Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT
Condition: Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Sluggish Cognitive Tempo (SCT) describes individuals who are dreamy, spacey, slow moving,
      hyper active, have difficulty initiating tasks, and often seem under-motivated and
      under-aroused. Barkley identified nine cardinal symptoms of SCT: 1) prone to daydreaming
      instead of concentrating; 2) trouble staying alert/awake in boring situations; 3) being
      easily confused; 4) being easily bored; 5) feeling spacey/in a fog; 6) frequently feeling
      lethargic; 7) being under-active/having less energy than others; 8) being slow moving; 9) not
      processing information quickly/accurately. Individuals were identified as SCT if they had at
      least 5 of 9 symptoms rated often or very often on the 9-item SCT subscale from the Barkley
      Adult ADHD Rating Scale-IV: Self-Report (BAARS-IV; hereafter called the Barkley SCT Scale).

      This is a 2 Site (NYU and Mount Sinai) Study of LDX in 50 adults with Attention Deficit
      Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). The study will be a double-blind,
      10-week, cross-over treatment trial of LDX (4 weeks; 30 - 70 mg/day) vs. placebo (4 weeks)
      with an intervening single- blind placebo washout period (2 weeks). During the LDX treatment
      period, LDX treatment will be initiated at a dose of 30mg/day at Visit 0 and can be titrated
      up (in the judgment of the investigator) in increments of 20mg, based upon clinical response
      and tolerability, to 50mg/day at Visit 1 and 70mg/day at Visit 2. Subjects receiving daily
      doses of 50mg or 70mg of LDX will be allowed to down titrate one dosage step of 20mg during
      Visits 2-4 if (in the judgment of the investigator) they are having issues in tolerability.
      The highest effective dose of LDX will then be maintained until Visit 4. Patients will be
      seen weekly throughout the trial except during placebo washout.
    

Intervention name(s): Lisdexamfetamine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment