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Completed Phase 4 Interventional Results available

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

ClinicalTrials.gov ID: NCT01101022

Public ClinicalTrials.gov record NCT01101022. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 27, 2026, 10:40 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01101022
Recruitment status
Completed
Study type
Interventional
Phase
Phase 4
Lead sponsor
Shire
Industry
Enrollment
161 participants

Conditions and interventions

Interventions

Drug · Other

Eligibility (public fields only)

Age range
18 Years to 55 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 19, 2010 (Actual)
Primary completion
Nov 29, 2010 (Actual)
Completion
Nov 29, 2010 (Actual)
Last update posted
Jun 9, 2021

2010

United States locations

U.S. sites
39
U.S. states
20
U.S. cities
37
Facility City State ZIP Site status
Clinical Study Centers, LLC Little Rock Arkansas 72205 —
Peninsula Research Assoc, Inc Rolling Hills Estates California 90274 —
PCSD Feighner Research San Diego California 92108 —
Florida Clinical Research Center, LLC Bradenton Florida 34208 —
Gulfcoast Clinical Research Center Fort Myers Florida 33912 —
Dr. George Joseph, MD and Associates PA Jacksonville Beach Florida 32250 —
Florida Clinical Research Center, LLC Maitland Florida 32751 —
CNS Healthcare Orlando Florida 32806 —
Janus Center For Psychiatric Research West Palm Beach Florida 33407 —
Atlanta Center For Medical Research Atlanta Georgia 30308 —
Northwest Behavioral Research Center Marietta Georgia 30060 —
Capstone Clinical Research Libertyville Illinois 60048 —
AMR-BABER Research Inc. Naperville Illinois 60563 —
Psychiatric Associates Overland Park Kansas 66211 —
Vince and Associates Clinical Research, Inc. Overland Park Kansas 66211 —
Four Rivers Clinical Research Paducah Kentucky 42003 —
Mark Hertzman MD, PC Rockville Maryland 20852 —
Rochester Center for Behavioral Medicine Rochester Hills Michigan 48307 —
The Behavioral Medicine Clinic of NW Michigan, PC Traverse City Michigan 49686 —
Midwest Research Group Saint Charles Missouri 63301 —
Center for Psychiatry and Behavioral Medicine, Inc. Las Vegas Nevada 89128 —
Center for Emotional Fitness Cherry Hill New Jersey — —
Bioscience Research, LLC Mount Kisco New York 10549 —
Mental Health and Addictive Disorders Research Program New York New York 10016 —
Triangle Neuropsychiatry Durham North Carolina 27707 —
Richard H. Weisler, MD, Pa & Associates Raleigh North Carolina 27609 —
Oregon Center for Clinical Investigations, Inc. Portland Oregon 97210 —
Occi, Inc (Oregon Center For Clinical Investigations, Inc.) Salem Oregon 97301 —
FutureSearch Trials, LP Austin Texas 78756 —
Bayou City Research, Ltd. Houston Texas 77007 —
Red Oak Psychiatry Associates P.A. Houston Texas 77090 —
John M. Turnbow, MD, PA Lubbock Texas 79423 —
Vermont Clinical Study Center Burlington Vermont 05401 —
Neuropsychiatric Associates Woodstock Vermont 05091 —
Neuroscience, Inc Herndon Virginia 20170 —
Eastside Therapeutic Resource Kirkland Washington 98033 —
Summit Research Network, LLC Seattle Washington 98104 —
Rockwood Clinic Spokane Washington 99202 —
Dean Foundation for Health, Research and Education Middleton Wisconsin 53562 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01101022, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 9, 2021 · Synced Oct 27, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01101022 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →