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ClinicalTrials.gov public records Last synced Oct 2, 2026, 2:42 PM EDT

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Showing 1–24 of 29 matching trials from the live ClinicalTrials.gov search.
Filters: Intervention: lisdexamfetamine dimesylate (SPD489) Clear all
Terminated Phase 3 Interventional Results available

Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

NCT01760993
View directory record Official record
Conditions
Schizophrenia
Interventions
SPD489
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 65 Years
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013
U.S. locations
2
States / cities
Oklahoma City, Oklahoma • Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jun 22, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 2 Interventional Results available

Forced-dose Titration of SPD489 in Adults With Binge Eating Disorder

NCT01291173
View directory record Official record
Conditions
Binge Eating Disorder
Interventions
lisdexamfetamine dimesylate (SPD489), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
271 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
31
States / cities
Little Rock, Arkansas • Beverly Hills, California • La Jolla, California + 28 more
Source: ClinicalTrials.gov public record
Updated Jun 10, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

Open Label Extension in Adults With Binge Eating Disorder (BED)

NCT01657019
View directory record Official record
Conditions
Binge Eating Disorder
Interventions
Lisdexamfetamine dimesylate
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
604 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
84
States / cities
Birmingham, Alabama • Tucson, Arizona • Little Rock, Arkansas + 77 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

NCT01718483
View directory record Official record
Conditions
Binge Eating Disorder
Interventions
SPD489 (Lisdexamfetamine dimesylate), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
383 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
43
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Corona, California + 40 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 2 Interventional Results available

Exploratory Study of SPD489 in Adults With Major Depressive Disorder (MDD) as Augmentation Therapy to an Antidepressant

NCT00905424
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Antidepressant + SPD489 (lisdexamfetamine dimesylate), Antidepressant + placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
246 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
15
States / cities
Newport Beach, California • San Diego, California • Bradenton, Florida + 12 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

Safety and Tolerability Study of SPD489 in Preschool Children Aged 4-5 Years, Diagnosed With Attention-deficit/Hyperactivity Disorder

NCT02466386
View directory record Official record
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
SPD489
Drug
Lead sponsor
Shire
Industry
Eligibility
4 Years to 5 Years
Enrollment
113 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2020
U.S. locations
50
States / cities
Dothan, Alabama • Little Rock, Arkansas • Imperial, California + 41 more
Source: ClinicalTrials.gov public record
Updated Mar 5, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 4 Interventional Results available

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

NCT01101022
View directory record Official record
Conditions
ADHD Specifically With Executive Function Impairment
Interventions
SPD489, Placebo
Drug · Other
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
161 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010
U.S. locations
39
States / cities
Little Rock, Arkansas • Rolling Hills Estates, California • San Diego, California + 34 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

Evaluate the Maintenance of Efficacy of SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

NCT02009163
View directory record Official record
Conditions
Binge Eating Disorder
Interventions
Lisdexamfetamine dimesylate, Placebo
Drug · Other
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
418 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
39
States / cities
Fort Myers, Florida • Lauderhill, Florida • Leesburg, Florida + 35 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

SPD489 in Adults Aged 18-55 Years With Moderate to Severe Binge Eating Disorder

NCT01718509
View directory record Official record
Conditions
Binge Eating Disorder
Interventions
SPD489 (Lisdexamfetamine dimesylate), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
390 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
45
States / cities
Tucson, Arizona • Beverly Hills, California • La Jolla, California + 42 more
Source: ClinicalTrials.gov public record
Updated Jul 16, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 2 Interventional Results available

Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms

NCT00922272
View directory record Official record
Conditions
Schizophrenia and Predominant Negative Symptoms
Interventions
SPD489 (lisdexamfetamine dimesylate), Placebo matching SPD489 (lisdexamfetamine dimesylate)
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
92 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
27
States / cities
Little Rock, Arkansas • Anaheim, California • Costa Mesa, California + 21 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Terminated Phase 3 Interventional Results available

Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

NCT01738698
View directory record Official record
Conditions
Schizophrenia
Interventions
SPD489 40mg, SPD489 100mg, SPD489 160mg, Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 65 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2013
U.S. locations
1
States / cities
Irving, Texas
Source: ClinicalTrials.gov public record
Updated Jun 22, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 2 Interventional Results available

SPD489 in Adults With Persistent Executive Function Impairments (EFI) and Partial or Full Remission of Recurrent Major Depressive Disorder

NCT00985725
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
SPD489 (Lisdexamfetamine dimesylate), Matching placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
143 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
33
States / cities
Imperial, California • Los Alamitos, California • Oceanside, California + 28 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

