Clinical trial NCT00150579: Efficacy and Safety of SPD465 in Adults With ADHD
Official title: A Phase III, Randomized, Double-blind, Multi-center, Placebo-Controlled, Parallel-Group, Safety and Efficacy Study of SPD465 in Adults With Attention-Deficit Hyperactivity Disorder (ADHD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Attention Deficit Disorder With Hyperactivity
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of ADHD
* Baseline ADHD-RS-IV score \>= 24
* Non-pregnant females of childbearing potential must comply with contraceptive restrictions

Exclusion Criteria:

* Significantly underweight or morbidly obese
* Comorbid psychiatric diagnosis with significant symptoms such as Axis II disorders or severe Axis I disorders
* History of seizure, tic disorder, or a current diagnosis and/or family history of Tourette's Disorder

Primary outcomes:
measure: Change from Baseline in the ADHD-rating scale 4th Edition (ADHD-RS-IV) total score to the Endpoint assessment.
timeFrame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
Secondary outcomes:
measure: Change from Baseline in the Clinical Global Impression of Improvement scale (CGI-I) to the Endpoint assessment.
timeFrame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
measure: Change from Baseline in the Time-Sensitive ADHD Symptom Scale (TASS) score to the Endpoint assessment.
timeFrame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
measure: Change from Baseline in the Brown Attention Deficit Disorder Scale (BADDS) to the Endpoint assessment
timeFrame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
measure: Change in Baseline in the Adult ADHD Impact Module (AIM-A) score to the Endpoint assessment
timeFrame: Baseline, and the Endpoint (average of weeks 5, 6, 7).
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 1
timeFrame: Baseline and Week 1.
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 4
timeFrame: Baseline and Week 4.
measure: Change from Baseline in Pittsburgh Sleep Quality Index (PSQI) at Week 7
timeFrame: Baseline and Week 7.
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Surman CBH, Robertson B, Chen J, Cortese S. 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. CNS Drugs. 2019 Jul;33(7):695-706. doi: 10.1007/s40263-019-00645-z.
citation: Brown TE, Landgraf JM. Improvements in executive function correlate with enhanced performance and functioning and health-related quality of life: evidence from 2 large, double-blind, randomized, placebo-controlled trials in ADHD. Postgrad Med. 2010 Sep;122(5):42-51. doi: 10.3810/pgm.2010.09.2200.
citation: Spencer TJ, Landgraf JM, Adler LA, Weisler RH, Anderson CS, Youcha SH. 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. J Clin Psychiatry. 2008 Nov;69(11):1766-75. doi: 10.4088/jcp.v69n1112. Epub 2008 Nov 4.
citation: Spencer TJ, Adler LA, Weisler RH, Youcha SH. Triple-bead mixed amphetamine salts (SPD465), a novel, enhanced extended-release amphetamine formulation for the treatment of adults with ADHD: a randomized, double-blind, multicenter, placebo-controlled study. J Clin Psychiatry. 2008 Sep;69(9):1437-48. doi: 10.4088/jcp.v69n0911. Epub 2008 Sep 9.