Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder
Condition: Attention-deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Lisdexamfetamine dimesylate; Methylphenidate Hydrochloride; Placebo
Intervention description: Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance; Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance; Daily oral dosing in the AM for 8 weeks
Intervention MeSH terms: Methylphenidate; Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 464.0
Sex: All
Minimum age: 13 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      The purpose of this study is to determine effectiveness of Vyvanse compared to Concerta in
      adolescents with Attention-deficit/Hyperactivity Disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be 13-17 years of age, inclusive, at the time of consent.

          -  Subject must weigh more than 79.5lb.

          -  The parent/LAR must be available at approximately 7:00AM (±2 hours) to dispense the
             dose of investigational product for the study duration.

          -  Subject, who is a female, must have a negative serum beta human chorionic gonadotropin
             (β-HCG) pregnancy test and a negative urine pregnancy test and agree to comply with
             any applicable contraceptive requirements of the protocol.

          -  Subject has an ADHD-RS-IV total score ≥28.

          -  Subject is able to swallow a capsule.

          -  Subject does not have hypertension and has a resting sitting blood pressure less than
             or equal to 135/85mmHg.

        Exclusion Criteria

          -  Subject has a current, controlled (with medications prohibited in this study) or
             uncontrolled, comorbid psychiatric diagnosis with significant symptoms such as any
             significant comorbid Axis II disorder or significant Axis I disorder (such as post
             traumatic stress disorder, psychosis, bipolar illness, pervasive developmental
             disorder, severe obsessive compulsive disorder, depressive or anxiety disorder.

          -  Diagnosis of conduct disorder. Oppositional defiant disorder is not exclusionary.

          -  Subject is considered a suicide risk, has previously made a suicide attempt, or is
             currently demonstrating active suicidal ideation. Subjects with intermittent passive
             suicidal ideation are not necessarily excluded.

          -  Subject is underweight or overweight.

          -  Subject has a concurrent chronic or acute illness (such as severe allergic rhinitis or
             an infectious process requiring antibiotics), disability, or other condition. Mild,
             stable asthma is not exclusionary.

          -  Subject has a history of seizures (other than infantile febrile seizures), a chronic
             or current tic disorder, or a current diagnosis and/or a known family history of
             Tourette's Disorder.

          -  Subject has a known history of symptomatic cardiovascular disease, advanced
             arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm
             abnormalities, coronary artery disease, or other serious cardiac problems that may
             place him/her at increased vulnerability to the sympathomimetic effects of a stimulant
             medication.

          -  Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

          -  Subject has any clinically significant ECG or clinically significant laboratory
             abnormality.

          -  Subject has current abnormal thyroid function, defined as abnormal 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 documented allergy, hypersensitivity, or intolerance to amphetamine or
             to any excipients in the investigational product.

          -  Subject has a documented allergy, hypersensitivity, or intolerance to MPH or to any
             excipients in the reference product.

          -  Subject has failed to fully respond to an adequate course(s) (dose and duration) of
             MPH or amphetamine therapy.

          -  Subject has a history of suspected substance abuse or dependence disorder (excluding
             nicotine). Subjects with a lifetime history of amphetamine, cocaine, or other
             stimulant abuse and/or dependence will be excluded.

          -  Subject has a positive urine drug result.

          -  Subject has previously participated in this study or another clinical study involving
             SPD489/NRP104.

          -  Subject has glaucoma.

          -  Subject is required to take or anticipates the need to take medications that have CNS
             effects or affect performance, such as sedating antihistamines and decongestant
             sympathomimetics, or are monoamine oxidase inhibitors. Stable use of bronchodilator
             inhalers is not exclusionary.

          -  Subject is female and is pregnant or lactating.

          -  Subject is well controlled on his/her current ADHD medication.

          -  Subject has a pre-existing severe gastrointestinal tract narrowing.