Attention-deficit/hyperactivity disorder-specific quality of life with triple-bead mixed amphetamine salts (SPD465) in adults: results of a randomized, double-blind, placebo-controlled study.

Abstract

OBJECTIVE:

To assess the quality of life (QOL) in adults with attention-deficit/hyperactivity disorder (ADHD) given triple-bead mixed amphetamine salts (MAS), a long-acting amphetamine formulation designed for a duration of action of up to 16 hours.

METHOD:

274 adults with ADHD (DSM-IV-TR criteria) were randomly assigned to 7 weeks of double-blind treatment with an optimal dose of triple-bead MAS (12.5 mg to 75 mg) (N = 137) or placebo (N = 137). As a secondary objective of this study, QOL was assessed on the basis of self-reported Adult ADHD Impact Module (AIM-A) scores, describing ADHD-specific QOL in 6 domains and global QOL (questions 1-4). To assess safety, data were collected on adverse events, vital signs, electrocardiograms, laboratory tests, and sleep quality. The trial was conducted from January 2005 to June 2005.

RESULTS:

Statistically significant improvement between triple-bead MAS and placebo was observed in all 6 ADHD-specific AIM-A subscales. In addition, statistically significant improvement in global QOL between triple-bead MAS and placebo was seen, based on AIM-A question 1 (p = .0006) and question 4 (p = .0001). Patients' age, gender, race, and prior use of stimulant medication were not found to significantly affect AIM-A subscale scores. The most common treatment-emergent adverse events with triple-bead MAS (insomnia, dry mouth, decreased appetite, headache, and weight decreased) were consistent with amphetamine treatment, and their incidence generally decreased with time.

CONCLUSIONS:

Adults with ADHD showed significantly improved QOL for both ADHD-specific and global measures with triple-bead MAS in comparison to placebo, based on AIM-A scores. Treatment-emergent adverse events were mostly mild to moderate in intensity and were consistent with amphetamine treatment.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00150579.

• Authors: Thomas J Spencer, Jeanne M Landgraf, Lenard A Adler, Richard H Weisler, Colleen S Anderson, Sharon H Youcha
• Journal: The Journal of clinical psychiatry (J Clin Psychiatry) Vol. 69 Issue 11 Pg. 1766-75 (Nov 2008) ISSN: 1555-2101 [Electronic] United States
• PMID: 19026251 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2008 Physicians Postgraduate Press, Inc.

Chemical References

• Central Nervous System Stimulants
• Delayed-Action Preparations
• Amphetamine

Topics

• Adult
• Amphetamine (administration & dosage, adverse effects)
• Attention Deficit Disorder with Hyperactivity (drug therapy)
• Central Nervous System Stimulants (administration & dosage, adverse effects)
• Delayed-Action Preparations
• Double-Blind Method
• Female
• Humans
• Least-Squares Analysis
• Male
• Middle Aged
• Quality of Life