NCT00150579

Efficacy and Safety of SPD465 in Adults With ADHD

Completed Phase 3 Last updated 30 June 2021

What this trial tests

Phase 3 trial testing Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate in Attention Deficit Disorder With Hyperactivity in 240 participants. Completed in 14 June 2005.

Timeline

27 January 2005

Primary endpoint
14 June 2005

14 June 2005

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	240
Start date	27 January 2005
Primary completion	14 June 2005
Estimated completion	14 June 2005

Drugs / interventions tested

• Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate

Conditions studied

• Attention Deficit Disorder With Hyperactivity — all drugs for Attention Deficit Disorder With Hyperactivity →

Sponsor

Shire — full company profile →

Who can join

Adults 18 to 55, any sex, with Attention Deficit Disorder With Hyperactivity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to assess the safety and effectiveness of SPD465 compared to placebo (a capsule with no medication in it) in the treatment of ADHD. The study will also look at how SPD465 affects sleep and how the participants perceive their quality of life.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Amphetamines for attention deficit hyperactivity disorder (ADHD) in adults.
   Castells X, Blanco-Silvente L, Cunill R. · · 2018 · cited 66× · PMID 30091808 · DOI 10.1002/14651858.cd007813.pub3
2. 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.
   Spencer TJ, Landgraf JM, Adler LA, Weisler RH, et al · · 2008 · cited 26× · PMID 19026251 · DOI 10.4088/jcp.v69n1112
3. Improved Executive Function in Adults Diagnosed With Attention-Deficit/ Hyperactivity Disorder as Measured by the Brown Attention-Deficit Disorder Scale Following Treatment With SHP465 Mixed Amphetamine Salts Extended-Release: Post Hoc Analyses From 2 Randomized, Placebo-Controll
   Brown TE, Chen J, Robertson B. · · 2022 · cited 8× · PMID 33150816 · DOI 10.1177/1087054720961819
4. ADHD-KG: a knowledge graph of attention deficit hyperactivity disorder.
   Papadakis E, Baryannis G, Batsakis S, Adamou M, et al · · 2023 · cited 3× · PMID 38028962 · DOI 10.1007/s13755-023-00253-8
5. <i>Post hoc</i> Responder and Remission Analyses from Two Studies of SHP465 Mixed Amphetamine Salts Extended-Release Among Adults with Attention-Deficit/Hyperactivity Disorder.
   Adler LA, Robertson B, Chen J, Sarkis E. · · 2020 · cited 2× · PMID 32423239 · DOI 10.1089/cap.2020.0012
6. Post-Hoc Analyses of the Effects of Baseline Sleep Quality on SHP465 Mixed Amphetamine Salts Extended-Release Treatment Response in Adults with Attention-Deficit/Hyperactivity Disorder.
   Surman CBH, Robertson B, Chen J, Cortese S. · · 2019 · cited 2× · PMID 31228031 · DOI 10.1007/s40263-019-00645-z
7. A simple formula for enumerating comparisons in trials and network meta-analysis.
   Shokraneh F, Adams CE. · · 2019 · cited 2× · PMID 30863537 · DOI 10.12688/f1000research.17352.2
8. Psychiatric Briefs
   · 2009