ADHDPhase 4NCT01858064
Predicting Treatment Response to Stimulants in Adult ADHD Using Functional Magnetic Resonance Imaging
A Phase 4 study testing OROS-MPH in people with ADHD, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The primary aim of this study is to assess the predictability of treatment response to stimulants in adults with ADHD using functional magnetic resonance This study will be a six-week, open-label study including adults ranging from age 18-55 with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- ADHD
- What is being tested?
- OROS-MPH
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Apr 2015
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female adults ages 18-55 years
- Right handed
- A diagnosis current of childhood onset ADHD, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment
- A score of > 20 on the Adult ADHD Investigator Symptom Report Scale (AISRS) or a CGI-Severity score of > 4 (moderate severity)
Who cannot join
- A history of non-response or intolerance to stimulants at adequate doses as determined by the clinician
- Pregnant or nursing females
- Serious, unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease
- Glaucoma
- Clinically unstable psychiatric conditions including suicidality, homocidality, bipolar disorder, psychosis, or lifetime history of a clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis
- Tics or diagnosis of Tourette's syndrome
Show all 11Show fewer
- Current (within 3 months) DSM-IV criteria for abuse or dependence with any psychoactive substance other than nicotine
- Current use of psychotropic medications
- Current use of MAO Inhibitor or use within the past two weeks
- Claustrophobia or an standard contraindications to MRI scanning (metal in body)
- Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent or grandchild
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
The primary aim of this study is to assess the predictability of treatment response to stimulants in adults with ADHD using functional magnetic resonance
This study will be a six-week, open-label study including adults ranging from age 18-55 with ADHD.
Read the detailed description
Certain brain characteristics have been identified in individuals with persistent and remitted ADHD. We predict that neural functional connectivity; specifically decreases in connectivity between the posterior cingulated cortex and medial prefrontal cortex, as well as decreases in anticorrelations between the medial prefrontal cortex and dorsolateral prefrontal cortex, will predict greater response to stimulant treatment.
- Conditions
- ADHD
- Being tested
- OROS-MPH
- Keywords
- ADHD, OROS-MPH, Adults, Functional Magnetic Resonance Imaging
- 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.
OROS-MPHDrug
Capsule administered daily, beginning at 36 mg/day and titrated on a weekly basis for 3 weeks in increments of 18-36 mg/day to a maximum daily dose of 90 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| OROS-MPH | Experimental | OROS-MPH is administered in capsule form daily, beginning at 36 mg/day and titrated on a weekly basis for 3 weeks in increments of 18-36 mg/day to a maximum daily dose of 90mg/day. Receives: Drug: OROS-MPH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult Investigator Rating Scale
AISRS
Measured: Baseline to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2013 (estimated)
- Study startApr 2015
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: Competing Departmental Studies
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas J. Spencer, MD, Massachusetts General Hospital
- Investigators
- Thomas Spencer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858064
- Sponsor's protocol ID
- 2013000956
- Status last verified
- Apr 2015
- First submitted
- 16 May 2013
- Last updated
- 28 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicting Treatment Response to Stimulants in Adult ADHD Using Functional Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01858064
- Acronym / sponsor ID
- 2013000956
- Conditions
- ADHD
- Keywords
- ADHD, OROS-MPH, Adults, Functional Magnetic Resonance Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Competing Departmental Studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 20 May 2013 (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.
The primary aim of this study is to assess the predictability of treatment response to stimulants in adults with ADHD using functional magnetic resonance
This study will be a six-week, open-label study including adults ranging from age 18-55 with ADHD.
Detailed description
Certain brain characteristics have been identified in individuals with persistent and remitted ADHD. We predict that neural functional connectivity; specifically decreases in connectivity between the posterior cingulated cortex and medial prefrontal cortex, as well as decreases in anticorrelations between the medial prefrontal cortex and dorsolateral prefrontal cortex, will predict greater response to stimulant treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OROS-MPH | Experimental | Drug: OROS-MPHOROS-MPH is administered in capsule form daily, beginning at 36 mg/day and titrated on a weekly basis for 3 weeks in increments of 18-36 mg/day to a maximum daily dose of 90mg/day. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male or female adults ages 18-55 years
- Right handed
- A diagnosis current of childhood onset ADHD, according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) based on clinical assessment
- A score of > 20 on the Adult ADHD Investigator Symptom Report Scale (AISRS) or a CGI-Severity score of > 4 (moderate severity)
Key exclusion criteria (11 listed)
- A history of non-response or intolerance to stimulants at adequate doses as determined by the clinician
- Pregnant or nursing females
- Serious, unstable medical illnesses including hepatic, renal, gastroenterological, respiratory, cardiovascular, endocrinologic (thyroid), neurologic (seizure), immunologic, or hematologic disease
- Glaucoma
- Clinically unstable psychiatric conditions including suicidality, homocidality, bipolar disorder, psychosis, or lifetime history of a clinically serious condition potentially exacerbated by a stimulant, such as mania or psychosis
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 |
|---|---|---|
| OROS-MPHCapsule administered daily, beginning at 36 mg/day and titrated on a weekly basis for 3 weeks in increments of 18-36 mg/day to a maximum daily dose of 90 mg/day. | Drug | OROS-MPH |
Primary outcome
Adult Investigator Rating Scale
Time frame: Baseline to 6 weeks
AISRS
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2015.
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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.
Thomas Spencer, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OROS-MPH 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 4 inclusion and 11 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: withdrawn, as of the sponsor's last update on 28 Apr 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Adult Investigator Rating Scale (time frame: Baseline to 6 weeks). 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 28 Apr 2015.