Effectiveness and Duration of Effect of Open Treatment in Adult Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate- LDX (Vyvanse)
Attention Deficit Hyperactivity Disorder
Drug: Lisdexamfetamine Dimesylate-LDX
|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)|
- 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.
|Study Start Date:||October 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
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|
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
- Demographics (needs to be added?)
- Medical history (needs to be added?)
- Previous drug therapy
- Vitals (BP, HR, Resp, weight)
- Urine Drug screen
- Urine pregnancy test
- Blood sample
Visits at week 0,1,2,3,4,6,8,10,12 (every visit)
- Pill count
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070394
|United States, New York|
|NYU School of Medicine|
|New York, New York, United States, 10010|