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.

Shire38 sites in 1 country161 target enrollmentMay 19, 2010

ConditionsADHD Specifically With Executive Function Impairment

InterventionsPlacebo SPD489

DrugsSPD489

Overview

Phase: Phase 4
Intervention: Placebo
Conditions: ADHD Specifically With Executive Function Impairment
Sponsor: Shire
Enrollment: 161
Locations: 38
Primary Endpoint: Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the efficacy of SPD489 compared to placebo on executive function (self-regulation) behaviors in adults with ADHD who report clinically significant impairment of executive function behavior in their everyday environment, as measured by the self-report Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A) Global Executive Composite (GEC) T-score.

Registry

clinicaltrials.gov

Start Date

May 19, 2010

End Date

November 29, 2010

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shire

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subject must be 18-55 years of age, inclusive at the time of consent.
•Subject has an established close relationship of at least 6-months duration before screening (Visit -1) with an informant who will be able to observe and be willing to report on the subject's behavior and symptoms in multiple social settings during the course of the study. Informant is defined as a person who has a domicile relationship with the subject. When applicable, the informant should be the subject's spouse/significant other. Additionally, the informant cannot participate as a subject in the study and can only serve as the informant for a single subject.
•Subject has a lifestyle that in the opinion of the Investigator will enable the subject to complete all study testing and requirements defined in the protocol.
•Female subjects must have a negative serum beta human chorionic gonadotropin (HCG) pregnancy test at screening (Visit -1) and a negative urine pregnancy test at baseline (Visit 0) and agree to comply with any applicable contraceptive requirements of the protocol.
•Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition - Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD (diagnostic code 314.00 and 314.01) established by a comprehensive psychiatric evaluation that reviews DSM-IV-TR criteria with at least 6 of the 9 subtype criteria met. The Adult ADHD Clinical Diagnostic Scale version 1.2 (ACDS v1.2) will be utilized as the diagnostic tool.
•Subject has a total score of ≥65 on BRIEF-A GEC T-score by self-report at baseline (Visit 0).
•Subject has a total score of ≥28 using the Adult ADHD-RS with prompts at baseline (Visit 0).
•Subject must have a minimum level of intellectual functioning as determined by the Investigator at screening (Visit -1).
•Subject is able to swallow a capsule.
•Subject is willing and able to comply with all the testing and requirements defined in this protocol.

Exclusion Criteria

Not provided

Arms & Interventions

Placebo

Intervention: Placebo

SPD489

Intervention: SPD489

Outcomes

Primary Outcomes

Change From Baseline in Subject-reported Behavior Rating Inventory of Executive Function - Adult Version Global Executive Composite T-score (BRIEF-A GEC T) at up to 10 Weeks

Time Frame: Baseline and up to 10 weeks

BRIEF-A Global Executive Composite assesses behavioral aspects of executive function. Items are rated 1 (never), 2 (sometimes), and 3 (often). There is no range for a total score. Raw scale scores are used to generate T-scores. A reduction in score indicates less impairment.

Secondary Outcomes

Change From Baseline in Adult ADHD Impact Module (AIM-A) Multi-Item Scales Total Score at up to 10 Weeks(Baseline and up to 10 weeks)
Change From Baseline in Informant-reported BRIEF-A T-scores at up to 10 Weeks(Baseline and up to10 weeks)
Change From Baseline in Subject-reported BRIEF-A T-scores at up to 10 Weeks(Baseline and up to 10 weeks)
Change From Baseline in Subject-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks(Baseline and up to 10 weeks)
Change From Baseline in Informant-reported BRIEF-A Clinical Subscales T-scores at up to 10 Weeks(Baseline and up to 10 weeks)
Change From Baseline in Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) With Adult Prompts Total Score at up to 10 Weeks(Baseline and up to 10 weeks)
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Baseline(Baseline)
Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at up to 10 Weeks(Up to 10 weeks post-dose)
Percent of Participants With Improvement on Clinical Global Impression - Global Improvement (CGI-I) at up to 10 Weeks(Up to 10 weeks post-dose)
Change From Baseline in AIM-A Multi-Item Scales of Living With ADHD and General Well-being Score at up to 10 Weeks(Baseline and up to 10 weeks)
Change From Baseline in AIM-A Quality of Life Questions 1 and 4 Scores at up to 10 Weeks(Baseline and up to 10 weeks)
Change From Baseline in Conner's Adult ADHD Rating Scale-Observer: Short Version (CAARS-O:S) ADHD Index T-score at up to 10 Weeks(Baseline and up to 10 weeks)
Change From Baseline in CAARS-O:S Factor-derived Subscale T-scores at up to 10 Weeks(Baseline and up to 10 weeks)
Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Total Score at up to 10 Weeks(Baseline and up to 10 weeks)