Phase 3
Completed N=314
Efficacy and Safety of Lisdexamfetamine Dimesylate (LDX) in Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT00735371 ↗Enrolled (actual)
314
Serious AEs
0.0%
Results posted
Feb 2010
Primary outcomePrimary: Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks — -18.3; -21.1; -20.7; -12.8 Units on a scale — p=0.0056
Summary
The study will evaluate the efficacy of LDX treatment group compared to placebo on the change from Baseline ADHD-RS-IV score at endpoint.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale-fourth Edition (ADHD-RS-IV) Total Score at up to 4 Weeks |
-18.3; -21.1; -20.7; -12.8 | 0.0056 sig |
| SECONDARY Number of Participants With Improvement on Clinical Global Impression-Improvement (CGI-I) Scores |
44; 53; 57; 30 | 0.0235 sig |
| SECONDARY Youth Quality of Life-Research Version (YQOL-R) Total Score |
79.3; 80.5; 78.8; 79.2; 81.1; 81.3 | — |
Eligibility Criteria
Inclusion Criteria
- Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
- Baseline ADHD-RS-IV score >=28
- BP w/in 95th percentile for age, gender, and height
Exclusion Criteria
- Subject has controlled or uncontrolled comorbid psychiatric diagnosis
- Subject has conduct disorder
- Suicidal
- Under or overweight
- Concurrent chronic or acute illness that might confound results.
Data sourced from ClinicalTrials.gov (NCT00735371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.