Ignite Creation Date:
2025-12-25 @ 1:35 AM
Ignite Modification Date:
2025-12-26 @ 4:29 PM
Study NCT ID:
NCT01070394
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2010-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effectiveness and Duration of Effect of Open Treatment in Attention Deficit Hyperactivity Disorder (ADHD) Patients Treated With Lisdexamfetamine Dimesylate(Vyvanse)
Sponsor:
NYU Langone Health
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: