- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00916071
Association Between Attention Deficit Hyperactivity Disorder and Bulimia Nervosa in Outpatients With Eating Disorders
March 7, 2013 updated by: Craig B. Surman, MD, Massachusetts General Hospital
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
64
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis.
Description
Inclusion Criteria:
- Male and female outpatients between, and including, 18 and 55 years of age with a history of eating disorder diagnosis.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
|
Eating Disorders
Study subjects will be individuals with a history of eating disorder(s) diagnosis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
1 time
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Craig Surman, MD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
February 1, 2010
Study Registration Dates
First Submitted
June 5, 2009
First Submitted That Met QC Criteria
June 5, 2009
First Posted (Estimate)
June 9, 2009
Study Record Updates
Last Update Posted (Estimate)
March 8, 2013
Last Update Submitted That Met QC Criteria
March 7, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Pathologic Processes
- Nervous System Diseases
- Neurologic Manifestations
- Signs and Symptoms, Digestive
- Dyskinesias
- Hyperphagia
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Disease
- Bulimia
- Feeding and Eating Disorders
- Attention Deficit Disorder with Hyperactivity
- Bulimia Nervosa
- Hyperkinesis
Other Study ID Numbers
- 2007-P-002374
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bulimia Nervosa
-
University of California, San DiegoActive, not recruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
-
Istituto Auxologico ItalianoCatholic University of the Sacred Heart; University of Turin, Italy; Open University and other collaboratorsRecruitingAnorexia Nervosa/BulimiaItaly
-
University Hospital, ToulouseUnknownAnorexia Nervosa/BulimiaFrance
-
Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... and other collaboratorsRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa (Other Specified Eating Disorder) | Atypical Bulimia Nervosa (Other Specified Eating Disorder)Netherlands
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia NervosaUnited States
-
University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia NervosaUnited States
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
-
Rosemary Claire RodenChildren's Miracle NetworkTerminatedBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
-
Yeshiva UniversityYale UniversityCompletedAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
-
Centre Hospitalier EsquirolNot yet recruitingAnorexia Nervosa | Hyperphagia | Eating Disorders | Boulimia NervosaFrance