Clinical trial NCT00152022: Efficacy and Safety of SPD465 in Adults With Moderately Symptomatic 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: 2005-09-09
Enrollment: 412
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 the participants sleep and how they perceive their quality of life.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of ADHD
* Baseline ADHD-RS-IV score \>= 32
* 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
* Females who are pregnant or lactating

Primary outcomes:
measure: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
timeFrame: Baseline (following ADHD medication washout of 7-28 days)
measure: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
timeFrame: Week 1
measure: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
timeFrame: Week 2
measure: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
timeFrame: Week 3
measure: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
timeFrame: Week 4
measure: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
timeFrame: Week 5
measure: The primary measure of efficacy will be the clinician-administered ADHD-rating scale (ADHD-RS-IV)
timeFrame: Week 6
Secondary outcomes:
measure: Clinical Global Impression of Improvement scale (CG(-I) - assessed at visits 1 through 6/Early Termination (ET)
timeFrame: Weeks 1, 2, 3, 4, 5, & 6
measure: Brown ADD Scale (BADDS) - completed at Baseline and 6/ET visits
timeFrame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6
measure: Adult ADHD Impact Module (AIM-A)-completed at Baseline and 6/ET visits.
timeFrame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6
measure: Pittsburgh Sleep Quality Index (PSQI) - taken at every visit from Baseline to study completion.
timeFrame: Baseline visit and weeks 1, 2, 3, 4, 5, & 6
Other outcomes:
Locations:
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Surman CB, Roth T. Impact of stimulant pharmacotherapy on sleep quality: post hoc analyses of 2 large, double-blind, randomized, placebo-controlled trials. J Clin Psychiatry. 2011 Jul;72(7):903-8. doi: 10.4088/JCP.11m06838.
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.