1. POSTER 052
Double-Blind, Placebo-Controlled Efficacy and Safety Study
ABSTRACT of Lisdexamfetamine Dimesylate in Adolescents With Table 3. TEAEs Reported by ≥5% of Participants in Any Treatment Group, Safety Population (n=310)
TEAE LDX
Attention-Deficit/Hyperactivity Disorder
Background: Attention-deficit/hyperactivity disorder (ADHD), a neurobehavioral disorder that begins in childhood, is a (MedDRA Version 11.1), 30 mg/d 50 mg/d 70 mg/d All Doses Placebo
chronic condition that often persists into adolescence. The prevalence of ADHD worldwide is estimated to be approximately n (%) n=78 n=77 n=78 n=233 n=77
6.5% in school-aged children; estimates of prevalence range from approximately 3% to 10% in adolescents. Similar to
children with ADHD, adolescents may have inattention, impulsivity, and continue to exhibit functional impairments in Any TEAE 51 (65.4) 53 (68.8) 56 (71.8) 160 (68.7) 45 (58.4)
multiple life settings. However, adolescents may have decreased degrees of hyperactivity relative to younger children. Decreased appetite 29 (37.2) 21 (27.3) 29 (37.2) 79 (33.9) 2 (2.6)
For individuals with ADHD, psychostimulants are considered a first-line treatment. Long-duration stimulant preparations
for adolescents may be helpful, as they alleviate the need to take medications throughout the day and help maintain the
Robert L. Findling, MD1 (Sponsor); Ann C. Childress, MD2; Andrew J. Cutler, MD3; Dizziness 1 (1.3) 4 (5.2) 5 (6.4) 10 (4.3) 3 (3.9)
adolescent’s privacy by avoiding trips to the nurse’s office during the school day. Lisdexamfetamine dimesylate (LDX,
Vyvanse®, Shire US Inc.) is a long-acting prodrug stimulant indicated for ADHD in children (6-12 years) and in adults,
Maria Gasior, MD, PhD4 (Guest Presenter); Mohamed Hamdani, MS4; M. Celeste Ferreira-Cornwell, PhD4 Dry mouth 0 6 (7.8) 4 (5.1) 10 (4.3) 1 (1.3)
Fatigue 4 (5.1) 2 (2.6) 4 (5.1) 10 (4.3) 2 (2.6)
but not adolescents (13-17 years). LDX is endogenously converted to d-amphetamine. Placebo-controlled studies that
focus on adolescents with ADHD are limited, and no study has previously been conducted with LDX in adolescents. This
1
University Hospitals Case Medical Center, Case Western Reserve University, Cleveland, OH; 2Center for Psychiatry and Behavioral Medicine, Headache 9 (11.5) 13 (16.9) 12 (15.4) 34 (14.6) 10 (13.0)
study examined the efficacy and safety of LDX vs placebo in adolescents with ADHD. Las Vegas, NV; 3Florida Clinical Research Center, LLC, Bradenton, FL; 4Shire Development Inc., Wayne, PA Insomnia 7 (9.0) 8 (10.4) 11 (14.1) 26 (11.2) 3 (3.9)
Methods: Eligible participants (13-17 years) with at least moderately symptomatic ADHD (ADHD Rating Scale IV:
Clinician Version [ADHD-RS-IV] score ≥28) were randomized to placebo or LDX (30, 50, or 70 mg/d) with forced- Irritability 6 (7.7) 2 (2.6) 8 (10.3) 16 (6.9) 3 (3.9)
dose titration in a 4-week, double-blind study. Primary and secondary efficacy measures were the ADHD-RS-IV, Nasal congestion 1 (1.3) 0 5 (6.4) 6 (2.6) 1 (1.3)
Clinical Global Impressions-Improvement (CGI-I) scale, and Youth Quality of Life–Research Version (YQOL-R). Safety Safety Assessments Efficacy Nasopharyngitis 2 (2.6) 4 (5.2) 1 (1.3) 7 (3.0) 1 (1.3)
assessments included treatment-emergent adverse events (TEAEs), vital signs, laboratory findings, physical exam, and
electrocardiogram (ECG). • Medical history (including medication) assessed at screening • Placebo-adjusted ADHD-RS-IV total score LS mean (95% confidence interval [CI]) differences for LDX Nausea 1 (1.3) 3 (3.9) 5 (6.4) 9 (3.9) 2 (2.6)
