The Experts below are selected from a list of 2079 Experts worldwide ranked by ideXlab platform
Mark Adams - One of the best experts on this subject based on the ideXlab platform.
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Physical Signs of Adderall Addiction | Adderall Addiction Treatment
2018Co-Authors: Mark AdamsAbstract:Knowing the physical signs of Adderall addiction can help you decide whether you need help ending an addiction to Adderall.
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physical signs of Adderall addiction Adderall addiction treatment
2018Co-Authors: Mark AdamsAbstract:Knowing the physical signs of Adderall addiction can help you decide whether you need help ending an addiction to Adderall.
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20 symptoms of Adderall abuse effects of Adderall abuse
2018Co-Authors: Mark AdamsAbstract:Adderall can help with focusing in children and adolescents, but the use of the drug is rife with abuse. Here we discuss the most common symptoms of Adderall abuse.
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Spotting Teen Adderall Abuse | Adderall Addiction Symptoms
2017Co-Authors: Mark AdamsAbstract:Teen Adderall abuse can lead to addiction and dependence and all of the problems that come with it. Learn how to spot it - and how to get help.
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spotting teen Adderall abuse Adderall addiction symptoms
2017Co-Authors: Mark AdamsAbstract:Teen Adderall abuse can lead to addiction and dependence and all of the problems that come with it. Learn how to spot it - and how to get help.
James M. Swanson - One of the best experts on this subject based on the ideXlab platform.
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a pharmacokinetic pharmacodynamic study comparing a single morning dose of Adderall to twice daily dosing in children with adhd
Journal of the American Academy of Child and Adolescent Psychiatry, 2003Co-Authors: Laurence L. Greenhill, James M. Swanson, Sharon B. Wigal, Marc Lerner, Yuxin Zhang, Kelly Posner, Ken Steinhoff, Jane Fried, Susan B. Clausen, Simon J. TullochAbstract:Objective To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall®. Method Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l- amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. Results The pharmacokinetic profiles revealed similar morning concentrations of d - and l -amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition ( p Conclusions This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.
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Pharmacokinetics of SLI381 (Adderall XR), an extended-release formulation of Adderall.
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: James J. Mcgough, Sharon B. Wigal, Laurence L. Greenhill, Simon J. Tulloch, Thomas J. Spencer, Joseph Biederman, James T. Mccracken, Kelly Posner, Jeffrey Gornbein, James M. SwansonAbstract:ABSTRACT Objective To assess the pharmacokinetic (PK) properties of a single daily dose of Adderall ® (mixed amphetamine salts) and the extended-release formulation, SLI381 (Adderall XR™), in pediatric attention-deficit/hyperactivity disorder (ADHD). Method Fifty-one children (aged 6–12 years) with ADHD participated in a 6-week, seven-visit, PK and pharmacodynamic study. PK sampling occurred during visit 1 and again at visit 7. At visit 1, subjects received an initial oral dose of SLI381, 20 mg. At visit 7 subjects completed 1 week of medication treatment following random assignment to once-daily orally dosed SLI381 10 mg, 20 mg, or 30 mg; Adderall 10 mg; or placebo. Results PK parameters evidenced substantial intersubject variability (coefficients of variation=28–56%). Time to maximum concentration (T max ) for SLI381 versus Adderall showed average increases of 3.0 hours for dextroamphetamine ( t = −2.35, p = .04, df = 8.6) and 3.2 hours for levoamphetamine ( t = −2.39, p = .04, df = 9.2). The d - and l -isomer concentrations were highly correlated and approximated a 3:1 ratio. Conclusions SLI381 showed extended T max values compared with Adderall and appears suitable for once-daily dosing. Intersubject variability underscores the need for individual dose titration.
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A Pharmacokinetic/Pharmacodynamic Study Comparing a Single Morning Dose of Adderall to Twice-Daily Dosing in Children With ADHD
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: Laurence L. Greenhill, James M. Swanson, Sharon B. Wigal, Marc Lerner, Yuxin Zhang, Kelly Posner, Ken Steinhoff, Jane Fried, Susan B. Clausen, Simon J. TullochAbstract:Objective To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall®. Method Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l- amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. Results The pharmacokinetic profiles revealed similar morning concentrations of d - and l -amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition ( p Conclusions This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.
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Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD.
