Phase 2
N=38
Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT
Attention Deficit Disorder · Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02635035 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV) — 23.27; 23.1 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lisdexamfetamine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV) |
23.27; 23.1 | — |
| SECONDARY Change in Score on Barkley Functional Impairment Scale (BFIS) |
4.93; 4.88 | — |
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
- Male or female between the ages of 18-60 of all races and ethnicity.
- Meets DSM-IV-TR criteria for a primary diagnosis of inattentive or combined type ADHD as diagnosed via the Adult ADHD Clinician Diagnostic Scale
- 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)
- Impairment: must have a total score > 95th percentile on the Barkley Functional Impairment Rating Screen (Barkley Functional Impairment Scale (BFIS).
- 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
- Meets DSM-IV-TR criteria for a primary diagnosis of hyperactive-impulsive type ADHD.
- Any other current psychiatric disorder, determined via the M.I.N.I , which requires pharmacotherapy treatment.
- Current suicidal ideation or history of suicide attempts, based on the Columbia- Suicide Severity Rating Scale(C-SSRS).
- Lifetime history of bipolar disorder or any psychotic disorder as per the M.I.N.I
- Pregnant, breastfeeding or women planning to become pregnant.
- Positive urine drug toxicology are excluded.
Data sourced from ClinicalTrials.gov (NCT02635035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.