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

ADHD Clinical Trial

— ADHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404273
• Other study ID #: 2009P002052
• Status: Completed
• Phase: N/A
• First received: July 25, 2011
• Last updated: July 29, 2013
• Start date: September 2009
• Est. completion date: September 2011

Study information

• Verified date: July 2013
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• Meditation/Relaxation Response Training
1 hour weekly sessions with 20 min daily home practice for 6 weeks

Locations

Country	Name	City	State
United States	Benson-Henry Institute, 151 Merrimac St, 4th Floor	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Centers for Disease Control and Prevention

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in functional magnetic resonance imaging (fMRI) activation from baseline after a 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)	2 sessions, 2 hours each to be conducted before and after the 6-week intervention	No