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Safety and Efficacy of SPD489 on Executive Function Behaviors in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

2014-08-27 03:14:40 | BioPortfolio

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.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

ADHD Specifically With Executive Function Impairment

Intervention

SPD489, Placebo

Location

Clinical Study Centers, LLC
Little Rock
Arkansas
United States
72205

Status

Recruiting

Source

Shire Pharmaceutical Development

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:40-0400

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Medical and Biotech [MESH] Definitions

A set of cognitive functions that controls complex, goal-directed thought and behavior. Executive function involves multiple domains, such as CONCEPT FORMATION, goal management, cognitive flexibility, INHIBITION control, and WORKING MEMORY. Impaired executive function is seen in a range of disorders, e.g., SCHIZOPHRENIA; and ADHD.

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Ratings that express in numerical values the degree of impairment or abnormality in the function of specific organs.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

Psychiatric illness or diseases manifested by breakdowns in the adaptational process expressed primarily as abnormalities of thought, feeling, and behavior producing either distress or impairment of function.

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