of 160 and 105 ADHD children treated for 6 weeks with Atomoxetine (0.5–1.8 mg/kg per day) were genotyped on CYP2D6, which metabolizes Atomoxetine, and 108 single nucleotide polymorphisms in the NET/SLC6A2 gene. Response was defined as a minimum decrease of 25% in ADHD Rating Scale IV-Parent Version and a Clinical Global Impression-Severity (CGI-S) score less than or equal to 2 at week 6. Interindividual response was independent of the genetic variants of CYP2D6. Significant (p<0.05) associations between 20 NET/SLC6A2 single nucleotide polymorphisms (SNPs) and clinical efficacy in Atomoxetine responders, compared with non-responders, were observed. The genomic region across exons 4 to 9 of NET/SLC6A2, where 36 SNPs have been genotyped, was associated with treatment response in both cohorts (p<0.01, odds ratio=2.2 and p=0.026, odds ratio=6.3, respectively), in the combined cohort (p<0.01, odds ratio=1.83), and in the subgroup of Caucasians only (p=0.02, odds ratio=1.8). Clinical efficacy of Atomoxetine treatment in ADHD shows potential dependence upon a series of genetic polymorphisms of its mechanistic target, the norepinephrine transporter. Taking into account the high heritability of ADHD, the significance of the present finding and replication of a similar haplotype allele sequence result in an independent cohort, it is suggested that further assessment of this region could be useful in determining response to Atomoxetine in ADHD.

  • Atomoxetine and osmotically released methylphenidate for the treatment of attention deficit hyperactivity disorder acute comparison and differential response
    American Journal of Psychiatry, 2008
    Co-Authors: Jeffrey H Newcorn, Christopher J Kratochvil, Rodney J Moore, Charles D Casat, Albert J Allen, Dustin D Ruff, David Michelson
    Abstract:

    Objective: Response to Atomoxetine, a nonstimulant norepinephrine-specific reuptake inhibitor, was compared with the effect of osmotic-release oral methylphenidate, a long-acting methylphenidate preparation, in patients with attention deficit hyperactivity disorder (ADHD). Method: In a large placebo-controlled, double-blind study, patients ages 6–16 with ADHD, any subtype, were randomly assigned to receive 0.8–1.8 mg/kg per day of Atomoxetine (N=222), 18–54 mg/day of osmotically released methylphenidate (N=220), or placebo (N=74) for 6 weeks. The a priori specified primary analysis compared response (at least 40% decrease in ADHD Rating Scale total score) to osmotically released methylphenidate with response to Atomoxetine and placebo. After 6 weeks, patients treated with methylphenidate were switched to Atomoxetine under double-blind conditions. Results: The response rates for both Atomoxetine (45%) and methylphenidate (56%) were markedly superior to that for placebo (24%), but the response to osmoticall...

  • abuse liability assessment of Atomoxetine in a drug abusing population
    Drug and Alcohol Dependence, 2008
    Co-Authors: Donald R Jasinski, Rodney J Moore, Douglas E Faries, Leslie M Schuh, Albert J Allen
    Abstract:

    Abstract Background Atomoxetine is a non-amphetamine medication approved to treat ADHD in children, adolescents, and adults. Previous studies demonstrated low abuse potential for Atomoxetine in recreational drug users. This study assessed the abuse potential of Atomoxetine in stimulant-preferring drug abusers compared to methylphenidate and phentermine as positive controls and desipramine and placebo as negative controls. Methods Forty male and female, 32–53 years old stimulant-preferring drug abusers completed this balanced Latin-square designed study. Subjects received acute, double-blind doses of placebo, desipramine (100 and 200 mg), methylphenidate (90 mg), phentermine (60 mg), and Atomoxetine (45, 90, and 180 mg). Subjective and physiological effects were collected for 24 h following each drug treatment. Results Methylphenidate and phentermine were liked significantly more than placebo, Atomoxetine, or desipramine. No Atomoxetine dose was liked significantly more than placebo and liking scores for Atomoxetine were similar to, or significantly lower than, desipramine, as assessed by the Drug Rating Questionnaire-Subject. While Atomoxetine 45 and 180 mg did not significantly change any Addiction Research Center Inventory (ARCI) scores, Atomoxetine 90 mg significantly increased A and BG stimulant scores of the ARCI and both methylphenidate and phentermine produced greater A and BG increases than any Atomoxetine dose and also increased MBG (euphoria) scores relative to placebo. Conclusions Atomoxetine has significantly less abuse liability than methylphenidate or phentermine and no greater abuse liability than desipramine.

