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Shire SCT: Lisdexamfetamine Treatment for ADHD and SCT

NCT02635035 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2021-11-16

Study results available
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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

Interventions

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.

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Lenard Adler, M.D. · NYU Medical College

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2019-01-09
Completion
2019-01-09
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02635035 on ClinicalTrials.gov