• Physical examinations and laboratory evaluations conducted at screening and week 4 30, 50, and 70 mg/d at endpoint were -5.5 (-9.7, -1.3), -8.3 (-12.5, -4.1), and -7.9 (-12.1, -3.8), respectively (P≤.0056
Results: Overall, 314 participants were randomized, 309 included in efficacy analyses, and 49 withdrew (11 due to Upper respiratory tract infection 2 (2.6) 4 (5.2) 4 (5.1) 10 (4.3) 6 (7.8)
TEAEs). At endpoint, changes in ADHD-RS-IV total score were significantly greater for each LDX dose vs placebo; • Treatment-emergent AEs (TEAEs) evaluated at all weeks including follow-up for each) (Figure 2a)
least squares mean (SE) change from baseline was -18.3 (1.25), -21.1 (1.28), and -20.7 (1.25) for 30, 50, and 70 mg/d – TEAEs were coded using Medical Dictionary for Regulatory Activities (MedDRA, Version 11.1) • ADHD-RS-IV change scores at all weeks and endpoint are summarized in Figure 2b Vomiting 0 1 (1.3) 2 (2.6) 3 (1.3) 4 (5.2)
LDX, respectively, and -12.8 (1.25) for placebo (P<.006 vs placebo for each). Significant differences in ADHD-RS-IV – TEAEs referred to new or worsening events with onset after the first date of treatment, and no later than 3 days Weight decreased 3 (3.8) 7 (9.1) 12 (15.4) 22 (9.4) 0
total and both subscale scores relative to placebo were observed in each LDX group beginning at week 1 and at every following termination of treatment
subsequent week throughout the study (P≤.0307). The percentage of participants rated very much or much improved at • Vital signs: sitting systolic blood pressure (SBP), diastolic BP (DBP), and pulse measured at all weeks Figure 2a. Reduction in ADHD-RS-IV symptoms. • No deaths or serious AEs occurred during the study
endpoint as measured by CGI-I was significantly greater for LDX (all doses) than for placebo (69.1% vs 39.5% [P<.0001], • 12-lead ECG performed at screening and at all weeks • LDX treatment was associated with small mean increases in SBP, DBP, and pulse rate (Table 4)
respectively). LDX vs placebo did not show statistically significant changes from baseline at endpoint in YQOL-R total 54 • Numbers of participants who met outlier criteria for vital signs are presented in Table 5
score and domain scores. The most frequently reported LDX TEAEs (≥5%) included decreased appetite, headache, Statistical Analyses
45
ADHD-RS-IV Total Score
insomnia, weight decrease, and irritability. There were small mean increases in pulse and systolic and diastolic blood • Efficacy was assessed for the full analysis set (FAS), which included all participants who took at least 1 randomized Baseline, Table 4. Summary of Vital Signs: Mean (SE) at Baseline and Change From Baseline at Endpoint,
pressure with LDX. There were no clinically meaningful trends in laboratory or ECG measurements noted with LDX. dose of study medication during this study and had a valid baseline and at least 1 postbaseline follow-up assessment 36
mean (SD) Safety Population (n=310)
Conclusions: LDX treatment (30, 50, 70 mg/d) was effective vs placebo as measured by change from baseline at of the primary outcome measure (ADHD-RS-IV total score) 27 n=78 n=76 n=78 n=77
endpoint in the ADHD-RS-IV total score. Efficacy of LDX vs placebo was demonstrated beginning at week 1 and • The safety population included participants who took at least 1 randomized dose of study medication during the study 18 Endpoint, Variable, Mean (SE)
