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

NCT01070394 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 10-00510
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Lisdexamfetamine Dimesylate; Amphetamine

Outcome Measures

Primary Outcomes (1)

• Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)

  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

  12 weeks

Secondary Outcomes (7)

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

  Week 0 to Week 12

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

  Visits 0 and 12

• Correlation Between AMRS (In Clinic) and ADHD-RS

  Visits 0 and 12

• Change in Correlation Between AMRS and TASS

  Visits 0 and 12

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

  Baseline to Week 12

Study Arms (1)

LDX Treatment

EXPERIMENTAL

Eligible participants received 12 weeks of open-label treatment. Those on treatment prior to baseline underwent a 7-day (for amphetamine or methylphenidate) or 28-day (for atomoxetine or other medications) washout period prior to initiating LDX treatment. The starting dose was 30mg/day, which could be titrated up by 20mg/day during visits 2-6 (for a maximum dose of 70mg/day). At discretion of investigator, the dose could be down-titrated by 20mg/day during visits 4-6. Once the dose was optimized (after visit 6), the dose was maintained for 8 weeks.

Drug: LDX Treatment

Interventions

LDX Treatment DRUG

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

Also known as: Vyvanse

LDX Treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• Shire: collaborator

Study Sites (1)

NYU School of Medicine

New York, New York, 10016, United States

Location

Related Publications (2)

• Adler LA, Alperin S, Leon T, Faraone S. Clinical effects of lisdexamfetamine and mixed amphetamine salts immediate release in adult ADHD: results of a crossover design clinical trial. Postgrad Med. 2014 Sep;126(5):17-24. doi: 10.3810/pgm.2014.09.2796.

  PMID: 25295646 DERIVED

• Mattingly GW, Weisler RH, Young J, Adeyi B, Dirks B, Babcock T, Lasser R, Scheckner B, Goodman DW. Clinical response and symptomatic remission in short- and long-term trials of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. BMC Psychiatry. 2013 Jan 29;13:39. doi: 10.1186/1471-244X-13-39.

  PMID: 23356790 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: Dr. Lenard Adler
• Organization: NYU School of Medicine

lenard.adler@nyumc.org

(212) 263-3580

Study Officials

• Lenard Adler, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2010
• First Posted: February 18, 2010
• Study Start: February 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 3, 2018
• Results First Posted: November 25, 2016

Record last verified: 2018-03

Locations

US (1)