  • meta analysis of suicide related behavior events in patients treated with Atomoxetine
    Journal of the American Academy of Child and Adolescent Psychiatry, 2008
    Co-Authors: Mark E Bangs, Shuyu Zhang, Paula T Trzepacz, Sitra Tauscherwisniewski, John Polzer, Nayan Acharya, Durisala Desaiah, Albert J Allen
    Abstract:

    ABSTRACT Objective: The present work examined suicide-related events in acute, double-blind, and placebo- or active comparator-controlled trials with Atomoxetine. Method: Fourteen trials in pediatric patients were included. Potential events were identified in the adverse events database using a text-string search. Potential suicide-related events were categorized according to U.S. Food and Drug Administration-defined codes using blinded patient summaries. The meta-analyses used the Mantel-Haenszel incidence difference and Mantel-Haenszel risk ratio methods. Results: No patient in Atomoxetine attention-deficit/hyperactivity disorder (ADHD) trials committed suicide. The frequency of suicidal ideation was 0.37% (5/1357) in pediatric patients taking Atomoxetine versus 0% (0/851) for the placebo group; Mantel-Haenszel incidence difference of 0.46 (95% confidence interval 0.09-0.83; p =.016) and Mantel-Haenszel risk ratio of 2.92 (95% confidence interval 0.63-13.57; p =.172). Frequencies of suicide-related events in pediatric patients with ADHD did not differ between methylphenidate and Atomoxetine treatments (Mantel-Haenszel incidence difference of −0.12 (95% confidence interval −0.62 to 0.38; p =.649). The number needed to harm in pediatric patients for an additional suicide-related event is 227 compared to the number needed to treat of five to achieve remission of ADHD symptoms. Conclusions: Although uncommon, suicidal ideation was significantly more frequent in pediatric ADHD patients treated with Atomoxetine compared to those treated with placebo. Retrospective analysis has limitations in ascertaining intent.

Christopher J Kratochvil - One of the best experts on this subject based on the ideXlab platform.

  • Atomoxetine and osmotically released methylphenidate for the treatment of attention deficit hyperactivity disorder acute comparison and differential response
    American Journal of Psychiatry, 2008
    Co-Authors: Jeffrey H Newcorn, Christopher J Kratochvil, Rodney J Moore, Charles D Casat, Albert J Allen, Dustin D Ruff, David Michelson
    Abstract:

    Objective: Response to Atomoxetine, a nonstimulant norepinephrine-specific reuptake inhibitor, was compared with the effect of osmotic-release oral methylphenidate, a long-acting methylphenidate preparation, in patients with attention deficit hyperactivity disorder (ADHD). Method: In a large placebo-controlled, double-blind study, patients ages 6–16 with ADHD, any subtype, were randomly assigned to receive 0.8–1.8 mg/kg per day of Atomoxetine (N=222), 18–54 mg/day of osmotically released methylphenidate (N=220), or placebo (N=74) for 6 weeks. The a priori specified primary analysis compared response (at least 40% decrease in ADHD Rating Scale total score) to osmotically released methylphenidate with response to Atomoxetine and placebo. After 6 weeks, patients treated with methylphenidate were switched to Atomoxetine under double-blind conditions. Results: The response rates for both Atomoxetine (45%) and methylphenidate (56%) were markedly superior to that for placebo (24%), but the response to osmoticall...

  • long term Atomoxetine treatment in adolescents with attention deficit hyperactivity disorder
    The Journal of Pediatrics, 2006
    Co-Authors: Timothy E Wilens, Christopher J Kratochvil, Jeffrey H Newcorn, Haitao Gao, C Thomason, Ann K Rogers, Peter D Feldman, Louise R Levine
    Abstract:

    Objective To determine the efficacy and safety of Atomoxetine in adolescent subjects treated for attention-deficit/hyperactivity disorder (ADHD) for up to 2 years. Study design Data from 13 Atomoxetine studies (6 double-blind, 7 open-label) were pooled for subjects age 12 to 18 with ADHD as defined by the American Psychiatric Association’s Diagnostic and Statistical Manual of Mental Disorders IV. Results Of the 601 Atomoxetine-treated subjects in this meta-analysis, 537 (89.4%) completed 3 months of acute treatment. A total of 259 subjects (48.4%) are continuing Atomoxetine treatment; 219 of these subjects have completed at least 2 years of treatment. The mean dose of Atomoxetine at endpoint was 1.41 mg/kg/day. Mean ADHD Rating Scale IV, parent version, investigator-administered and -scored total scores showed significant improvement (P Conclusions Two-year data from this ongoing study indicate that Atomoxetine maintains efficacy among adolescents with ADHD, with no evidence of drug tolerance and no new or unexpected safety concerns.