continuing to the week-4 endpoint on ADHD-RS-IV total and subscale scores. More LDX participants were rated as mean (SD)
• Primary efficacy and secondary analyses performed on assessments using an analysis of covariance model 9 SBP (mm Hg) DBP (mm Hg) Pulse Rate (bpm)
improved vs placebo by the CGI-I, at every study week and endpoint. LDX demonstrated a safety profile consistent with • Differences between dichotomized groups based on CGI-I ratings analyzed by Cochran-Mantel-Haenszel test of n=76 n=72 n=75 n=76 Change,
previous LDX studies in children or adults. 0 Baseline Change Baseline Change Baseline Change
difference in raw mean scores LS mean (SE)
-9 30 mg/d (n=78) 114.7 (1.14) -0.8 (1.22) 68.0 (0.96) -0.5 (1.05) 73.3 (1.10) 5.0 (1.18)
INTRODUCTION ReSULTS
-18
-27 * * *
LDX 50 mg/d (n=77) 113.3 (1.17) 0.3 (1.01) 68.4 (0.71) 0.4 (0.84) 72.5 (1.24) 3.8 (1.37)
70 mg/d (n=78) 111.2 (1.20) 1.7 (1.21) 65.7 (0.69) 3.4 (0.80) 74.2 (1.07) 5.4 (1.27)
• stimates of the prevalence of attention-deficit/hyperactivity disorder (ADHD) in adolescents range from 3% to 10%
E -36 30 mg/d 50 mg/d 70 mg/d Placebo
in the US and worldwide1,2 Participant Disposition Placebo (n=77) 110.9 (1.17) 2.2 (1.04) 66.0 (0.85) 0.5 (0.97) 72.2 (1.28) 0.8 (1.36)
LDX
• Studies have indicated that 30% to 80% of children with ADHD will exhibit symptoms into adolescence and up to 65% • Of 314 participants enrolled and randomized, 309 were included in the FAS; 310 received at least 1 dose of study
will exhibit symptoms into adulthood3 medication and were included in the safety population (Figure 1) Table 5. Vital Sign Outliers by Defined Criteria at Endpoint in the Safety Population (n=310)
• Adolescents with ADHD: • 11 participants discontinued due to TEAEs, 10 participants due to lack of efficacy, and 5 participants due to
– Exhibit impaired family/peer relationships4 screening/baseline ECG abnormalities
Figure 2b. ADHD-RS-IV change from baseline. LDX
Endpoint
– Reported higher rates of traffic violations/accidents vs community-control participants5 (Primary 30 mg/d 50 mg/d 70 mg/d Placebo
– May have decreased hyperactivity vs younger children with ADHD, but still have inattention, impulsiveness, and Week 1 Week 2 Week 3 Week 4 Efficacy Result) n=78 n=77 n=78 n=77
inner restlessness6 Figure 1. N=314 0 Overall On-Therapy at Endpoint n=76 n=72 n=75 n=76
Change in ADHD-RS-IV Total Score
Enrolled
• Short- and long-acting stimulants are common ADHD treatments (for all ages) and have been shown to improve symptoms7,8 Participant LDX (30 mg/d)
SBP, n (%)
– Limited information on efficacy and safety in a large population of adolescents with ADHD is available, especially
placebo-controlled trials
disposition. Randomized 30 mg/d 50 mg/d 70 mg/d
-5 ≥120 mm Hg 23 (30.3) 20 (27.8) 20 (26.7) 19 (25.0)
(n=314) LDX LDX LDX Placebo ≥120 mm Hg + increase from baseline of ≥10 mm Hg 6 (7.9) 5 (6.9) 5 (6.7) 5 (6.6)
• Lisdexamfetamine dimesylate (LDX) is a long-acting prodrug stimulant for ADHD approved for treatment of children n=79 LDX (50 mg/d)
n=78 n=79 n=78 ≥130 mm Hg at 2 consecutive weeks
LS Mean (SE)
(aged 6 to 12 years), adolescents (aged 13 to 17 years), and adults (aged 18 to 55 years) 2 (2.6) 2 (2.8) 3 (4.0) 2 (2.6)
-10
– LDX is endogenously converted to d-amphetamine9 LDX (70 mg/d) ≥130 mm Hg + increase from baseline of ≥10 mm Hg 2 (2.6) 1 (1.4) 0 0
-2* -2* at 2 consecutive weeks