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: James T. Mccracken, James M. Swanson, Sharon B. Wigal, Laurence L. Greenhill, Thomas J. Spencer, Joseph Biederman, James J. Mcgough, Kelly Posner, Caroly Pataki, Yuxin ZhangAbstract:ABSTRACT Objectives This investigation was conducted primarily to assess the safety and efficacy of SLI381 (Adderall XR™), developed as a once-daily treatment for children with attention-deficit/hyperactivity disorder (ADHD). Secondary objectives included examination of the time course, pharmacokinetic, and pharmacodynamic properties of SLI381. Method This was a randomized, double-blind, crossover study of three doses of SLI381 (10, 20, and 30 mg), placebo, and an active control (Adderall ® 10 mg) given once daily to 51 children with ADHD. Weekly assessments in an analog classroom setting included blind ratings of attention and deportment and a performance measure (math test) obtained every 1.5 hours over a 12-hour period. Results SLI381 was well tolerated. All active treatment conditions displayed significant time course effects and were superior to placebo in improving efficacy measures. Dose-dependent improvements were evident for SLI381. SLI381 20 and 30 mg and Adderall all showed rapid improvements by 1.5 hours, but only the SLI381 20- and 30-mg doses showed continued activity at 10.5 and 12 hours for classroom behavior and math test performance versus placebo. Conclusions These data provide support for the benefit of this novel, once-daily amphetamine preparation in the treatment of ADHD. The longer duration of action of SLI381 has the potential to simplify psychostimulant dosing, thus reducing dose diversion and eliminating the need for in-school administration. SLI381 appears to be a useful treatment option for many children with ADHD.
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The use of a laboratory school protocol to evaluate concepts about efficacy and side effects of new formulations of stimulant medications.
Journal of Attention Disorders, 2002Co-Authors: James M. Swanson, Marc Lerner, Kelly Posner, Timothy Wigal, Kenneth Steinhoff, L. Greenhill, J. Freid, Sharon B. WigalAbstract:Recently, new long-acting formulations of racemic methylphenidate (MPH: Ritalin® LA, Metadate® CD and Concerta®) and amphetamine (AMP: Adderall XR®) were developed and are now approved by the Food ...
Sharon B. Wigal - One of the best experts on this subject based on the ideXlab platform.
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a pharmacokinetic pharmacodynamic study comparing a single morning dose of Adderall to twice daily dosing in children with adhd
Journal of the American Academy of Child and Adolescent Psychiatry, 2003Co-Authors: Laurence L. Greenhill, James M. Swanson, Sharon B. Wigal, Marc Lerner, Yuxin Zhang, Kelly Posner, Ken Steinhoff, Jane Fried, Susan B. Clausen, Simon J. TullochAbstract:Objective To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall®. Method Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l- amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. Results The pharmacokinetic profiles revealed similar morning concentrations of d - and l -amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition ( p Conclusions This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.
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Pharmacokinetics of SLI381 (Adderall XR), an extended-release formulation of Adderall.
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: James J. Mcgough, Sharon B. Wigal, Laurence L. Greenhill, Simon J. Tulloch, Thomas J. Spencer, Joseph Biederman, James T. Mccracken, Kelly Posner, Jeffrey Gornbein, James M. SwansonAbstract:ABSTRACT Objective To assess the pharmacokinetic (PK) properties of a single daily dose of Adderall ® (mixed amphetamine salts) and the extended-release formulation, SLI381 (Adderall XR™), in pediatric attention-deficit/hyperactivity disorder (ADHD). Method Fifty-one children (aged 6–12 years) with ADHD participated in a 6-week, seven-visit, PK and pharmacodynamic study. PK sampling occurred during visit 1 and again at visit 7. At visit 1, subjects received an initial oral dose of SLI381, 20 mg. At visit 7 subjects completed 1 week of medication treatment following random assignment to once-daily orally dosed SLI381 10 mg, 20 mg, or 30 mg; Adderall 10 mg; or placebo. Results PK parameters evidenced substantial intersubject variability (coefficients of variation=28–56%). Time to maximum concentration (T max ) for SLI381 versus Adderall showed average increases of 3.0 hours for dextroamphetamine ( t = −2.35, p = .04, df = 8.6) and 3.2 hours for levoamphetamine ( t = −2.39, p = .04, df = 9.2). The d - and l -isomer concentrations were highly correlated and approximated a 3:1 ratio. Conclusions SLI381 showed extended T max values compared with Adderall and appears suitable for once-daily dosing. Intersubject variability underscores the need for individual dose titration.
