Status:
COMPLETED
Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
Shire
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-25 years
Phase:
NA
Brief Summary
The aim of this study is to examine the mechanisms by which stimulant medications reduce symptoms in patients with Attention Deficit Hyperactivity Disorder (ADHD). Using Magnetic Resonance Imaging (MR...
Detailed Description
A cohort of 100 patients with ADHD will be recruited for a 12 week, double-blind, parallel, randomized controlled trial of Lisdexamfetamine (Vyvanse) versus placebo, with 50 patients randomized to Lis...
Eligibility Criteria
Inclusion
- ADHD Participants: Meets Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria for a primary diagnosis of ADHD, any subtype.
- Healthy Control Participants: No current DSM-IV-TR Axis I psychiatric diagnosis.
- All Participants:
- Male or female, 6 - 25 years of age, and in good physical health
- English-speaking
Exclusion
- Current comorbid DSM-IV-TR Axis I psychiatric diagnosis or other symptomatic manifestations that, in the opinion of the examining physician, will contraindicate Lisdexamfetamine treatment or confound safety assessments
- Meets DSM-IV-TR criteria for active substance abuse and/or dependence
- Lifetime history of cocaine or stimulant abuse or dependence
- Actively suicidal
- Children and adolescents: Prior treatment with psychostimulants for longer than 1 month duration and/or treatment with psychostimulants within the past 4 months Adults: Treatment with psychostimulants within the past 12 months.
- Documented allergy or intolerance to Lisdexamfetamine or other stimulant medications.
- Taking other medications with central nervous system effects.
- History of seizure (other than febrile seizure)
- Diagnosis of hyperthyroidism, glaucoma, or other serious medical illness.
- Personal or family history of medical conditions, such as cardiovascular disease, that may interfere with study participation, or for which treatment with Lisdexamfetamine may pose a risk
- Pregnant or lactating
- MRI contraindications such as pacemaker, braces, etc.
- Full scale intelligence quotient (FSIQ) less than 70
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT01415440
Start Date
August 1 2011
End Date
June 1 2018
Last Update
August 2 2022
Active Locations (1)
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1
New York State Psychiatric Institute
New York, New York, United States, 10032