Bulimia NervosaNCT00916071
Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders
An observational study of Bulimia Nervosa and Eating Disorders, run by Massachusetts General Hospital.
Trial summary
To understand whether a relationship exists between eating disorders and ADHD, we seek to clarify the prevalence of ADHD in individuals with eating disorders. To this end, we will estimate the prevalence of ADHD, and other neuropsychiatric disorders, in outpatients with history of an eating disorder diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bulimia Nervosa, Eating Disorders, ADHD
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Oct 2008to Feb 2010
- Phase
- Observational
- 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
Study population: Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis.
Who may be able to join
- Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis.
Who cannot join
- Any clinically unstable psychiatric conditions such as: acute psychosis, acute panic, acute obsessive compulsive disorder, acute mania, acute suicidality, acute substance use disorders (alcohol or drugs), and sociopathy.
- Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease that would confound ability to participate in valid assessments.
- Mental retardation (IQ <75).
- Organic brain disorders.
- Non-English speaking subjects will not be allowed into the study because the assessment instruments are unavailable and have not been adequately standardized in other languages.
About this study
To understand whether a relationship exists between eating disorders and ADHD, we seek to clarify the prevalence of ADHD in individuals with eating disorders. To this end, we will estimate the prevalence of ADHD, and other neuropsychiatric disorders, in outpatients with history of an eating disorder diagnosis. Secondarily, we will identify patterns of cognitive deficits in outpatients with history of an eating disorder diagnosis. We will also examine whether ADHD in this population is associated with functional and familial correlates associated with ADHD.
- Conditions
- Bulimia Nervosa, Eating Disorders, ADHD
- Keywords
- Bulimia Nervosa, Eating Disorder NOS, Attention Deficit Hyperactivity Disorder, ADHD
- Medical subject headings
- Bulimia Nervosa, Feeding and Eating Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Eating Disorders | Study subjects will be individuals with a history of eating disorder(s) diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will identify the lifetime rate of mental health conditions using structured clinical interviews in subjects with a lifetime history of eating disorders and compare the rate of these conditions to that of non-ED control subjects.
Measured: 1 time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startOct 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Hilda and Preston Davis Foundation
- Responsible party
- Principal investigator, Craig B. Surman, MD, Massachusetts General Hospital
- Investigators
- Craig Surman, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916071
- Sponsor's protocol ID
- 2007-P-002374
- Status last verified
- Jan 2013
- First submitted
- 5 Jun 2009
- Last updated
- 8 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders
- ClinicalTrials.gov ID
- NCT00916071
- Acronym / sponsor ID
- 2007-P-002374
- Conditions
- Bulimia Nervosa, Eating Disorders, ADHD
- Keywords
- Bulimia Nervosa, Eating Disorder NOS, Attention Deficit Hyperactivity Disorder, ADHD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- The Hilda and Preston Davis Foundation
- Study start
- Oct 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 9 Jun 2009 (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.
To understand whether a relationship exists between eating disorders and ADHD, we seek to clarify the prevalence of ADHD in individuals with eating disorders. To this end, we will estimate the prevalence of ADHD, and other neuropsychiatric disorders, in outpatients with history of an eating disorder diagnosis. Secondarily, we will identify patterns of cognitive deficits in outpatients with history of an eating disorder diagnosis. We will also examine whether ADHD in this population is associated with functional and familial correlates associated with ADHD.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eating Disorders | – | –Study subjects will be individuals with a history of eating disorder(s) diagnosis |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis.
Key inclusion criteria (1 listed)
- Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis.
Key exclusion criteria (5 listed)
- Any clinically unstable psychiatric conditions such as: acute psychosis, acute panic, acute obsessive compulsive disorder, acute mania, acute suicidality, acute substance use disorders (alcohol or drugs), and sociopathy.
- Any metabolic, neurological, hepatic, renal, cardiovascular, hematological, opthalmic, or endocrine disease that would confound ability to participate in valid assessments.
- Mental retardation (IQ <75).
- Organic brain disorders.
- Non-English speaking subjects will not be allowed into the study because the assessment instruments are unavailable and have not been adequately standardized in other languages.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
We will identify the lifetime rate of mental health conditions using structured clinical interviews in subjects with a lifetime history of eating disorders and compare the rate of these conditions to that of non-ED control subjects.
Time frame: 1 time
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 8 Mar 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.
Craig Surman, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Bulimia Nervosa and Eating Disorders, run by Massachusetts General Hospital.
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 1 inclusion and 5 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 8 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
We will identify the lifetime rate of mental health conditions using structured clinical interviews in subjects with a lifetime history of eating disorders and compare the rate of these conditions to that of non-ED control subjects. (time frame: 1 time). 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 8 Mar 2013.