Examining Emotional Lability in Patients With Attention Deficit Hyperactivity Disorder (ADHD): An fMRI Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by New York State Psychiatric Institute
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01415440
First received: July 26, 2011
Last updated: September 25, 2013
Last verified: October 2012
  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

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • 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: March 2014
Estimated Primary Completion Date: March 2014 (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
Criteria

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:

  1. The subject is male or female 6 - 25 years of age and in good physical health.
  2. 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.
  3. Females of child-bearing potential must have a negative urine pregnancy test and must be using adequate contraception.

Exclusion Criteria:

  1. 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.
  2. The subject meets DSM-IV-TR criteria for active substance abuse and/or dependence.
  3. The subject has any lifetime history of cocaine or stimulant abuse or dependence.
  4. The subject is currently doing well on a stimulant.
  5. 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.
  6. The subject has a history of seizure (exclusive of febrile seizure), a tic disorder, or a history of Tourette syndrome.
  7. The subject has a documented allergy or intolerance to Lisdexamphetamine products.
  8. The subject has a diagnosis of hyperthyroidism, glaucoma, or a history of cardiovascular disease(including tachycardia and hypertension), or any other serious medical illness.
  9. 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.
  10. The subject is taking other medications that have central nervous system effects.
  11. The subject is pregnant or lactating.
  12. Personal or family history of cardiac disease that contraindicates treatment with a psychostimulant.
  13. The subject is actively suicidal.
  14. MRI contraindications (e.g. irremovable metal on the body, pacemaker, braces, etc.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415440

Contacts
Contact: Jonathan Posner, M.D 212-543-2533 posnerj@nyspi.columbia.edu

Locations
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      
Sponsors and Collaborators
New York State Psychiatric Institute
Shire
Investigators
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: September 25, 2013
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 July 22, 2014