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A Pharmacokinetic/Pharmacodynamic Study Comparing a Single Morning Dose of Adderall to Twice-Daily Dosing in Children With ADHD
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: Laurence L. Greenhill, James M. Swanson, Sharon B. Wigal, Marc Lerner, Yuxin Zhang, Kelly Posner, Ken Steinhoff, Jane Fried, Susan B. Clausen, Simon J. TullochAbstract:Objective To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall®. Method Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l- amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. Results The pharmacokinetic profiles revealed similar morning concentrations of d - and l -amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition ( p Conclusions This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.
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Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD.
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: James T. Mccracken, James M. Swanson, Sharon B. Wigal, Laurence L. Greenhill, Thomas J. Spencer, Joseph Biederman, James J. Mcgough, Kelly Posner, Caroly Pataki, Yuxin ZhangAbstract:ABSTRACT Objectives This investigation was conducted primarily to assess the safety and efficacy of SLI381 (Adderall XR™), developed as a once-daily treatment for children with attention-deficit/hyperactivity disorder (ADHD). Secondary objectives included examination of the time course, pharmacokinetic, and pharmacodynamic properties of SLI381. Method This was a randomized, double-blind, crossover study of three doses of SLI381 (10, 20, and 30 mg), placebo, and an active control (Adderall ® 10 mg) given once daily to 51 children with ADHD. Weekly assessments in an analog classroom setting included blind ratings of attention and deportment and a performance measure (math test) obtained every 1.5 hours over a 12-hour period. Results SLI381 was well tolerated. All active treatment conditions displayed significant time course effects and were superior to placebo in improving efficacy measures. Dose-dependent improvements were evident for SLI381. SLI381 20 and 30 mg and Adderall all showed rapid improvements by 1.5 hours, but only the SLI381 20- and 30-mg doses showed continued activity at 10.5 and 12 hours for classroom behavior and math test performance versus placebo. Conclusions These data provide support for the benefit of this novel, once-daily amphetamine preparation in the treatment of ADHD. The longer duration of action of SLI381 has the potential to simplify psychostimulant dosing, thus reducing dose diversion and eliminating the need for in-school administration. SLI381 appears to be a useful treatment option for many children with ADHD.
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The use of a laboratory school protocol to evaluate concepts about efficacy and side effects of new formulations of stimulant medications.
Journal of Attention Disorders, 2002Co-Authors: James M. Swanson, Marc Lerner, Kelly Posner, Timothy Wigal, Kenneth Steinhoff, L. Greenhill, J. Freid, Sharon B. WigalAbstract:Recently, new long-acting formulations of racemic methylphenidate (MPH: Ritalin® LA, Metadate® CD and Concerta®) and amphetamine (AMP: Adderall XR®) were developed and are now approved by the Food ...
Simon J. Tulloch - One of the best experts on this subject based on the ideXlab platform.
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a pharmacokinetic pharmacodynamic study comparing a single morning dose of Adderall to twice daily dosing in children with adhd
Journal of the American Academy of Child and Adolescent Psychiatry, 2003Co-Authors: Laurence L. Greenhill, James M. Swanson, Sharon B. Wigal, Marc Lerner, Yuxin Zhang, Kelly Posner, Ken Steinhoff, Jane Fried, Susan B. Clausen, Simon J. TullochAbstract:Objective To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall®. Method Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l- amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. Results The pharmacokinetic profiles revealed similar morning concentrations of d - and l -amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition ( p Conclusions This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.
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Pharmacokinetics of SLI381 (Adderall XR), an extended-release formulation of Adderall.
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: James J. Mcgough, Sharon B. Wigal, Laurence L. Greenhill, Simon J. Tulloch, Thomas J. Spencer, Joseph Biederman, James T. Mccracken, Kelly Posner, Jeffrey Gornbein, James M. SwansonAbstract:ABSTRACT Objective To assess the pharmacokinetic (PK) properties of a single daily dose of Adderall ® (mixed amphetamine salts) and the extended-release formulation, SLI381 (Adderall XR™), in pediatric attention-deficit/hyperactivity disorder (ADHD). Method Fifty-one children (aged 6–12 years) with ADHD participated in a 6-week, seven-visit, PK and pharmacodynamic study. PK sampling occurred during visit 1 and again at visit 7. At visit 1, subjects received an initial oral dose of SLI381, 20 mg. At visit 7 subjects completed 1 week of medication treatment following random assignment to once-daily orally dosed SLI381 10 mg, 20 mg, or 30 mg; Adderall 10 mg; or placebo. Results PK parameters evidenced substantial intersubject variability (coefficients of variation=28–56%). Time to maximum concentration (T max ) for SLI381 versus Adderall showed average increases of 3.0 hours for dextroamphetamine ( t = −2.35, p = .04, df = 8.6) and 3.2 hours for levoamphetamine ( t = −2.39, p = .04, df = 9.2). The d - and l -isomer concentrations were highly correlated and approximated a 3:1 ratio. Conclusions SLI381 showed extended T max values compared with Adderall and appears suitable for once-daily dosing. Intersubject variability underscores the need for individual dose titration.
