Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT
Condition: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Lisdexamfetamine; Placebo
Intervention description: Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.; Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With
      Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a
      placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day
      in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive Tempo (ACT).
      Patients will be assigned either LDX/Placebo for 10 weeks with a two week placebo washout
      period.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female between the ages of 18-60 of all races and ethnicity.

          2. Meets DSM-IV-TR criteria for a primary diagnosis of inattentive or combined type ADHD
             as diagnosed via the Adult ADHD Clinician Diagnostic Scale

          3. For the Sluggish Cognitive Tempo+ group Must Score ≥ 5 items on the Barkley Sluggish
             Cognitive Tempo Scale; Must be rated 3 ("often") or ("very often") and total Sluggish
             Cognitive Tempo symptom score ≥ 26; must have a T-score ≥ 65 on the Metacognition
             Index and Motivation Subscales of the Behavior RatingInventory of Executive Function -
             Adult Version (BRIEF-A)

          4. Impairment: must have a total score > 95th percentile on the Barkley Functional
             Impairment Rating Screen (Barkley Functional Impairment Scale (BFIS).

          5. For the Sluggish Cognitive Tempo - group, < 5 items on the Barkley SCT Scale must be
             rated 3 ("often") or 4 ("very often") and total SCT symptom score < 26; must have a
             T-score < 65 on the Metacognition Index and Motivation Subscales of the BRIEF-A.

        Exclusion Criteria:

          1. Meets DSM-IV-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD.

          2. Any other current psychiatric disorder, determined via the M.I.N.I , which requires
             pharmacotherapy treatment.

          3. Current suicidal ideation or history of suicide attempts, based on the Columbia-
             Suicide Severity Rating Scale(C-SSRS).

          4. Lifetime history of bipolar disorder or any psychotic disorder as per the M.I.N.I

          5. Pregnant, breastfeeding or women planning to become pregnant.

          6. Positive urine drug toxicology are excluded.