– LDX has shown efficacy and safety in large, short-term, placebo-controlled studies and long-term, open-label, Safety population n=78 n=77 n=78 n=77 ** ** **
follow-up studies in children and adults10-13 (n=310) (100.0%) (97.5%) (100.0%) (97.5%) -15 Placebo DBP,* n (%)
** ≥80 mm Hg 0 7 (9.7) 5 (6.7) 4 (5.3)
OBjeCTIveS FAS
(n=309)
n=78
(100.0%)
-1**
n=76
(96.2%)
n=78
(100.0%)
n=77
(97.5%)
-20 ** ** ** *
≥80 mm Hg + increase from baseline of ≥10 mm Hg 0 3 (4.2) 4 (5.3) 2 (2.6)
** ** Pulse rate,** n (%)
• The objectives of this clinical trial were to evaluate the acute efficacy and safety of LDX compared with placebo in an ** ** ** * * ≥100 bpm 4 (5.3) 1 (1.4) 3 (4.0) 1 (1.3)
adolescent population (aged 13 to 17 years) diagnosed with at least moderately symptomatic ADHD Discontinued n=15 n=13 n=11 n=10 -25
(n=49) (19.2%) (16.5%) (14.1%) (12.7%) ≥100 bpm + increase from baseline of ≥15 bpm 3 (3.9) 1 (1.4) 3 (4.0) 1 (1.3)
MeTHODS
* Participants who were not dosed: 1 LDX (50 mg/d) participant was lost to follow-up; 1 LDX (50 mg/d) participant refused further *No participants met DBP outlier criteria of ≥90 mm Hg at 2 consecutive weeks, with or without an additional increase from baseline of
participation; 1 placebo participant was lost to follow-up; and 1 placebo participant was lost because of protocol nonadherence/ ≥10 mm Hg across all treatment groups; **No participants met pulse outlier criteria of ≥110 bpm or ≥120 bpm (at 2 consecutive weeks
participant noncompliance. FAS, n=309.
A greater negative change in ADHD-RS-IV total score indicates an improvement. each), with or without an additional increase from baseline of ≥10 bpm.
** Participant who did not have a postbaseline ADHD-RS-IV assessment and was excluded from the FAS.
Study Design * LS mean (SE) change from baseline for LDX was significant vs placebo differences at endpoint (primary endpoint; P≤.0056). • Mean change in heart rate at endpoint from baseline ranged from approximately 2.0 to 3.1 bpm for all 3 doses of LDX
• A randomized, double-blind, multicenter, parallel-group, placebo-controlled, forced dose-titration efficacy and safety study
** LS mean (SE) change from baseline for LDX was significant vs placebo differences at all weeks with all 3 LDX doses (P≤.0076). vs 1.1 bpm for placebo
• Adolescents (aged 13 to 17 years) with ADHD randomized (1:1:1:1 ratio) to LDX (30, 50, or 70 mg/d) or placebo Demographic and Baseline Characteristics For the 50 mg/d and 70 mg/d dose groups, at week 1, participants were taking a 30 mg/d dose; for the 70 mg/d dose group, at
week 2, participants were taking a 50 mg/d dose. • The mean increase in QTcF interval at endpoint ranged from 0.2 to 2.7 msec for all 3 LDX doses vs 2.8 msec
– A double-blind stepwise forced dose-titration from 30 to 70 mg/d (3 weeks), followed by a dose-maintenance phase for placebo
(1 week) Table 1. Demographic and Baseline Characteristics, Safety Population (n=310)
• No participants had a QTcF interval ≥480 msec
– Study visits were scheduled weekly (7±2 days) and safety follow-up at 7 days (+2 additional days) LDX • There was significant improvement from baseline in LS mean (SE) ADHD-RS-IV inattention and hyperactivity/
• Three participants had a ≥60 msec change from baseline in QTcF interval; for these 3 participants, absolute values
• 4 phases: screening and washout, baseline, 4-week double-blind evaluation of treatment groups, and posttreatment (All doses) Placebo Overall impulsivity subscale scores (P≤.0307, P≤.0240, respectively) with LDX at all weeks assessed, including endpoint, vs
