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Physician perception of clinical improvement in children with attention-deficit/hyperactivity disorder: a post hoc comparison of lisdexamfetamine dimesylate and mixed amphetamine salts extended release in a crossover analog classroom study.

López FA, Scheckner B, Childress AC - Neuropsychiatr Dis Treat (2011)

Bottom Line: Of the 50 children who completed the study, 32% of LDX participants were very much improved vs 16% of MAS XR, and 2% of placebo participants relative to baseline.Analysis showed that LDX had a significantly higher number of children with a very much improved score on the CGI-I than MAS XR (P = 0.0386).Treatment of children with LDX resulted in a higher number of participants with a very much improved score on the CGI-I than treatment with MAS XR or placebo.

View Article: PubMed Central - PubMed

Affiliation: Children's Developmental Center, Winter Park, FL, USA;

ABSTRACT

Objective: To assess effects of lisdexamfetamine dimesylate (LDX) and mixed amphetamine salts extended release (MAS XR) on symptom improvement in children with attention-deficit/hyperactivity disorder (ADHD).

Methods: Post hoc analysis of a randomized, double-blind, placebo-controlled, crossover analog-classroom environment was conducted. The primary efficacy outcome was the deportment subscale of the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP-D) rating scale. The secondary efficacy outcome was the investigator-rated Clinical Global Impressions-Improvement (CGI-I), a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), which assesses improvement over time from baseline. McNemar test was used to compare participants' responses to LDX and MAS XR on CGI-I scores dichotomized into 1 (very much improved) vs all other response scores (2 to 7) in a 2 × 2 table.

Results: Fifty-two children (aged 6 to 12 years) were enrolled, titrated, and randomized; 50 completed the study. Investigators rated 74% of LDX participants as either very much improved or much improved on the CGI-I scale relative to 72% of MAS XR participants and 18% of placebo participants. Of the 50 children who completed the study, 32% of LDX participants were very much improved vs 16% of MAS XR, and 2% of placebo participants relative to baseline. McNemar test indicated that 10 participants were very much improved with LDX, but not MAS XR; 2 participants were very much improved with MAS XR, but not LDX; 6 participants were very much improved with both, while 32 were not very much improved with either. Analysis showed that LDX had a significantly higher number of children with a very much improved score on the CGI-I than MAS XR (P = 0.0386).

Conclusion: Treatment of children with LDX resulted in a higher number of participants with a very much improved score on the CGI-I than treatment with MAS XR or placebo.

No MeSH data available.


Related in: MedlinePlus

Schematic diagram of study design.aNotes: aParticipants were randomized according to a balanced 3 × 3 Latin-Square with 6 treatment sequences. In order to keep the balance of treatment sequences within each block, the identical block-randomization schedule was used for all three categories of the drug treatment (eg, MAS XR 10 mg/day, LDX 30 mg/day, and placebo; or MAS XR 20 mg/day, LDX 50 mg/day, and placebo; or MAS XR 40 mg/day, LDX 70 mg/day, and placebo).Abbreviations: LDX, lisdexamfetamine dimesylate; MAS XR, mixed amphetamine salts extended release.
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f1-ndt-7-267: Schematic diagram of study design.aNotes: aParticipants were randomized according to a balanced 3 × 3 Latin-Square with 6 treatment sequences. In order to keep the balance of treatment sequences within each block, the identical block-randomization schedule was used for all three categories of the drug treatment (eg, MAS XR 10 mg/day, LDX 30 mg/day, and placebo; or MAS XR 20 mg/day, LDX 50 mg/day, and placebo; or MAS XR 40 mg/day, LDX 70 mg/day, and placebo).Abbreviations: LDX, lisdexamfetamine dimesylate; MAS XR, mixed amphetamine salts extended release.

Mentions: Children aged 6 to 12 years with a primary diagnosis of ADHD of the combined or predominantly hyperactive-impulsive subtypes, as defined by DSM-IV-TR criteria, were eligible for enrollment in this randomized, double-blind, placebo-controlled, analog classroom study. The study design as illustrated in Figure 1 comprised 3 treatment periods: 1-week screening; 3-week open-label titration to optimal MAS XR dose (10, 20, or 30 mg/day); 3-week randomized, double-blind (ie, participants and investigators) treatment crossover periods with optimum dose of MAS XR, LDX dose approximately equivalent to the optimized MAS XR dose, and placebo. Final selection of optimal MAS XR dose and randomization to order of double-blind treatment sequence occurred during visit 5 along with practice analog classroom sessions. Blinding was ensured through use of matching capsule formulations and the delivery of prepackaged individual drug kits based on randomization numbers. No unblinding or breaking of treatment codes occurred during the study. Participants were evaluated in the laboratory school on the last day of each week of the double-blind period. All study activities were performed in accordance with the principles of the International Conference on Harmonisation Good Clinical Practice, 18th World Medical Assembly (Helsinki 1964), and amendments of the 29th (Tokyo 1975), the 35th (Venice 1983), the 41st (Hong Kong 1989), and the 48th (South Africa 1996) World Medical Assemblies.


