Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

• Status: Completed
• Trial end date: 2019-01-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborator: Shire
• Treatments: Lisdexamfetamine Dimesylate

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.