  • Atomoxetine alone or combined with fluoxetine for treating adhd with comorbid depressive or anxiety symptoms
    Journal of the American Academy of Child and Adolescent Psychiatry, 2005
    Co-Authors: Christopher J Kratochvil, Jeffrey H Newcorn, Eugene L Arnold, David A Duesenberg, Graham J Emslie, Humberto Quintana, Elias H Sarkis, Karen Dineen Wagner, Haitao Gao, David Michelson
    Abstract:

    ABSTRACT Objective Symptoms of depression and anxiety are commonly comorbid with attention-deficit/hyperactivity disorder (ADHD). The authors assessed the safety and effectiveness of Atomoxetine monotherapy compared with combined Atomoxetine/fluoxetine therapy in a population of children and adolescents with ADHD and concurrent symptoms of depression or anxiety. Method Patients were randomized to treatment with fluoxetine ( n = 127) or placebo ( n = 46) under double-blind conditions for 8 weeks, with concomitant Atomoxetine use the last 5 weeks. Results At end point, reductions in ADHD, depressive, and anxiety symptoms were marked for both treatment groups ( p Conclusions In pediatric patients with ADHD and comorbid symptoms of depression or anxiety, Atomoxetine monotherapy appears to be effective for treating ADHD. Anxiety and depressive symptoms also improved, but the absence of a placebo-only arm does not allow us to conclude that these effects are specifically the result of treatment with Atomoxetine. Combined Atomoxetine/fluoxetine therapy was well tolerated.

  • a randomized placebo controlled study of once daily Atomoxetine in the school setting in children with adhd
    Journal of the American Academy of Child and Adolescent Psychiatry, 2005
    Co-Authors: Margaret D Weiss, Douglas Kelsey, Christopher J Kratochvil, C Thomason, David W Dunn, Rosemary Tannock, Jesus Velezborras, Roy N Tamura, Linda Stevens, Albert J Allen
    Abstract:

    ABSTRACT Objective Five studies have demonstrated the effectiveness of Atomoxetine compared with placebo in reducing symptoms of attention-deficit/hyperactivity disorder (ADHD) based on parent reports. The primary objective of this clinical trial was to assess the efficacy of once-daily Atomoxetine compared with placebo using teacher reports. Method One hundred fifty-three patients aged 8-12 years were randomly assigned to receive once-daily Atomoxetine or placebo in a 2:1 ratio for 7 weeks. ADHD symptoms at school were primarily assessed by baseline-to-endpoint change on the Attention-Deficit/Hyperactivity Disorder Rating Scale-IV-Teacher Version: Investigator administered and scored (ADHDRS-IV-Teacher:Inv) as rated by investigators using teacher reports. Results ADHDRS-IV-Teacher:Inv total scores were significantly lower for children treated with Atomoxetine compared with those treated with placebo ( p = .001). Similar results were observed for the inattentive ( p = .016) and hyperactive/impulsive ( p p = .001), the Conners Global Index-Teacher scale ( p = .008), and the Conners Parent Rating Scale-Revised: Short Form ADHD Index T-Score ( p p = .096). Conclusions This study extends previous results based on parent reports showing that once-daily administration of Atomoxetine is safe and effective in improving ADHD symptoms in children and demonstrates that outcomes at school are similar when symptoms are reported by teachers.

  • improvement in health related quality of life in children with adhd an analysis of placebo controlled studies of Atomoxetine
    Journal of Developmental and Behavioral Pediatrics, 2004
    Co-Authors: Amy R Perwien, Calvin Russell Sumner, Douglas Kelsey, Christopher J Kratochvil, Douglas E Faries, Albert J Allen
    Abstract:

    Despite significant functional impairments associated with attention-deficit hyperactivity disorder (ADHD) and the growing appreciation of the importance of health-related quality of life (HRQL) assessment in children with chronic disorders, relatively few studies have examined the impact of ADHD treatment on HRQL. This investigation examines the effect of Atomoxetine, a nonstimulant treatment for ADHD, on HRQL and identifies factors that are predictive of HRQL improvements. The Child Health Questionnaire (CHQ), which is a multidimensional HRQL measure, was collected during three randomized, double-blind, placebo-controlled clinical trials. Children who received Atomoxetine had significantly greater improvement in psychosocial functioning compared to the placebo group. No significant differences between once-a-day and twice-a-day dosing were found. Treatment with Atomoxetine, lower HRQL baseline score, no history of stimulant use, and absence of oppositional defiant disorder were all associated with improvements in psychosocial functioning. Findings demonstrate the positive impact of Atomoxetine on HRQL in children with ADHD.