Safety and Efficacy Workplace Environment Study of Lisdexamfetamine Dimesylate (LDX) in Adults With Attention-Deficit Hyperactivity Disorder (ADHD)
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: LDX; Placebo
Intervention description: oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting; Placebo administered once-daily for one week during the adult workplace environment setting
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 142.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of LDX compared to placebo in adults with ADHD in the adult
      workplace environment (AWE) setting
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be 18-55 years of age, inclusive at the time of consent.

          -  Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG)
             pregnancy test at Screening and a negative urine pregnancy test at Baseline and agree
             to comply with any applicable contraceptive requirements of the protocol.

          -  Subject meets 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 Baseline score of > or equal to 28 using the Adult ADHD-RS with prompts.

          -  Subject must have a minimum level of intellectual functioning, as determined by an
             Intelligent Quotient (IQ) score of 80 or above based on the Kaufman Brief Intelligence
             Test (KBIT).

        Exclusion Criteria:

          -  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. 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.

          -  Subject has a history of seizures (other than infantile febrile seizures), any tic
             disorder, or 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 current abnormal thyroid function, as defined as abnormal Screening
             thyroid stimulating hormone. 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.

          -  Subject has a documented allergy, hypersensitivity, or intolerance to amphetamines.

          -  Subject has failed to respond to one or more adequate courses (dose and duration) of
             amphetamine therapy.

          -  Subject has glaucoma.

          -  Subject is taking other medications that have central nervous system (CNS) effects or
             affect performance, such as sedating antihistamines and decongestant sympathomimetics,
             or are monoamine oxidase inhibitors (during or within 14 days of test or reference
             product administration). Stable use of bronchodilator inhalers is not exclusionary.

          -  Subject is female and pregnant or lactating.