of QTcF interval were <480 msec
safety follow-up n=233 n=77 n=310 placebo (data not shown)
• Postbaseline ECGs deemed to be clinically significant occurred in 1 participant taking LDX
• At conclusion, eligible participants could take part in an open-label flexible-dose extension study – lacebo-adjusted LS means (95% CI differences) for both subscales at endpoint for the 30, 50, and 70 mg/d groups
P
Age (y), mean (SD) 14.6 (1.33) 14.5 (1.25) 14.6 (1.31) – This participant receiving LDX discontinued due to QTcF of 479 msec at week 2 (after 11 days’ exposure)
were significant (P≤.0109 for each)
Key Inclusion Criteria Age group, n (%) • Percentage of participants rated very much or much improved as measured by CGI-I was significantly greater for – QTcF was 383.2 msec 3 days after LDX was discontinued
• Males or nonpregnant females (aged 13 to 17 years) who met Diagnostic and Statistical Manual of Mental Disorders, 13-14 y 122 (52.4) 41 (53.2) 163 (52.6) LDX (all doses) vs placebo at endpoint (69.1% vs 39.5% [P<.0001], respectively), and at every study week (4 weeks; • Overall, no clinically meaningful trends were observed in ECG interval data
Fourth Edition, Text Revision (DSM-IV-TR) criteria for ADHD diagnosis (any subtype) 15-17 y 111 (47.6) 36 (46.8) 147 (47.4) P<.0001 for each)
• Baseline ADHD Rating Scale IV: Clinician Version (ADHD-RS-IV) score of ≥28
Key Exclusion Criteria
Sex, n (%)
Male 165 (70.8) 53 (68.8) 218 (70.3)
• LDX vs placebo did not appear to have statistically significant changes from baseline in the YQOL-R total score or in
the self, relationship, environment, or general QOL domain scores (Table 2)
CONCLUSIONS
• Any significant comorbid psychiatric diagnosis Female 68 (29.2) 24 (31.2) 92 (29.7) • LDX treatment (30, 50, and 70 mg/d) was effective vs placebo as measured by the change from baseline to endpoint
– Oppositional defiant disorder was not exclusionary Ethnicity, n (%) Table 2. YQOL-R Total and Perceptual Domain Scores in the FAS (n=309), Mean (SD)* in the ADHD-RS-IV total score
• Any concurrent or prior illness/condition that might have compromised participant health, safety, or study measurements Hispanic/Latino 33 (14.2) 13 (16.9) 46 (14.8) • Efficacy of LDX was demonstrated beginning at week 1 and continuing to week 4 on the ADHD-RS-IV total and
• Any clinically significant abnormality in vital signs, electrocardiogram (ECG), or clinical laboratory test results Not Hispanic/Latino 200 (85.8) 64 (83.1) 264 (85.2) LDX both the inattention and hyperactivity/impulsivity subscale scores
• Use of medications with effects on the central nervous system or performance Race, n (%) • More LDX participants were rated as improved compared with placebo participants as measured by the CGI-I at every
30 mg/d 50 mg/d 70 mg/d Placebo study week and endpoint
Efficacy Measures White 179 (76.8) 66 (85.7) 245 (79.0)
Black/African American 37 (15.9) 9 (11.7) 46 (14.8) Baseline Endpoint Baseline Endpoint Baseline Endpoint Baseline Endpoint • The YQOL-R administered at baseline and week 4 indicated no change in the total and domain scores at week 4
• Primary outcome measure was the clinician-administered ADHD-RS-IV
Native Hawaiian/Other Pacific Islander 1 (0.4) 0 1 (0.3) – The relatively brief treatment period may have been too short to detect separation of treatment condition from
