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

NCT01101022 | Completed Phase 4 Results

• 1 other identifier: SPD489-403
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 39

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.

Conditions

ADHD Specifically With Executive Function Impairment

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Baseline and up to 10 weeks

Secondary Outcomes (14)

• 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

Study Arms (2)

SPD489

ACTIVE COMPARATOR

Drug: SPD489

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

SPD489 DRUG

1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks)

Also known as: Vyvanse

SPD489

Placebo OTHER

1 capsule per day, daily throughout the double-blind treatment period (10 weeks)

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• Subject and informant must be able to provide written, personally signed and dated informed consent to participate in the study in accordance with the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and applicable regulations before completing any study related procedures.

You may not qualify if:

• Subject has a current comorbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms. Prohibited disorders include those associated with diagnoses including but not limited to any severe comorbid Axis II disorder or severe Axis I disorder (such as Post Traumatic Stress Disorder \[PTSD\], psychosis, bipolar illness, pervasive developmental disorder, severe obsessive compulsive disorder, severe depressive or severe anxiety disorder). Other symptomatic manifestations (such as agitated states) that contraindicate treatment with SPD489 or confound efficacy or safety assessments in the opinion of the examining physician are also prohibited. Comorbid psychiatric diagnoses will be established by the psychiatric evaluation that includes the Structured Clinical Interview for DSM-IV-TR disorders (SCID-I).
• Subjects who are currently considered a suicide risk, any subject who has previously made a suicide attempt or those who are currently demonstrating active suicidal ideation.
• The subject has a body mass index (BMI) of \<18.5 or ≥40.
• Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, a current diagnosis and/or a known family history of Tourette's Disorder.
• Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.
• Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
• Subject has any clinically significant ECG or clinically significant laboratory abnormality at screening (Visit -1).
• Subject has current abnormal thyroid function, defined as abnormal screening thyroid stimulating hormone (TSH) and thyroxine (T4). Treatment with a stable dose of thyroid medication for at least 3 months is permitted.
• Subject has a history of moderate to severe hypertension or has a resting sitting systolic blood pressure \>139mmHg or diastolic blood pressure \>89mmHg. Subjects with well-controlled mild or moderate hypertension on a single antihypertensive agent are allowed. Combination antihypertensive medications are not allowed.
• Subject is taking any medication that is excluded.
• Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.
• Subject has a documented allergy, hypersensitivity, or intolerance to any excipients in the investigational medicinal product.
• Subject has failed to respond to one or more adequate courses (dose and duration) of amphetamine therapy.
• Subject has a recent history (within the past 6 months) of suspected substance abuse or dependence disorder (excluding nicotine) in accordance with DSM-IV-TR criteria.
• Subject has a positive urine drug result at screening (Visit -1) (with the exception of subject's current stimulant therapy, if any).

Sponsors & Collaborators

• Shire: lead

Study Sites (39)

Clinical Study Centers, LLC

Little Rock, Arkansas, 72205, United States

Location

Peninsula Research Assoc, Inc

Rolling Hills Estates, California, 90274, United States

Location

PCSD Feighner Research

San Diego, California, 92108, United States

Location

Florida Clinical Research Center, LLC

Bradenton, Florida, 34208, United States

Location

Gulfcoast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Dr. George Joseph, MD and Associates PA

Jacksonville Beach, Florida, 32250, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

CNS Healthcare

Orlando, Florida, 32806, United States

Location

Janus Center For Psychiatric Research

West Palm Beach, Florida, 33407, United States

Location

Atlanta Center For Medical Research

Atlanta, Georgia, 30308, United States

Location

Northwest Behavioral Research Center

Marietta, Georgia, 30060, United States

Location

Capstone Clinical Research

Libertyville, Illinois, 60048, United States

Location

AMR-BABER Research Inc.

Naperville, Illinois, 60563, United States

Location

Psychiatric Associates

Overland Park, Kansas, 66211, United States

Location

Vince and Associates Clinical Research, Inc.

Overland Park, Kansas, 66211, United States

Location

Four Rivers Clinical Research

Paducah, Kentucky, 42003, United States

Location

Mark Hertzman MD, PC

Rockville, Maryland, 20852, United States

Location

Rochester Center for Behavioral Medicine

Rochester Hills, Michigan, 48307, United States

Location

The Behavioral Medicine Clinic of NW Michigan, PC

Traverse City, Michigan, 49686, United States

Location

Midwest Research Group

Saint Charles, Missouri, 63301, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Center for Emotional Fitness

Cherry Hill, New Jersey, United States

Location

Bioscience Research, LLC

Mount Kisco, New York, 10549, United States

Location

Mental Health and Addictive Disorders Research Program

New York, New York, 10016, United States

Location

Triangle Neuropsychiatry

Durham, North Carolina, 27707, United States

Location

Richard H. Weisler, MD, Pa & Associates

Raleigh, North Carolina, 27609, United States

Location

Oregon Center for Clinical Investigations, Inc.

Portland, Oregon, 97210, United States

Location

Occi, Inc (Oregon Center For Clinical Investigations, Inc.)

Salem, Oregon, 97301, United States

Location

FutureSearch Trials, LP

Austin, Texas, 78756, United States

Location

Bayou City Research, Ltd.

Houston, Texas, 77007, United States

Location

Red Oak Psychiatry Associates P.A.

Houston, Texas, 77090, United States

Location

John M. Turnbow, MD, PA

Lubbock, Texas, 79423, United States

Location

Vermont Clinical Study Center

Burlington, Vermont, 05401, United States

Location

Neuropsychiatric Associates

Woodstock, Vermont, 05091, United States

Location

Neuroscience, Inc

Herndon, Virginia, 20170, United States

Location

Eastside Therapeutic Resource

Kirkland, Washington, 98033, United States

Location

Summit Research Network, LLC

Seattle, Washington, 98104, United States

Location

Rockwood Clinic

Spokane, Washington, 99202, United States

Location

Dean Foundation for Health, Research and Education

Middleton, Wisconsin, 53562, United States

Location

Related Publications (3)

• Adler LA, Dirks B, Deas PF, Raychaudhuri A, Dauphin MR, Lasser RA, Weisler RH. Lisdexamfetamine dimesylate in adults with attention-deficit/ hyperactivity disorder who report clinically significant impairment in executive function: results from a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2013 Jul;74(7):694-702. doi: 10.4088/JCP.12m08144.

  PMID: 23945447 RESULT

• Brown TE, Chen J, Robertson B. Relationships Between Executive Function Improvement and ADHD Symptom Improvement With Lisdexamfetamine Dimesylate in Adults With ADHD and Executive Function Deficits: A Post Hoc Analysis. Prim Care Companion CNS Disord. 2020 May 28;22(3):19m02559. doi: 10.4088/PCC.19m02559.

  PMID: 32470230 DERIVED

• Adler LA, Dirks B, Deas P, Raychaudhuri A, Dauphin M, Saylor K, Weisler R. Self-Reported quality of life in adults with attention-deficit/hyperactivity disorder and executive function impairment treated with lisdexamfetamine dimesylate: a randomized, double-blind, multicenter, placebo-controlled, parallel-group study. BMC Psychiatry. 2013 Oct 9;13:253. doi: 10.1186/1471-244X-13-253.

  PMID: 24106804 DERIVED

MeSH Terms

Interventions

Lisdexamfetamine Dimesylate

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2010
• First Posted: April 9, 2010
• Study Start: May 19, 2010
• Primary Completion: November 29, 2010
• Study Completion: November 29, 2010
• Last Updated: June 9, 2021
• Results First Posted: February 13, 2012

Record last verified: 2021-05

Locations

US (39)