NCT01436149
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
SPD489 (Lisdexamfetamine dimesylate ), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,262 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2013
U.S. locations
47
States / cities
Birmingham, Alabama • Carson, California • Irvine, California + 42 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Terminated Phase 3 Interventional Results available

SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

NCT01436175
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,570 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2014
U.S. locations
140
States / cities
Birmingham, Alabama • Scottsdale, Arizona • Little Rock, Arkansas + 113 more
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy Study in Preschool Children Aged 4-5 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

NCT03260205
View directory record Official record
Conditions
Attention Deficit Hyperactivity Disorder (ADHD)
Interventions
Placebo, SPD489 (Lisdexamfetamine dimesylate), SPD489
Drug
Lead sponsor
Shire
Industry
Eligibility
4 Years to 5 Years
Enrollment
199 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
48
States / cities
Dothan, Alabama • Little Rock, Arkansas • Colton, California + 39 more
Source: ClinicalTrials.gov public record
Updated Jun 8, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)

NCT00697515
View directory record Official record
Conditions
ADHD
Interventions
LDX, Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
142 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2008
U.S. locations
5
States / cities
Little Rock, Arkansas • Irvine, California • Overland Park, Kansas + 2 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Terminated Phase 3 Interventional Results available

SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

NCT01760889
View directory record Official record
Conditions
Schizophrenia
Interventions
SPD489 low dose range (40mg, 80mg, and 100mg), SPD489 high dose range (120mg, 140mg and 160mg), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 65 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013
U.S. locations
4
States / cities
Miami Springs, Florida • O'Fallon, Missouri • Saint Charles, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 2 Interventional Results available

SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

NCT01435759
View directory record Official record
Conditions
Major Depressive Disorder
Interventions
Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg, Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg, Antidepressant + Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,197 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2014
U.S. locations
60
States / cities
Little Rock, Arkansas • Anaheim, California • Chino, California + 54 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

Co-Administration of LDX (SPD489) and Venlafaxine XR (EFFEXOR XR) in Healthy Volunteers

NCT01235338
View directory record Official record
Conditions
Healthy
Interventions
LDX + Venlafaxine XR, Venlafaxine XR + LDX
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 45 Years
Enrollment
80 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010 – 2011
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Withdrawn Phase 3 Interventional

Safety and Efficacy of SPD489 in Adolescent Subjects Aged 13-17 Years With Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT01274221
View directory record Official record
Conditions
ADHD
Interventions
SPD489, Placebo
Drug · Other
Lead sponsor
Shire
Industry
Eligibility
13 Years to 17 Years
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
6
States / cities
Little Rock, Arkansas • Bradenton, Florida • Overland Park, Kansas + 3 more
Source: ClinicalTrials.gov public record
Updated Jun 3, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 4 Interventional Results available

Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder

NCT00877487
View directory record Official record
Conditions
Attention-Deficit/Hyperactivity Disorder
Interventions
SPD489 (Lisdexamfetamine dimesylate), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 55 Years
Enrollment
123 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2010
U.S. locations
55
States / cities
Little Rock, Arkansas • El Centro, California • Rolling Hills Estates, California + 51 more
Source: ClinicalTrials.gov public record
Updated Jun 22, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 2 Interventional Accepts healthy volunteers Results available

Pharmacodynamic Profile of SPD489 in Healthy Adult Males Undergoing a Nocturnal Period of Acute Sleep Loss

NCT01096680
View directory record Official record
Conditions
Sleep Deprivation
Interventions
SPD489 20 mg, SPD489 50 mg, SPD489 70 mg, Armodafinil, Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 40 Years · Male only
Enrollment
135 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2010
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Jun 14, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 3 Interventional Results available

Double-blind, Placebo-controlled, Randomised Withdrawal, Extension, Safety and Efficacy Study of LDX in Children and Adolescents Aged 6-17

NCT00784654
View directory record Official record
Conditions
ADHD
Interventions
Lisdexamfetamine dimesylate (LDX), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
6 Years to 17 Years
Enrollment
276 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2011
U.S. locations
4
States / cities
Rolling Hills Estates, California • South Miami, Florida • Overland Park, Kansas + 1 more
Source: ClinicalTrials.gov public record
Updated Jun 9, 2021 · Synced Oct 2, 2026, 2:42 PM EDT
Completed Phase 1 Interventional Results available

Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia

NCT01457339
View directory record Official record
Conditions
Schizophrenia
Interventions
SPD489 (Lisdexamfetamine dimesylate), Placebo
Drug
Lead sponsor
Shire
Industry
Eligibility
18 Years to 65 Years
Enrollment
31 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2012
U.S. locations
2
States / cities
Glendale, California • Long Beach, California
Source: ClinicalTrials.gov public record
Updated Jun 3, 2021 · Synced Oct 2, 2026, 2:42 PM EDT