– The primary efficacy measurement was the change from baseline in ADHD-RS-IV total score at endpoint. 79.3 81.1 80.5 81.3 78.8 81.3 79.2 81.3
Asian 1 (0.4) 0 1 (0.3) Total Score placebo in adolescent QOL
Endpoint was the last postrandomization treatment week (ie, weeks 1 through 4) for which a valid ADHD-RS-IV (10.03) (11.09) (10.63) (11.86) (15.38) (14.66) (11.08) (12.16)
score was obtained American Indian/Alaska Native 1 (0.4) 0 1 (0.3) – YQOL-R was designed as a general application to assess the effectiveness of interventions for adolescents with
Other 14 (6.0) 2 (2.6) 16 (5.2) Self 68.3 71.8 69.2 72.1 67.9 72.2 67.2 71.2 physical/other disabilities; it may not address ADHD-specific aspects of QOL
– 18 items: reflect current symptoms of ADHD (based on DSM-IV-TR criteria) (10.18) (8.55) (9.52) (10.54) (13.89) (10.91) (11.48) (11.18)
• Secondary efficacy assessments Height (in), mean (SD) 66.1 (3.65) 65.7 (3.98) 66.0 (3.74) • LDX demonstrated a safety profile consistent with previous LDX studies in children and adults
Domain Scores
– Clinical Global Impressions (CGI) scale Relationship 80.1 82.2 81.7 82.8 79.9 82.1 80.5 81.4
Weight (lb), mean (SD) 141.3 (29.24) 137.5 (29.43) 140.4 (29.28)
• GI-Improvement (CGI-I): key secondary assessment that evaluated symptom improvement postrandomization
C
(weeks 1 to 4)
Body mass index (kg/m2), mean (SD) 22.6 (3.44) 22.3 (3.63) 22.5 (3.49)
(12.91)
81.6
(14.05)
83.6
(12.29)
83.3
(12.59)
83.4
(18.21)
81.2
(17.26)
84.5
(12.67)
83.6
(15.24)
85.6
RefeReNCeS
Environment
– 7-point scale: very much improved to very much worse ADHD subtype, n (%) (12.83) (15.02) (12.46) (13.78) (16.05) (15.15) (11.16) (12.04) 1. Centers for Disease Control and Prevention. MMWR Morb Mortal Wkly Rep. 2005;54:842-847.
Predominantly inattention 82 (35.2) 23 (29.9) 105 (33.9) 2. Polanczyk G, de Lima MS, Horta BL, Biederman J, Rohde LA. Am J Psychiatry. 2007;164:942-948.
– Dichotomized categories General 87.3 86.6 87.8 86.9 86.3 86.6 85.4 87.1 3. Dulcan M, and the Work Group on Quality Issues. J Am Acad Child Adolesc Psychiatry. 1997;36(10 suppl):85S-121S.
• mproved: 1 (very much improved) and 2 (much improved)
I Predominantly hyperactive-impulsive 2 (0.9) 0 2 (0.6) QOL (13.20) (15.18) (16.35) (16.06) (19.31) (20.16) (17.17) (16.06) 4. Reiff MI, Stein MT. Pediatr Clin North Am. 2003;50:1019-1048.
• ot improved: 3 to 7 (all other categories)
N Combined 149 (63.9) 54 (70.1) 203 (65.5) 5. Barkley RA. Psychiatr Clin North Am. 2004;27:233-260.
*YQOL-R scores are on a 0-100 scale with higher scores indicating better perceived QOL.
ADHD-RS-IV total score at baseline, mean (SD) 37.6 (6.80) 38.5 (7.11) 37.8 (6.88) 6. Harpin VA. Arch Dis Child. 2005;90(suppl 1):i2-i7.
• GI-Severity (CGI-S): assessed global participant symptom severity at baseline
C All P values were not significant. 7. Arnsten AFT. Neuropsychopharmacology. 2006;31:2376-2383.
– 7-point scale: normal to extremely ill Baseline CGI-S rating, n (%) 8. Biederman J, Spencer T, Wilens T. Int J Neuropsychopharmacol. 2004;7:77-97.
– ADHD-RS-IV weekly total and subscale scores Mildly ill 2 (0.9) 0 2 (0.6) Safety 9. Pennick M. Neuropsychiatr Dis Treat. 2010;6:317-327.
• he ADHD-RS-IV total score composed of 2 subscales
T Moderately ill 126 (54.1) 42 (54.5) 168 (54.2) • The most frequently occurring (≥5%) TEAEs are summarized in Table 3 10. Biederman J, Krishnan S, Zhang Y, McGough JJ, Findling RL. Clin Ther. 2007;29:450-463.
