Imaging the Effects of Stimulant Medication on Emotional Lability in Patients With ADHD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01415440|
Recruitment Status : Recruiting
First Posted : August 12, 2011
Last Update Posted : June 27, 2017
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.
|Condition or disease||Intervention/treatment|
|Attention Deficit Hyperactivity Disorder||Drug: Lisdexamfetamine Drug: Placebo|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Examining the Effects of Stimulant Medication on Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||February 2018|
30-70 mg capsule of Lisdexamfetamine once daily for 12 weeks
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.
Other Name: Vyvanse
Placebo Comparator: Placebo
30-70 mg capsule of placebo (sugar pill) once daily for 12 weeks
Placebo dosing will parallel that of Lisdexamfetamine.
Other Name: Sugar pill
- Changes in brain structure and function produced by stimulant medications in patients with ADHD [ Time Frame: 12 weeks ]This will be assessed using MRI, diagnostic interviews, behavior rating scales, and computer tasks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01415440
|Contact: Jonathan Posner, M.Dfirstname.lastname@example.org|
|United States, New York|
|New York State Psychiatric Institute||Recruiting|
|New York, New York, United States, 10032|
|Contact: Jonathan Posner, MD 646-774-5735 email@example.com|
|Principal Investigator: Jonathan Posner, MD|
|Sub-Investigator: Laurence Greenhill, MD|
|Principal Investigator:||Jonathan Posner, M.D||NYSPI|