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Data from one of the largest placebo-controlled stimulant trials of adults with ADHD1-3

Largest Controlled Stimulant Trial of Adults with ADHD

Study design:

  • A Phase 3, double-blind, parallel-group, placebo-controlled trial with forced-dose escalation in 420 adult patients aged 18 to 55 years with ADHD

Arrows
Treatment Arm Week 1 Week 2 Week 3 Week 4
Placebo        
Vyvanse 30 mg/d Vyvanse 30 mg/d Vyvanse 30 mg/d Vyvanse 30 mg/d Vyvanse 30 mg/d
Vyvanse 50 mg/d Vyvanse 30 mg/d Vyvanse 50 mg/d Vyvanse 50 mg/d Vyvanse 50 mg/d
Vyvanse 70 mg/d Vyvanse 30 mg/d Vyvanse 50 mg/d Vyvanse 70 mg/d Vyvanse 70 mg/d

  • The primary efficacy measure was the clinician-administered ADHD Rating Scale (ADHD-RS) with adult prompts
  • Secondary objectives were to assess the dose response of Vyvanse as measured by ADHD-RS with adult prompts, and assessment based on CGI-I,* and to evaluate safety and sleep parameters†

Results

  • Significant improvements in ADHD symptoms were seen at Week 1 (P<.001) with Vyvanse and continued throughout the study period
  • CGI-I scores demonstrated that the percent of patients who were rated as “much improved” or “very much improved” was significantly higher with Vyvanse compared with placebo
  • The most common adverse events (≥10% and twice placebo) reported in this study for patients taking Vyvanse were decreased appetite, insomnia, and dry mouth.
    Misuse of amphetamine may cause sudden death and serious cardiovascular events

*CGI-I = Clinical Global Impressions-Improvement
†Assessment of sleep quality was based on Pittsburgh Sleep Quality Index (PSQI)

References

  1. MEDLINE Search: Clinical Trials Adult ADHD. Available at: http://www.ncbi.nlm.nih.gov/sites/entrez?cmd=&db=pubmed&orig_db=PubMed&term=Clinical%20Trials%20Adult%20ADHD. Accessed April 21, 2008.
  2. ADHD Clinical Trials Adult search. Available at: http://www.clinicaltrials.gov/ct2/results?cond=%22Attention+Deficit+Disorder+with+Hyperactivity%22.
    Accessed April 21, 2008.
  3. Adler LA, Goodman DW, Kollins SH, et al. Double-blind, placebo-controlled study of the efficacy and safety of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. J Clin Psychiatry. 2008;69:1364-1373.
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