Examining Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD): An fMRI Study
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Purpose
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 | Intervention |
|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Lisdexamfetamine Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Examining Emotional Lability in Patients With ADHD |
- Emotional lability as determined by fMRI signal [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | August 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Psychostimulant |
Drug: Lisdexamfetamine
Lisdexamfetamine dose will range between 30-70mg daily and will be titrated according to treatment response.
|
| Placebo Comparator: Placebo |
Drug: Placebo
Placebo dosing will parallel that of the active treatment
|
Detailed Description:
A cohort of 50 patients with ADHD will be recruited for a 12 week, double-blind, parallel, randomized controlled trial of Lisdexamfetamine (LDEX) versus placebo, with 25 patients randomized to LDEX and the other 25 to placebo. In addition, 25 age- and sex-matched healthy control subjects will be imaged at baseline and 12 weeks later. The investigators will acquire high-resolution, anatomical images and functional MRI images at baseline and after 12 weeks of treatment.
Eligibility| Ages Eligible for Study: | 6 Years to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
ADHD Participants: 1. The subject satisfies DSM-IV-TR criteria for a primary diagnosis of ADHD - Combined Type and is between 6 - 25 years of age.
Healthy Control Participants: 1. No active Axis I or II psychiatric disorder.
All Participants:
- The subject is male or female 6 - 25 years of age and in good physical health.
- Adult subjects must provide signature of their informed consent at the onset of screening.Adolescent subjects must provide assent and a legal guardian must provide consent.
- Females of child-bearing potential must have a negative urine pregnancy test and must be using adequate contraception.
Exclusion Criteria:
- The subject has a comorbid Axis I psychiatric diagnosis or other symptomatic manifestations that, in the opinion of the examining physician, will contraindicate Lisdexamfetamine treatment or confound safety assessments.
- The subject meets DSM-IV-TR criteria for active substance abuse and/or dependence.
- The subject has any lifetime history of cocaine or stimulant abuse or dependence.
- The subject is currently doing well on a stimulant.
- The subject has had prior treatment with psychostimulants of > 1 month duration and/or b)has had treatment with psychostimulants within the past 4 months.
- The subject has a history of seizure (exclusive of febrile seizure), a tic disorder, or a history of Tourette syndrome.
- The subject has a documented allergy or intolerance to Lisdexamphetamine products.
- The subject has a diagnosis of hyperthyroidism, glaucoma, or a history of cardiovascular disease(including tachycardia and hypertension), or any other serious medical illness.
- Patients with a medical condition or family history that may interfere with study participation and/or study assessments, or for which treatment with Lisdexamphetamine may pose a risk to the patient.This will include any medical condition or family history of cardiovascular disease.
- The subject is taking other medications that have central nervous system effects.
- The subject is pregnant or lactating.
- Personal or family history of cardiac disease that contraindicates treatment with a psychostimulant.
- The subject is actively suicidal.
- MRI contraindications (e.g. irremovable metal on the body, pacemaker, braces, etc.)
Contacts and Locations| Contact: Jonathan Posner, M.D | 212-543-2533 | posnerj@nyspi.columbia.edu |
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10706 | |
| Contact: Jonathan Posner, MD 212-543-2533 | |
| Principal Investigator: Jonathan Posner, MD | |
| NYSPI | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Jonathan Posner, MD 212-543-2533 | |
| Principal Investigator: | Jonathan Posner, M.D | NYSPI |
More Information
Additional Information:
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT01415440 History of Changes |
| Other Study ID Numbers: | 6235 |
| Study First Received: | July 26, 2011 |
| Last Updated: | October 24, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
ADHD Vyvanse stimulant medication |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Dextroamphetamine |
Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013