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OpenTrials
Completed

NCT Number: NCT01404273

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

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).

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benson-Henry Institute, 151 Merrimac St, 4th Floor

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female adults (ages 18 - 49).
  • 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

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

Treatment and study plan

Meditation/Relaxation Response Training

Behavioral

1 hour weekly sessions with 20 min daily home practice for 6 weeks

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Centers for Disease Control and Prevention

Registry information

Official study title

Functional MRI of an Open Trial of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder

Acronym: ADHD

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2011
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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