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A Pharmacokinetic/Pharmacodynamic Study Comparing a Single Morning Dose of Adderall to Twice-Daily Dosing in Children With ADHD
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: Laurence L. Greenhill, James M. Swanson, Sharon B. Wigal, Marc Lerner, Yuxin Zhang, Kelly Posner, Ken Steinhoff, Jane Fried, Susan B. Clausen, Simon J. TullochAbstract:Objective To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall®. Method Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l- amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. Results The pharmacokinetic profiles revealed similar morning concentrations of d - and l -amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition ( p Conclusions This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.
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sli381 Adderall xr a two component extended release formulation of mixed amphetamine salts bioavailability of three test formulations and comparison of fasted fed and sprinkled administration
Pharmacotherapy, 2002Co-Authors: Simon J. Tulloch, Yuxin Zhang, Angus M. Mclean, Kathleen N. Wolf, David A. MaysAbstract:Study Objectives. To assess the bioavailability of three test formulations of a single dose of extended-release Adderall 20-mg capsules compared with two doses of immediate-release Adderall 10-mg tablets, and to assess the bioequivalence of a single 30-mg dose of the chosen extended-release Adderall formulation (designated as SLI381) administered in applesauce (sprinkled) and the same dose administered as an intact capsule with or without food. Design. Randomized, open-label, crossover study. Setting. Clinical research unit. Patients. Forty-one healthy adults. Interventions. Study A had four treatment sequences: three test formulations (A, B, and C) of a single dose of extended-release Adderall 20 mg, and two 10-mg doses of Adderall given 4 hours apart. Study B had three treatment sequences: a single dose of SLI381 30 mg as an intact capsule after overnight fast, an intact capsule after a high-fat breakfast, and the contents of a capsule sprinkled in 1 tablespoon of applesauce. Measurements and Main Results. The 20-mg test formulation A had comparable pharmacokinetic profiles and bioequivalence in rate and extent of drug absorption to Adderall 10 mg twice/day for both d- and l-amphetamine. Formulations B and C had statistically significant differences from the reference drug in some pharmacokinetic parameters. A 30-mg dose of SLI381 showed no significant differences in rate and extent of absorption of d- and l-amphetamine for fasted or sprinkled conditions compared with the high-fat meal condition. Conclusion. SLI381 20 mg/day is bioequivalent to Adderall 10 mg twice/day. SLI381 30 mg administered in applesauce is bioequivalent in terms of both rate and extent of absorption to the same dose administered as an intact capsule in both fasted and fed states.
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SLI381 (Adderall XR), a Two‐Component, Extended‐Release Formulation of Mixed Amphetamine Salts: Bioavailability of Three Test Formulations and Comparison of Fasted, Fed, and Sprinkled Administration
Pharmacotherapy, 2002Co-Authors: Simon J. Tulloch, Yuxin Zhang, Angus M. Mclean, Kathleen N. Wolf, David A. MaysAbstract:Study Objectives. To assess the bioavailability of three test formulations of a single dose of extended-release Adderall 20-mg capsules compared with two doses of immediate-release Adderall 10-mg tablets, and to assess the bioequivalence of a single 30-mg dose of the chosen extended-release Adderall formulation (designated as SLI381) administered in applesauce (sprinkled) and the same dose administered as an intact capsule with or without food. Design. Randomized, open-label, crossover study. Setting. Clinical research unit. Patients. Forty-one healthy adults. Interventions. Study A had four treatment sequences: three test formulations (A, B, and C) of a single dose of extended-release Adderall 20 mg, and two 10-mg doses of Adderall given 4 hours apart. Study B had three treatment sequences: a single dose of SLI381 30 mg as an intact capsule after overnight fast, an intact capsule after a high-fat breakfast, and the contents of a capsule sprinkled in 1 tablespoon of applesauce. Measurements and Main Results. The 20-mg test formulation A had comparable pharmacokinetic profiles and bioequivalence in rate and extent of drug absorption to Adderall 10 mg twice/day for both d- and l-amphetamine. Formulations B and C had statistically significant differences from the reference drug in some pharmacokinetic parameters. A 30-mg dose of SLI381 showed no significant differences in rate and extent of absorption of d- and l-amphetamine for fasted or sprinkled conditions compared with the high-fat meal condition. Conclusion. SLI381 20 mg/day is bioequivalent to Adderall 10 mg twice/day. SLI381 30 mg administered in applesauce is bioequivalent in terms of both rate and extent of absorption to the same dose administered as an intact capsule in both fasted and fed states.