127 (41.0) 11. Findling RL, Childress AC, Krishnan S, McGough JJ. CNS Spectr. 2008;13:614-620.
– Inattention (odd numbered items 1 to 17) Markedly ill 95 (40.8) 32 (41.6) • TEAEs in all LDX and placebo groups were generally mild/moderate in intensity 12. Adler LA, Goodman DW, Kollins SH, et al. J Clin Psychiatry. 2008;69:1364-1373.
– Hyperactivity/impulsivity (even numbered items 2 to 18) Severely ill 10 (4.3) 2 (2.6) 12 (3.9) • 6 participants (4 receiving LDX and 2 receiving placebo) had severe TEAEs 13. Weisler R, Young J, Mattingly G, Gao J, Squires L, Adler L. CNS Spectr. 2009;14:573-585.
– Youth Quality of Life–Research Version (YQOL-R) scale Extremely ill 0 1 (1.3) 1 (0.3) – All severe LDX TEAEs were deemed treatment-related (except headache)
• ssessed participant perception of QOL at baseline and week 4
A Dr Findling receives or has received research support, acted as a consultant and/or served on a speaker’s bureau for Abbott, Addrenex, AstraZeneca, Biovail,
– The 4 LDX participants had 6 severe TEAEs (decreased appetite [1], headache [1], insomnia [2], irritability [1], Bristol-Myers Squibb, Forest, GlaxoSmithKline, Johnson & Johnson, KemPharm Lilly, Lundbeck, Neuropharm, Novartis, Noven, Organon, Otsuka, Pfizer,
• Participant-completed, 56-item instrument validated in non-ADHD populations • The mean (SD) CGI-S scores at baseline were 4.5 (0.55), 4.5 (0.62), and 4.5 (0.60) for the 30, 50, and 70 mg/d LDX mood swings [1]) Rhodes Pharmaceuticals, Sanofi-Aventis, Schering-Plough, Seaside Therapeutics, Sepracor, Shire, Solvay, Supernus Pharmaceuticals, Validus, and Wyeth.
• aw scores transformed to a 0- to 100-point scale, higher scores indicating better QOL
R groups, respectively, and 4.5 (0.62) for the placebo group
– The 2 placebo participants had 3 severe TEAEs (agitation, irritability, stomach discomfort) Dr Childress receives or has received grant/research support, acted as a consultant and/or speaker for Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Johnson
& Johnson Pharmaceutical Research & Development, LLC, Lilly USA, NextWave, and Novartis, Ortho-McNeil Janssen Scientific Affairs, LLC, Sepracor, Shire,
and Somerset. Dr Cutler receives or has received research support, acted as a consultant and/or speaker, and participated in a CME advisory board for
Abbott, Addrenex, AstraZeneca, Bristol-Myers Squibb, Cephalon, GlaxoSmithKline, Janssen, Jazz Pharmaceuticals, Johnson & Johnson PRD, Lilly, McNeil
Pharmaceuticals, Memory Pharmaceuticals, Merck, Neuroscience Education Institute, Novartis, Ortho-McNeil, Otsuka, Pfizer, Sanofi (including Sanofi-
Synthelabo, Sanofi-Aventis), Sepracor, Shire, Shionogi, Solvay, Supernus, and Targacept. Dr Gasior is an employee of Shire and holds stock and/or stock
Under the direction of the authors, Huda I. Abdullah, PhD, and Michael Pucci, PhD, employees of Ogilvy CommonHealth Scientific options in Shire. Mr Hamdani is an employee of Shire and holds stock and/or stock options in Shire. Dr Ferreira-Cornwell is an employee of Shire and holds
Clinical research was funded by the sponsor, Shire Development Inc. Communications (OCHSC), provided writing assistance for this poster. Editorial assistance in formatting, proofreading, copy editing,
and fact checking was also provided by OCHSC. Shire Development Inc. provided funding to OCHSC for support in writing and
stock and/or stock options in Shire.
editing this poster. Presented at the 49th Annual Meeting of American College of Neuropsychopharmacology. December 5-9, 2010; Miami Beach, FL.