Physician perception of clinical improvement in children with attention-deficit/hyperactivity disorder: a post hoc comparison of lisdexamfetamine dimesylate and mixed amphetamine salts extended release in a crossover analog classroom study.

López FA, Scheckner B, Childress AC - Neuropsychiatr Dis Treat (2011)

Schematic diagram of study design.aNotes: aParticipants were randomized according to a balanced 3 × 3 Latin-Square with 6 treatment sequences. In order to keep the balance of treatment sequences within each block, the identical block-randomization schedule was used for all three categories of the drug treatment (eg, MAS XR 10 mg/day, LDX 30 mg/day, and placebo; or MAS XR 20 mg/day, LDX 50 mg/day, and placebo; or MAS XR 40 mg/day, LDX 70 mg/day, and placebo).Abbreviations: LDX, lisdexamfetamine dimesylate; MAS XR, mixed amphetamine salts extended release.
© Copyright Policy
Related In: Results  -  Collection

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getmorefigures.php?uid=PMC3101887&req=5

f1-ndt-7-267: Schematic diagram of study design.aNotes: aParticipants were randomized according to a balanced 3 × 3 Latin-Square with 6 treatment sequences. In order to keep the balance of treatment sequences within each block, the identical block-randomization schedule was used for all three categories of the drug treatment (eg, MAS XR 10 mg/day, LDX 30 mg/day, and placebo; or MAS XR 20 mg/day, LDX 50 mg/day, and placebo; or MAS XR 40 mg/day, LDX 70 mg/day, and placebo).Abbreviations: LDX, lisdexamfetamine dimesylate; MAS XR, mixed amphetamine salts extended release.
Mentions: Children aged 6 to 12 years with a primary diagnosis of ADHD of the combined or predominantly hyperactive-impulsive subtypes, as defined by DSM-IV-TR criteria, were eligible for enrollment in this randomized, double-blind, placebo-controlled, analog classroom study. The study design as illustrated in Figure 1 comprised 3 treatment periods: 1-week screening; 3-week open-label titration to optimal MAS XR dose (10, 20, or 30 mg/day); 3-week randomized, double-blind (ie, participants and investigators) treatment crossover periods with optimum dose of MAS XR, LDX dose approximately equivalent to the optimized MAS XR dose, and placebo. Final selection of optimal MAS XR dose and randomization to order of double-blind treatment sequence occurred during visit 5 along with practice analog classroom sessions. Blinding was ensured through use of matching capsule formulations and the delivery of prepackaged individual drug kits based on randomization numbers. No unblinding or breaking of treatment codes occurred during the study. Participants were evaluated in the laboratory school on the last day of each week of the double-blind period. All study activities were performed in accordance with the principles of the International Conference on Harmonisation Good Clinical Practice, 18th World Medical Assembly (Helsinki 1964), and amendments of the 29th (Tokyo 1975), the 35th (Venice 1983), the 41st (Hong Kong 1989), and the 48th (South Africa 1996) World Medical Assemblies.

Bottom Line: Of the 50 children who completed the study, 32% of LDX participants were very much improved vs 16% of MAS XR, and 2% of placebo participants relative to baseline.Analysis showed that LDX had a significantly higher number of children with a very much improved score on the CGI-I than MAS XR (P = 0.0386).Treatment of children with LDX resulted in a higher number of participants with a very much improved score on the CGI-I than treatment with MAS XR or placebo.

View Article: PubMed Central - PubMed

Affiliation: Children's Developmental Center, Winter Park, FL, USA;

ABSTRACT

Objective: To assess effects of lisdexamfetamine dimesylate (LDX) and mixed amphetamine salts extended release (MAS XR) on symptom improvement in children with attention-deficit/hyperactivity disorder (ADHD).

Methods: Post hoc analysis of a randomized, double-blind, placebo-controlled, crossover analog-classroom environment was conducted. The primary efficacy outcome was the deportment subscale of the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP-D) rating scale. The secondary efficacy outcome was the investigator-rated Clinical Global Impressions-Improvement (CGI-I), a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), which assesses improvement over time from baseline. McNemar test was used to compare participants' responses to LDX and MAS XR on CGI-I scores dichotomized into 1 (very much improved) vs all other response scores (2 to 7) in a 2 × 2 table.

Results: Fifty-two children (aged 6 to 12 years) were enrolled, titrated, and randomized; 50 completed the study. Investigators rated 74% of LDX participants as either very much improved or much improved on the CGI-I scale relative to 72% of MAS XR participants and 18% of placebo participants. Of the 50 children who completed the study, 32% of LDX participants were very much improved vs 16% of MAS XR, and 2% of placebo participants relative to baseline. McNemar test indicated that 10 participants were very much improved with LDX, but not MAS XR; 2 participants were very much improved with MAS XR, but not LDX; 6 participants were very much improved with both, while 32 were not very much improved with either. Analysis showed that LDX had a significantly higher number of children with a very much improved score on the CGI-I than MAS XR (P = 0.0386).

Conclusion: Treatment of children with LDX resulted in a higher number of participants with a very much improved score on the CGI-I than treatment with MAS XR or placebo.

No MeSH data available.


Related in: MedlinePlus