Yuxin Zhang - One of the best experts on this subject based on the ideXlab platform.
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a pharmacokinetic pharmacodynamic study comparing a single morning dose of Adderall to twice daily dosing in children with adhd
Journal of the American Academy of Child and Adolescent Psychiatry, 2003Co-Authors: Laurence L. Greenhill, James M. Swanson, Sharon B. Wigal, Marc Lerner, Yuxin Zhang, Kelly Posner, Ken Steinhoff, Jane Fried, Susan B. Clausen, Simon J. TullochAbstract:Objective To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall®. Method Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l- amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. Results The pharmacokinetic profiles revealed similar morning concentrations of d - and l -amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition ( p Conclusions This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.
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A Pharmacokinetic/Pharmacodynamic Study Comparing a Single Morning Dose of Adderall to Twice-Daily Dosing in Children With ADHD
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: Laurence L. Greenhill, James M. Swanson, Sharon B. Wigal, Marc Lerner, Yuxin Zhang, Kelly Posner, Ken Steinhoff, Jane Fried, Susan B. Clausen, Simon J. TullochAbstract:Objective To determine the pharmacokinetic and pharmacodynamic properties of once-daily versus twice-daily doses of Adderall®. Method Following a 1-week wash-out, 12 subjects with attention-deficit/hyperactivity disorder (ADHD) entered a double-blind crossover study comparing two conditions: QD (10 mg of Adderall at 7:30 a.m. and placebo at noon) or BID (10 mg of Adderall at 7:30 a.m. and at noon). At two sites, cohorts of six subjects each were assessed on two different days by a 12-hour laboratory school protocol. Plasma concentrations of d- and l- amphetamine, vital signs, teacher ratings of classroom behavior on the SKAMP, and 10-minute Math Test performance were measured repeatedly over 12 hours. An analysis of variance used center, subject-within-center, condition, and time-after-second-dose as independent variables. Results The pharmacokinetic profiles revealed similar morning concentrations of d - and l -amphetamine. However, concentrations were twice as high in the afternoon for BID as QD. The two conditions showed similar pharmacodynamic profiles in the morning, although improvement in math performance and behavior was maintained into the afternoon only in the BID condition ( p Conclusions This study suggests that twice-daily dosing of Adderall may be an effective strategy for afternoon control of attention and deportment for children with ADHD.
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Analog classroom assessment of a once-daily mixed amphetamine formulation, SLI381 (Adderall XR), in children with ADHD.
Journal of the American Academy of Child & Adolescent Psychiatry, 2003Co-Authors: James T. Mccracken, James M. Swanson, Sharon B. Wigal, Laurence L. Greenhill, Thomas J. Spencer, Joseph Biederman, James J. Mcgough, Kelly Posner, Caroly Pataki, Yuxin ZhangAbstract:ABSTRACT Objectives This investigation was conducted primarily to assess the safety and efficacy of SLI381 (Adderall XR™), developed as a once-daily treatment for children with attention-deficit/hyperactivity disorder (ADHD). Secondary objectives included examination of the time course, pharmacokinetic, and pharmacodynamic properties of SLI381. Method This was a randomized, double-blind, crossover study of three doses of SLI381 (10, 20, and 30 mg), placebo, and an active control (Adderall ® 10 mg) given once daily to 51 children with ADHD. Weekly assessments in an analog classroom setting included blind ratings of attention and deportment and a performance measure (math test) obtained every 1.5 hours over a 12-hour period. Results SLI381 was well tolerated. All active treatment conditions displayed significant time course effects and were superior to placebo in improving efficacy measures. Dose-dependent improvements were evident for SLI381. SLI381 20 and 30 mg and Adderall all showed rapid improvements by 1.5 hours, but only the SLI381 20- and 30-mg doses showed continued activity at 10.5 and 12 hours for classroom behavior and math test performance versus placebo. Conclusions These data provide support for the benefit of this novel, once-daily amphetamine preparation in the treatment of ADHD. The longer duration of action of SLI381 has the potential to simplify psychostimulant dosing, thus reducing dose diversion and eliminating the need for in-school administration. SLI381 appears to be a useful treatment option for many children with ADHD.
