Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

• ClinicalTrials.gov Identifier: NCT02635035
• Recruitment Status: Completed
• First Posted: December 18, 2015
• Last Update Posted: September 24, 2019
• Sponsor: NYU Langone Health
• Collaborator: Shire
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: November 18, 2015
• First Posted Date: December 18, 2015
• Last Update Posted Date: September 24, 2019
• Study Start Date: November 2015
• Actual Primary Completion Date: January 9, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: December 15, 2015): Changes in the number of symptoms present from the BAARS-IV; Barkley SCT Scale in adults with SCT or SCT and ADHD treated with lisdexamfetamine dimesylate (LDX) versus placebo. [ Time Frame: 10 Weeks ]
• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT02635035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: December 15, 2015)

• Changes in measure of arousal and motivation measured by BRIEF-A Metacognition Index and Motivation Subscales [ Time Frame: 10 Weeks ]
• Changes in score on neuropsychological tests of arousal and alerting, including: the Cambridge Neuropsychological Testing Automated Battery (CANTAB) ADHD battery [ Time Frame: 10 Weeks ]
• Changes in measures of reaction time and reaction time variability as measured by the Attention Switching Task (AST) [ Time Frame: 10 Weeks ]
• Changes in the measure of processing time measured by Wechsler Adult Intelligence Scale-IV [ Time Frame: 10 Weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT
• Official Title: Efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT)
• Brief 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.

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment

Condition

• Attention Deficit Disorder
• Attention Deficit Hyperactivity Disorder

Intervention

• Drug: Lisdexamfetamine
  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.
  Other Name: Vyvanse
• Drug: Placebo
  Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill.

Study Arms

• Experimental: Lisdexamfetamine First
  In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second
  Interventions:

  • Drug: Lisdexamfetamine
  • Drug: Placebo
• Experimental: Lisdexamfetamine Second
  In this crossover study design, participants assigned to this group will receive placebo first, then Lisdexamfetamine second
  Interventions:

  • Drug: Lisdexamfetamine
  • Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 23, 2019): 86
• Original Estimated Enrollment (submitted: December 15, 2015): 120
• Actual Study Completion Date: January 9, 2019
• Actual Primary Completion Date: January 9, 2019 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02635035
• Other Study ID Numbers: 13-01288
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: NYU Langone Health
• Study Sponsor: NYU Langone Health
• Collaborators: Shire

Investigators

• Principal Investigator: Lenard Adler, M.D.; NYU Medical College

• PRS Account: NYU Langone Health
• Verification Date: September 2019