Back to resultsImaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lisdexamfetamine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring ADHD, Vyvanse, stimulant medication, ADD
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
- 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
Sites / Locations
- New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Psychostimulant
Placebo
Arm Description
30-70 mg capsule of Lisdexamfetamine once daily for 12 weeks
30-70 mg capsule of placebo (sugar pill) once daily for 12 weeks
Outcomes
Primary Outcome Measures
Brain Structure Volume
Brain structure volume measured in mm^3
Secondary Outcome Measures
Full Information
NCT ID
NCT01415440
First Posted
July 26, 2011
Last Updated
July 29, 2022
Sponsor
New York State Psychiatric Institute
Collaborators
Shire
1. Study Identification
Unique Protocol Identification Number
NCT01415440
Brief Title
Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD
Official Title
Examining the Effects of Stimulant Medication on Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
August 2011 (Actual)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
Shire
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 (MRI), the investigators have found that the volumes of certain brain regions are reduced in patients with ADHD. The reduced volumes were much less pronounced if patients had been treated with stimulant medications, suggesting that stimulants may reduce the symptoms of ADHD by reversing these volume reductions. In a second and related study, the investigators found that in patients with ADHD, emotional processing was normalized when patients were taking stimulant medications. Both studies point to possible mechanisms by which stimulants are effective; however, a significant limitation of these findings is that they were derived from cross-sectional studies.
In this current study, the investigators hope to replicate these treatment effects of stimulants in a prospective, controlled manner. The investigators plan to measure ADHD symptom severity in patients before and after 12-weeks of controlled treatment with either a stimulant medication or placebo while utilizing structural and functional MRI. Combining imaging with a randomized controlled trial will allow us to better assess the effects of stimulants on brain function and structure.
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 Lisdexamfetamine and the other 50 patients to placebo. The investigators will acquire high-resolution, anatomical and functional MRI images at baseline and after 12 weeks of treatment.
In addition, 75 age- and sex-matched healthy control subjects will be imaged at baseline.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
ADHD, Vyvanse, stimulant medication, ADD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two treatment arms plus sample of healthy controls, who were assessed at one time point
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychostimulant
Arm Type
Experimental
Arm Description
30-70 mg capsule of Lisdexamfetamine once daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
30-70 mg capsule of placebo (sugar pill) once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine
Other Intervention Name(s)
Vyvanse
Intervention Description
During the first 4 weeks of treatment, the dosage of Lisdexamfetamine will be adjusted based on the patient's response to the medication. The patient will then be maintained at the lowest effective dose for the remaining 8 weeks of treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Placebo dosing will parallel that of Lisdexamfetamine.
Primary Outcome Measure Information:
Title
Brain Structure Volume
Description
Brain structure volume measured in mm^3
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Posner, M.D
Organizational Affiliation
NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35141898
Citation
Wang Y, Kessel E, Lee S, Hong S, Raffanello E, Hulvershorn LA, Margolis A, Peterson BS, Posner J. Causal effects of psychostimulants on neural connectivity: a mechanistic, randomized clinical trial. J Child Psychol Psychiatry. 2022 Nov;63(11):1381-1391. doi: 10.1111/jcpp.13585. Epub 2022 Feb 9.
Results Reference
derived
Learn more about this trial
Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD
We'll reach out to this number within 24 hrs