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sli381 Adderall xr a two component extended release formulation of mixed amphetamine salts bioavailability of three test formulations and comparison of fasted fed and sprinkled administration
Pharmacotherapy, 2002Co-Authors: Simon J. Tulloch, Yuxin Zhang, Angus M. Mclean, Kathleen N. Wolf, David A. MaysAbstract:Study Objectives. To assess the bioavailability of three test formulations of a single dose of extended-release Adderall 20-mg capsules compared with two doses of immediate-release Adderall 10-mg tablets, and to assess the bioequivalence of a single 30-mg dose of the chosen extended-release Adderall formulation (designated as SLI381) administered in applesauce (sprinkled) and the same dose administered as an intact capsule with or without food. Design. Randomized, open-label, crossover study. Setting. Clinical research unit. Patients. Forty-one healthy adults. Interventions. Study A had four treatment sequences: three test formulations (A, B, and C) of a single dose of extended-release Adderall 20 mg, and two 10-mg doses of Adderall given 4 hours apart. Study B had three treatment sequences: a single dose of SLI381 30 mg as an intact capsule after overnight fast, an intact capsule after a high-fat breakfast, and the contents of a capsule sprinkled in 1 tablespoon of applesauce. Measurements and Main Results. The 20-mg test formulation A had comparable pharmacokinetic profiles and bioequivalence in rate and extent of drug absorption to Adderall 10 mg twice/day for both d- and l-amphetamine. Formulations B and C had statistically significant differences from the reference drug in some pharmacokinetic parameters. A 30-mg dose of SLI381 showed no significant differences in rate and extent of absorption of d- and l-amphetamine for fasted or sprinkled conditions compared with the high-fat meal condition. Conclusion. SLI381 20 mg/day is bioequivalent to Adderall 10 mg twice/day. SLI381 30 mg administered in applesauce is bioequivalent in terms of both rate and extent of absorption to the same dose administered as an intact capsule in both fasted and fed states.
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SLI381 (Adderall XR), a Two‐Component, Extended‐Release Formulation of Mixed Amphetamine Salts: Bioavailability of Three Test Formulations and Comparison of Fasted, Fed, and Sprinkled Administration
Pharmacotherapy, 2002Co-Authors: Simon J. Tulloch, Yuxin Zhang, Angus M. Mclean, Kathleen N. Wolf, David A. MaysAbstract:Study Objectives. To assess the bioavailability of three test formulations of a single dose of extended-release Adderall 20-mg capsules compared with two doses of immediate-release Adderall 10-mg tablets, and to assess the bioequivalence of a single 30-mg dose of the chosen extended-release Adderall formulation (designated as SLI381) administered in applesauce (sprinkled) and the same dose administered as an intact capsule with or without food. Design. Randomized, open-label, crossover study. Setting. Clinical research unit. Patients. Forty-one healthy adults. Interventions. Study A had four treatment sequences: three test formulations (A, B, and C) of a single dose of extended-release Adderall 20 mg, and two 10-mg doses of Adderall given 4 hours apart. Study B had three treatment sequences: a single dose of SLI381 30 mg as an intact capsule after overnight fast, an intact capsule after a high-fat breakfast, and the contents of a capsule sprinkled in 1 tablespoon of applesauce. Measurements and Main Results. The 20-mg test formulation A had comparable pharmacokinetic profiles and bioequivalence in rate and extent of drug absorption to Adderall 10 mg twice/day for both d- and l-amphetamine. Formulations B and C had statistically significant differences from the reference drug in some pharmacokinetic parameters. A 30-mg dose of SLI381 showed no significant differences in rate and extent of absorption of d- and l-amphetamine for fasted or sprinkled conditions compared with the high-fat meal condition. Conclusion. SLI381 20 mg/day is bioequivalent to Adderall 10 mg twice/day. SLI381 30 mg administered in applesauce is bioequivalent in terms of both rate and extent of absorption to the same dose administered as an intact capsule in both fasted and fed states.
