Evidence map›Paper›PMID 24106804›Full record

Trial reportBMC psychiatry2013

Self-Reported quality of life in adults with attention-deficit/hyperactivity disorder and executive function impairment treated with lisdexamfetamine dimesylate: a randomized, double-blind, multicenter, placebo-controlled, parallel-group study.

Lenard A Adler, Bryan Dirks, Patrick Deas, Aparna Raychaudhuri, Matthew Dauphin, Keith Saylor, Richard Weisler

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC psychiatry, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01101022 (A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-controlled, Parallel Group Study Evaluating the Safety and Efficacy of SPD489 on Executive Function), which is not on this map. Cited by 17 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01101022 phase4completednot on this map

A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-controlled, Parallel Group Study Evaluating the Safety and Efficacy of SPD489 on Executive Function (Self-Regulation) Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) Reporting Clinically Significant Impairment of Real-World Executive Function Behavior.

TypeinterventionalSponsorShireRan2010 to 2010Enrolled161ConditionsADHD Specifically With Executive Function ImpairmentArmsSPD489, Placebo
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Amphetamines for attention deficit hyperactivity disorder (ADHD) in adults.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
  7. Review
  8. Review
  9. Attention-deficit/hyperactivity disorder.Nature reviews. Disease primers · 2024
    Review
  10. Article
  11. Article
  12. Review
  13. Article
  14. A cost-effectiveness analysis of lisdexamfetamine dimesylate in the treatment of adults with attention-deficit/hyperactivity disorder in the UK.The European journal of health economics : HEPAC : health economics in prevention and care · 2018
    Article
  15. Review
  16. Review
  17. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Lenard A AdlerDepartment of Psychiatry and Child and Adolescent Psychiatry, New York University School of Medicine and Psychiatry Service, New York VA Harbor Healthcare System, New York, NY, USA. Lenard.Adler@nyumc.org.
Bryan Dirks
Patrick Deas
Aparna Raychaudhuri
Matthew Dauphin
Keith Saylor
Richard Weisler

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis study examined the effects of lisdexamfetamine dimesylate (LDX) on quality of life (QOL) in adults with attention-deficit/hyperactivity disorder (ADHD) and clinically significant executive function deficits (EFD).

methodsThis report highlights QOL findings from a 10-week randomized placebo-controlled trial of LDX (30-70 mg/d) in adults (18-55 years) with ADHD and EFD (Behavior Rating Inventory of EF-Adult, Global Executive Composite [BRIEF-A GEC] ≥65). The primary efficacy measure was the self-reported BRIEF-A; a key secondary measure was self-reported QOL on the Adult ADHD Impact Module (AIM-A). The clinician-completed ADHD Rating Scale version IV (ADHD-RS-IV) with adult prompts and Clinical Global Impressions-Severity (CGI-S) were also employed. The Adult ADHD QoL (AAQoL) was added while the study was in progress. A post hoc analysis examined the subgroup having evaluable results from both AIM-A and AAQoL.

resultsOf 161 randomized (placebo, 81; LDX, 80), 159 were included in the safety population. LDX improved AIM-A multi-item domain scores versus placebo; LS mean difference for Performance and Daily Functioning was 21.6 (ES, 0.93, P<.0001); Impact of Symptoms: Daily Interference was 14.9 (ES, 0.62, P<.0001); Impact of Symptoms: Bother/Concern was 13.5 (ES, 0.57, P=.0003); Relationships/Communication was 7.8 (ES, 0.31, P=.0302); Living With ADHD was 9.1 (ES, 0.79, P<.0001); and General Well-Being was 10.8 (ES, 0.70, P<.0001). AAQoL LS mean difference for total score was 21.0; for subscale: Life Productivity was 21.0; Psychological Health was 12.1; Life Outlook was 12.5; and Relationships was 7.3. In a post hoc analysis of participants with both AIM-A and AAQoL scores, AIM-A multi-item subgroup analysis scores numerically improved with LDX, with smaller difference for Impact of Symptoms: Daily Interference. The safety profile of LDX was consistent with amphetamine use in previous studies.

conclusionsOverall, adults with ADHD/EFD exhibited self-reported improvement on QOL, using the AIM-A and AAQoL scales in line with medium/large ES; these improvements were paralleled by improvements in EF and ADHD symptoms. The safety profile of LDX was similar to previous studies.

trial registrationClinicalTrials.gov, NCT01101022.

Indexed as

Activities of Daily LivingAdultAttentionAttention Deficit Disorder with HyperactivityCentral Nervous System StimulantsDextroamphetamineDose-Response Relationship, DrugDouble-Blind MethodExecutive FunctionFemaleHumansLisdexamfetamine DimesylateMaleNeuropsychological TestsQuality of LifeSelf ReportCentral Nervous System StimulantsDextroamphetamineLisdexamfetamine Dimesylate

Identifiers

PMID24106804
PMCPMC3854089

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.