Trial record 1 of 1 for:    NCT01070394
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Effectiveness and Duration of Effect of Open Treatment in Adult Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate- LDX (Vyvanse)

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Lenard Adler, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01070394
First received: February 16, 2010
Last updated: March 11, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Attention Deficit Hyperactivity Disorder
Drug: Lisdexamfetamine Dimesylate-LDX
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness and Duration of Effect of Open Treatment in Adult ADHD Patients Treated With Lisdexamfetamine Dimesylate- LDX (Vyvanse)

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Assess pharmokinetics of LDX in adults with ADHD, assessing plasma d-apmhetamine levels [ Time Frame: 12-hour post-dose period during subacute LDX treatment ] [ Designated as safety issue: No ]
    The primary objective is to assess the pharmokinetics of LDX in adults with ADHD, assessing plasma d-amphetamine levels throughout a 12-hour post-dose period during subacute LDX treatment (week 6, v6 of study and fifth week of LDX treatment). The co-primary objective is to compare effects on ADHD symptoms via ADHD-RS during LDX vs. MAS-IR therapy.


Enrollment: 20
Study Start Date: October 2007
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment arm
The treatment arm will receive 5 weeks of Lisdexamfetamine Dimesylate-LDX treatment and 5 weeks of MAS-IR treatment with a 3-week placebo washout period in between treatment phases.
Drug: Lisdexamfetamine Dimesylate-LDX

Detailed Description:

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 IR vs. Adderall XR.

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

Fifteen participants will be recruited using advertising and previous MHADRP studies will be offered treatment with LDX. All participants will be diagnosed with ADHD using the Adult Clinician Diagnostic Scale. We will be collecting demographic information, administering the SCID, collecting medical history, previous drug therapy, and the participant will have a physical with the physician. A coordinator will give an 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 (BP, HR, Resp, weight)
  • Urine Drug screen
  • Urine pregnancy test
  • EKG
  • Blood sample
  • SCID
  • ACDS

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

  • ADHD-RS
  • ASRS
  • CGI
  • Vitals
  • Pill count
  • AE/CM

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

  • AMRS (AM/PM)
  • AMSES (AM/PM)
  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At the time of consent, are between the ages of 18-55, inclusive.
  2. Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.2.
  3. 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.
  4. Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing.
  5. Must be able to swallow capsules.
  6. Must be able to begin the daily dose of study medication in the morning.
  7. Must be off all ADHD therapies for one week (psychostimulants) and three weeks (non-stimulants).
  8. 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.
  9. Must have given signed and dated informed consent in accordance with Good Clinical Practice (GCP) Guidelines.

Exclusion Criteria:

  1. Participants with a positive urine drug result at Screening.
  2. Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder (excluding nicotine).
  3. 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.
  4. 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.
  5. Participants with hypertension at screening, indicated by a blood pressure reading of 135/90 and heart rate above 120bmp.
  6. 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.
  7. Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
  8. Participants who in the investigator's opinion meet any of the exclusionary criteria specified on the FDA label of Vyvanse.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01070394

Locations
United States, New York
NYU School of Medicine
New York, New York, United States, 10010
Sponsors and Collaborators
New York University School of Medicine
Shire
  More Information

No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lenard Adler, Principal Investigator, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01070394     History of Changes
Other Study ID Numbers: 00909
Study First Received: February 16, 2010
Last Updated: March 11, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by New York University School of Medicine:
ADHD

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on August 01, 2014