ADHDADHDNCT01404273
Functional MRI of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
A study testing Meditation/Relaxation Response Training in people with ADHD, run by Massachusetts General Hospital at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- ADHD
- What is being tested?
- Meditation/Relaxation Response Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Benson-Henry Institute, 151 Merrimac St, 4th Floor
Boston, Massachusetts, 02114
About this study
Official title: Functional MRI of an Open Trial 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).
- Conditions
- ADHD
- Being tested
- Meditation/Relaxation Response Training
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation/Relaxation Response TrainingBehavioural
1 hour weekly sessions with 20 min daily home practice for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Meditation/Relaxation Response Training | Experimental | Not described Receives: Behavioral: Meditation/Relaxation Response Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 sessions, 2 hours each to be conducted before and after the 6-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2011 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, George Bush, Massachusetts General Hospital
- Investigators
- George Bush, M.D., Principal investigator, MGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01404273
- Sponsor's protocol ID
- 2009P002052
- Acronym
- ADHD
- Status last verified
- Jul 2013
- First submitted
- 25 Jul 2011
- Last updated
- 31 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional MRI of an Open Trial of Relaxation Response Training in Adults With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01404273
- Acronym / sponsor ID
- ADHD / 2009P002052
- Conditions
- ADHD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 28 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Meditation/Relaxation Response Training | Experimental | Behavioral: Meditation/Relaxation Response Training |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meditation/Relaxation Response Training1 hour weekly sessions with 20 min daily home practice for 6 weeks | Behavioural | Meditation/Relaxation Response Training |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Bush, M.D. principal investigator
MGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meditation/Relaxation Response Training in people with ADHD, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2013.