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Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

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ClinicalTrials.gov Identifier: NCT02635035
Recruitment Status : Recruiting
First Posted : December 18, 2015
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder Attention Deficit Hyperactivity Disorder Drug: Lisdexamfetamine Drug: Placebo Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT)
Study Start Date : November 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lisdexamfetamine First
In this crossover study design, participants assigned to this group will receive Lisdexamfetamine first, then placebo second
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.

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




Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02635035


Contacts
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Contact: Glenn Hirsch, MD hirscg01@nyumc.org
Contact: Terry Leon, MD +1 646 754 4837 guzmat01@nyumc.org

Locations
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United States, New York
Mount Sinai School of Medicine Recruiting
New York, New York, United States, 10016
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Terry Leon, M.D.    646-754-4837    guzmat01@nyumc.org   
Principal Investigator: Lenard Adler, M.D.         
Sponsors and Collaborators
New York University School of Medicine
Shire
Investigators
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Principal Investigator: Lenard Adler, M.D. NYU Medical College

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Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02635035     History of Changes
Other Study ID Numbers: 13-01288
First Posted: December 18, 2015    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

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

Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents