Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

NCT02635035 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 13-01288
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 2

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.

Conditions

Attention Deficit Disorder; Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Score on Barkley Adult ADHD Rating Scale-IV (BAARS-IV)

  The BAARS-IV Self-Report consists of 27 symptoms that can be rated from 1 (never or rarely) to 4 (very often). The total range of scores is 1-108; a higher score indicates ADHD symptoms at a higher frequency.

  Baseline, 10 Weeks

Secondary Outcomes (1)

• Change in Score on Barkley Functional Impairment Scale (BFIS)

  Baseline, 10 weeks

Study Arms (2)

Lisdexamfetamine First

EXPERIMENTAL

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

Drug: Lisdexamfetamine; Drug: Placebo

Lisdexamfetamine Second

EXPERIMENTAL

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

Drug: Lisdexamfetamine; Drug: Placebo

Interventions

Lisdexamfetamine DRUG

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.

Also known as: Vyvanse

Lisdexamfetamine First; Lisdexamfetamine Second

Placebo DRUG

Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill.

Lisdexamfetamine First; Lisdexamfetamine Second

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Shire: collaborator

Study Sites (2)

Mount Sinai School of Medicine

New York, New York, 10016, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (1)

• Adler LA, Leon TL, Sardoff TM, Krone B, Faraone SV, Silverstein MJ, Newcorn JH. A Placebo-Controlled Trial of Lisdexamfetamine in the Treatment of Comorbid Sluggish Cognitive Tempo and Adult ADHD. J Clin Psychiatry. 2021 Jun 29;82(4):20m13687. doi: 10.4088/JCP.20m13687.

  PMID: 34232582 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Terry Leon
• Organization: NYU Langone Health

Terry.Leon@nyulangone.org

1 646 754 4841

Study Officials

• Lenard Adler, M.D.

  NYU Medical College

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2015
• First Posted: December 18, 2015
• Study Start: November 1, 2015
• Primary Completion: January 9, 2019
• Study Completion: January 9, 2019
• Last Updated: November 16, 2021
• Results First Posted: November 16, 2021

Record last verified: 2021-10

Locations

US (2)