Lisdexamfetamine

Generic Name: Lisdexamfetamine

Brand Names: Vyvanse

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₂₅N_₃O

CAS Number: 608137-32-2

Unique Ingredient Identifier: H645GUL8KJ

Background: Lisdexamfetamine is a prodrug of dextroamphetamine, a central nervous system stimulant known as d-amphetamine, covalently attached to the naturally occurring amino acid L-lysine. Lisdexamfetamine is the first chemically formulated prodrug stimulant and was first approved by the FDA in April 2008. It was also approved by Health Canada in February 2009. Lisde...

Indication: Lisdexamfetamine is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients six years and older. It is also indicated to treat moderate to severe binge eating disorder (BED) in adults. It is approved for use in the US and Canada.

Associated Conditions: Attention Deficit Hyperactivity Disorder (ADHD), Moderate Binge Eating Disorder (BED), Severe Binge Eating Disorder (BED)

Associated Therapies: -

Clinical Trials

To Evaluate the Safety and Metabolic Profile of Vyvanse for the Treatment of ADHD in Euthymic Adults With Bipolar I/II Disorder

Completed

Conditions: Attention Deficit/Hyperactivity Disorder
Bipolar Disorder

Interventions: Drug: lisdexamfetamine dimesylate

First Posted Date: 2010-12-20

Last Posted Date: 2012-06-01

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 45

Registration Number: NCT01263548

Locations: 🇨🇦
Mood Disorders Psychopharmacology Unit, Toronto, Ontario, Canada

Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

Phase 3

Terminated

Conditions: Bipolar
Depression

Interventions: Drug: Lisdexamfetamine
Drug: Placebo control

First Posted Date: 2010-05-27

Last Posted Date: 2014-03-05

Lead Sponsor: Lindner Center of HOPE

Target Recruit Count: 50

Registration Number: NCT01131559

Locations: 🇺🇸
Lindner Center of HOPE, Mason, Ohio, United States

Does Pharmacological Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Adults Enhance Parenting Performance?

Phase 4

Completed

Conditions: ADHD

Interventions: Drug: lisdexamfetamine

First Posted Date: 2010-05-21

Last Posted Date: 2014-06-13

Lead Sponsor: Florida International University

Target Recruit Count: 38

Registration Number: NCT01127607

Locations: 🇺🇸
Florida International University, Miami, Florida, United States

Comparison of Lisdexamfetamine Dimesylate With Atomoxetine HCl in Attention-Deficit/Hyperactivity Disorder (ADHD) Subjects With an Inadequate Response to Methylphenidate

Phase 3

Completed

Conditions: Attention-Deficit/Hyperactivity Disorder

Interventions: Drug: Atomoxetine Hydrochloride
Drug: Lisdexamfetamine Dimesylate

First Posted Date: 2010-04-19

Last Posted Date: 2021-06-11

Lead Sponsor: Shire

Target Recruit Count: 267

Registration Number: NCT01106430

Locations: 🇺🇸
Midwest Research Group/Saint Charles Psychiatric Associates, Saint Charles, Missouri, United States
🇨🇦
The Kids Clinic, Whitby, Ontario, Canada
🇺🇸
Innovis Health, Fargo, North Dakota, United States

and more 61 locations

Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Phase 3

Terminated

Conditions: Bipolar Depression

Interventions: Drug: Placebo
Drug: Lisdexamfetamine

First Posted Date: 2010-03-26

Last Posted Date: 2015-09-02

Lead Sponsor: Lindner Center of HOPE

Target Recruit Count: 25

Registration Number: NCT01093963

Locations: 🇺🇸
Lindner Center of HOP, Mason, Ohio, United States

Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

Phase 3

Completed

Conditions: Binge Eating Disorder

Interventions: Drug: lisdexamfetamine
Drug: Placebo control

First Posted Date: 2010-03-22

Last Posted Date: 2016-07-15

Lead Sponsor: Lindner Center of HOPE

Target Recruit Count: 50

Registration Number: NCT01090713

Locations: 🇺🇸
Lindner Center of HOPE, Mason, Ohio, United States

Efficacy and Safety of Lisdexamfetamine Dimesylate in Adults With Chronic Fatigue Syndrome

Phase 4

Completed

Conditions: Chronic Fatigue Syndrome
Cognitive Impairments

Interventions: Drug: Placebo "30, 50 or 70 mg"
Drug: Lisdexamfetamine Dimesylate

First Posted Date: 2010-02-18

Last Posted Date: 2015-04-03

Lead Sponsor: Rochester Center for Behavioral Medicine

Target Recruit Count: 26

Registration Number: NCT01071044

Locations: 🇺🇸
Rochester Center for Behavioral Medicine, Rochester Hills, Michigan, United States

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

Phase 4

Terminated

Conditions: Bipolar Depression

Interventions: Drug: Placebo
Drug: Lisdexamfetamine

First Posted Date: 2010-01-18

Last Posted Date: 2013-01-30

Lead Sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.

Target Recruit Count: 2

Registration Number: NCT01051440

Locations: 🇺🇸
Steward St. Elizabeth's Medical Center, Boston, Massachusetts, United States

Treatment of Traumatic Brain Injury (TBI)-Related Attention Deficits

Phase 3

Terminated

Conditions: Traumatic Brain Injury
Attention Deficit Disorder

Interventions: Drug: Vyvanse
Procedure: fMRI
Drug: Placebo

First Posted Date: 2009-10-22

Last Posted Date: 2017-05-19

Lead Sponsor: Vanderbilt University

Target Recruit Count: 22

Registration Number: NCT01000064

Locations: 🇺🇸
Vanderbilt University, Nashville, Tennessee, United States

A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: SPD503 and VYVANSE
Drug: SPD503
Drug: VYVANSE

First Posted Date: 2009-06-12

Last Posted Date: 2021-06-14

Lead Sponsor: Shire

Target Recruit Count: 42

Registration Number: NCT00919867

Locations: 🇺🇸
Advanced Biomedical Research, Inc., Hackensack, New Jersey, United States

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