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Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01404273
First Posted: July 28, 2011
Last Update Posted: July 31, 2013
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. Read our disclaimer for details.
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
George Bush, Massachusetts General Hospital
  Purpose
This research study is being done to examine how meditation and the relaxation response (RR) may change brain activity in attention-deficit/hyperactivity disorder (ADHD).

Condition Intervention
ADHD Behavioral: Meditation/Relaxation Response Training

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Functional MRI of an Open Trial of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder

Resource links provided by NLM:


Further study details as provided by George Bush, Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in functional magnetic resonance imaging (fMRI) activation from baseline after a 6-week intervention [ Time Frame: 2 sessions, 2 hours each to be conducted before and after the 6-week intervention ]
    functional magnetic resonance imaging (fMRI) activation in dorsal anterior medial cingulate cortex (daMCC) & dorsolateral prefrontal cortex (DLPFC) during multi-source interference task (MSIT)


Enrollment: 12
Study Start Date: September 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meditation/Relaxation Response Training Behavioral: Meditation/Relaxation Response Training
1 hour weekly sessions with 20 min daily home practice for 6 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female adults (ages 18 - 49).
  2. Patients with the diagnosis of Attention Deficit Hyperactivity Disorder (ADHD), by the Diagnostic and Statistics Manual of Mental Disorders (DSM-IV), as manifested in clinical evaluation and confirmed by structured interview.

Exclusion Criteria:

  1. Any current, non-ADHD Axis I psychiatric conditions
  2. Baseline Beck Depression Inventory (BDI) > 19.
  3. Any clinically significant chronic medical condition.
  4. Mental retardation
  5. Organic brain disorders
  6. Seizures or tics.
  7. Pregnant or nursing females.
  8. Clinically unstable psychiatric conditions (suicidal behaviors, psychosis).
  9. Current or recent (within the past 2 years) substance abuse or dependence.
  10. Patients currently or recently (within past 1 month) on psychotropic medication.
  11. Subjects with current or prior adequate psychopharmacologic treatment for ADHD.
  12. Regular practice of an Relaxation Response-inducing technique within the past year
  13. History of claustrophobia or any of the standard contraindications to magnetic resonance imaging (MRI) scanning(metal objects within body).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404273


Locations
United States, Massachusetts
Benson-Henry Institute, 151 Merrimac St, 4th Floor
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Centers for Disease Control and Prevention
Investigators
Principal Investigator: George Bush, M.D. MGH
  More Information

Responsible Party: George Bush, Director of Neuroimaging Research, Benson-Henry Institute for Mind-Body Medicine at MGH, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01404273     History of Changes
Other Study ID Numbers: 2009P002052
First Submitted: July 25, 2011
First Posted: July 28, 2011
Last Update Posted: July 31, 2013
Last Verified: July 2013

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders