Clinical trial NCT01070394
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD Lisdexamfetamine Dimesylate Amphetamine
Sponsor: NYU Langone Health
Start date: 2010-02-01; Completion date: 2012-07-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

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.

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 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.

Arms: arm 1: 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.
Interventions: intervention 1: LDX Treatment
Intervention descriptions: intervention 1: 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.

Protocol documents: