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Completed

NCT Number: NCT01070394

Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)

The purpose of this study is to examine the effectiveness and length of effect of Vyvanse on lessening Attention-Deficit/Hyperactivity Disorder symptoms in adults. The study will also investigate the safety and tolerability of Vyvanse in adults with ADHD.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU School of Medicine

New York, 10016, United States

About this study

Protocol Summary:

Effectiveness and Duration of Effect of Open Treatment in Adult ADHD Patients Treated with Lisdexamfetamine Dimesylate- LDX (Vyvanse)

The primary objective of this study is to evaluate the effectiveness and duration of effect of LDX for the treatment of ADHD symptoms in adults. The study will be a 12-week open label extension with 25 adult participants who completed a cross-over study of adherence/efficacy of Adderall Immediate Release (IR) vs. Adderall Extended Release (XR).

The secondary objective is to provide information regarding tolerability, dosing and titration of LDX in the adult population with ADHD.

An additional fifteen participants will be recruited using advertising and previous Mental Health and Addictive Behaviour Research Program (MHADRP) studies will be offered treatment with LDX. All participants will be diagnosed with ADHD using the Adult Clinician Diagnostic Scale (ACDS). We will be collecting demographic information, administering the Scheduled Clinical Interview for DSM Disorders (SCID), collecting medical history, previous drug therapy, and the participant will have a physical with the physician. A coordinator will give an electrocardiogram (ECG), and collect a blood sample for blood chemistry and hematology.

Schedule of Events: Vyvanse Extension Screening Visit

  • Consent
  • Demographics (needs to be added?)
  • Physical
  • Medical history (needs to be added?)
  • Previous drug therapy
  • Vitals (Blood Pressure-BP, Heart Rate-HR, Respiration, weight)
  • Urine Drug screen
  • Urine pregnancy test
  • ECG
  • Blood sample
  • SCID
  • ACDS

Visits at week 0,1,2,3,4,6,8,10,12 (every visit)

  • ADHD-Rating Scale (ADHD-RS)
  • Adult ADHD Self-Report Scale (ASRS)
  • Clinical Global Impression (CGI)
  • Vitals
  • Pill count
  • Adverse Events (AE)/ Concomitant Medications (CM)

Visits at week 0,1,4,6,12 also administer

  • Adult ADHD Medication Rebound Scale (AMRS) (AM/PM)
  • Adult ADHD Medication Smoothness of Effect Scale (AMSES) (AM/PM)
  • Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADS) (AM/PM)

First 4 weeks of treatment is a dose adjustment period (30-70 mg po qAM), after those 4 weeks established dose is remained for remaining 8 weeks of treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At the time of consent, are between the ages of 18-55, inclusive.
  • Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.2.
  • Female participants of childbearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study. Females of childbearing potential are defined as women not surgically sterilized and are between menarche and 2 years post-menopause.
  • Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing.
  • Must be able to swallow capsules.
  • Must be able to begin the daily dose of study medication in the morning.
  • Must be off all ADHD therapies for one week (psychostimulants) and three weeks (non-stimulants).
  • In the opinion of the investigator, the subject must understand and be able, willing and likely to fully comply with the study procedures and restrictions.
  • Must have given signed and dated informed consent in accordance with Good Clinical Practice (GCP) Guidelines.

Exclusion criteria

  • Participants with a positive urine drug result at Screening.
  • Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder (excluding nicotine).
  • Participants with controlled depressive or anxiety disorders may not participate if, in the opinion of the Principal Investigator, their medications will interfere with safety or efficacy assessments.
  • Participants with any concurrent chronic or acute illness or unstable medical condition that could, in the opinion of the study physician, confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
  • Participants with hypertension at screening, indicated by a blood pressure reading of 135/90 and heart rate above 120bmp.
  • Female participants of childbearing potential who test positive for pregnancy at the time of enrollment based on a urine pregnancy test, or who do not agree to use a reliable method of birth control during the study. Females of childbearing potential are defined as women not surgically sterilized and are between menarche and 2 years post-menopause.
  • Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
  • Participants who in the investigator's opinion meet any of the exclusionary criteria specified on the FDA label of Vyvanse.

Treatment and study plan

LDX Treatment

Drug

30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.

Other names: Vyvanse

Primary outcomes

  1. Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)

    Time frame: 12 weeks

    The ADHD-RS with adult ADHD prompts is a semi-structured scale that consists of 18 items that directly correspond to the 18 DSM-IV symptoms of ADHD, and is designed to assess current symptomatology19.

    Each item is scored on a 4-point scale ranging from 0 (none) to 3 (severe).Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. A score of 0-16 means "Unlikely to have ADHD"; a score of 17-23 "Likely to Have ADHD" ; 24 or greater-Highly Likely to have ADHD

Secondary outcomes

  1. Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS).

    Time frame: Week 0 to Week 12

    To evaluate the symptom rebound throughout a single day (assessed via the AMRS) with LDX treatment. Scoring on the AMRS based on 38 items, each scored 0 (None), 1 (Mild), 2 (Moderate), 3 (Severe). The lowest scored units on a scale for 1 individual is 0, the highest 114. The scores reported below are Mean scores for 33 patients analyzed.

  2. Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES)

    Time frame: Visits 0 and 12

    The Adult ADHD Medication Smoothness of Effect Scale (AMSES) is a 6-item, frequency-based, self-report scale that was recently developed to assess the consistency and duration of effect of ADHD medication throughout the day. The AMSES compares the effectiveness of ADHD medication shortly after dosing with the effectiveness later in the day. Respondents are asked to rate how frequently the effective-ness of their medication was the same 2 hr post-dose as it was 4, 6, 8, 10, and 12 hr post-dose on a 0 to 4 scale (0 = never, 1 = rarel, 2 = sometimes, 3 = often, 4 = very often). In addition, respondents rate how frequently the delivery of their medication was consistent and smooth throughout the day on a visual analog scale ranging from 0 (never) to 100 (very often).

  3. Correlation Between AMRS (In Clinic) and ADHD-RS

    Time frame: Visits 0 and 12

    To correlate symptom rebound through a single day (assessed via the AMRS) with a global (ADHD-RS) measure of efficacy of LDX treatment. AMRS and ADHD-RD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.

  4. Change in Correlation Between AMRS and TASS

    Time frame: Visits 0 and 12

    To correlate symptom rebound through a single day (assessed via the AMRS) with a time-sensitive (TASS) measure of efficacy of LDX treatment. A Pearson's correlation coefficient will be presented. AMRS and TASS scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.

  5. Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist

    Time frame: Baseline to Week 12

    To correlate symptom rebound through a single day (assessed via the AMRS) with a self assessment of ADHD Symptoms. A Pearson's correlation coefficient will be presented. AMRS and self assessment of ADHD scores obtained on Day 0 and Day 12 will be correlated. The Pearson's correlation coefficients for the In-Clinic assessment will be presented for Visits 0 and 12.

  6. Psychometric Validation of AMRS

    Time frame: Weeks 0-12

    To perform secondary psychometric validations of the AMRS using Cronbach's alpha coefficients.

  7. Psychometric Validation of AMSES

    Time frame: Weeks 0-12

    To perform secondary psychometric validations of the AMSES using Cronbach's alpha coefficients.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • Shire

Registry information

Official study title

Evaluation of Pharmacokinetics and Profile of Clinical Response of Subacute Lisdexamfetamine Dimesylate (Vyvanse) Treatment vs. Clinical Response to Subacute Immediate Release Mixed Amphetamine Salt Therapy in Adult ADHD

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 18, 2010
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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