Anorexia NervosaADOL_ANNCT00978666
Functional Magnetic Resonance Imaging (fMRI) Imaging Study in Adolescents With Anorexia Nervosa
An observational study of Anorexia Nervosa, run by University of California, San Diego at 1 site in United States.
Trial summary
The purpose of this study is to use fMRI imaging technology to examine areas in the brain related to appetite, reward and cognition in adolescent women with eating disorders as compared to those who have never had an eating disorder. Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Nov 2019
- 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 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Participants with anorexia nervosa will be selected from the community as well as from local medical clinics and eating disorder treatment centers. Healthy volunteers will be selected from the community at large.
Participants w/ Anorexia Inclusion Criteria
- Female
- Ages 12-18
- Right Handed
- Active AN diagnosis (within last 6 months), excluding amenorrhea criteria
- IBW 70-87% Exclusion Criteria
- Male
- Left Handed
- Does not meet AN criteria within last 6 months
- Alcohol/drug dependence in the 3 months prior to study
- Alcohol/drug use within the 30 days prior to scan. Tox Screen will be administered at GCRC.
- Use of antipsychotic medication in 3 months prior to study (SSRI OK)
- Current diagnosis of severe major effective d/o or anxiety d/o or other psychopathology that might interfere with ability to participate e.g requiring inpatient hospitalization or medication
- Pregnancy or lactation
- Organic brain syndromes, dementia, psychotic disorders or mental retardation
- Neurological or medical disorders such as seizure disorder, renal disease including pyelonephritis and chronic cystitis, impaired renal function including hyponatremia (less than 135meq/l), hypokalemia, raised BUN (more than 15mg/dl), diabetes, thyroid disease (hypo and hyper), EKG indicative of electrolyte imbalance
- Lack of effective birth control during 15 days before the scan. A Urine pregnancy test will be conducted within 24 hours of the scan
- Insufficient English
Healthy Volunteer Participants Inclusion criteria
- Female
- Ages 12-18
- Right Handed
- IBW between 90% and 120% Exclusion Criteria
- Male
- Left Handed
- Current or past psychiatric (definitive Axis I) disorder
- Alcohol/drug use within the 30 days prior to scan
- Pregnancy or lactation
- Organic brain syndromes, dementia, psychotic disorders or mental retardation
- Neurological or medical illness as indicated by lab tests, medical and psychiatric histories and physical examination
- Any stigmata suggestive of eating disorder
- Any first degree relatives with an Eating Disorder
- Any first degree relative with a current/past major psychiatric disorder (depression and alcoholism taken on a case by case basis and measured by severity)
- Insufficient English
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSD Eating Disorder Treatment and Research Program
La Jolla, California, 92037
About this study
Official title: Neural Dysfunction of Interoception in Adolescents Diagnosed With Anorexia Nervosa
The purpose of this study is to use fMRI imaging technology to examine areas in the brain related to appetite, reward and cognition in adolescent women with eating disorders as compared to those who have never had an eating disorder. Better understanding biologic vulnerabilities in women with anorexia is essential for developing more effective treatment options.
Read the detailed description
Individuals with anorexia nervosa (AN) have aberrant feeding behavior, disturbances of emotionality and impulse control, and have high rates of relapse after weight restoration (Carter et al., 2004; Halmi et al., 2003). There is no proven treatment that reverses symptoms. Although imaging studies in individuals recovered from AN (REC AN) suggest that these symptoms are related to dysfunction of the striatal, insular, and prefrontal areas, less is known about the biology of these core symptoms in currently ill individuals (ILL AN). This application will use blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) to examine neural substrates underlying appetitive, reward, and cognitive dysregulation in ill AN. We will study 22 adolescent women currently ill with AN and 22 healthy adolescent control women (CW), all of whom are 14 to 18 years old.
The specific aims of the project are:
AIM 1: The anterior insula (AI), orbitofrontal cortex (OFC), and associated regions integrate sensory/hedonic aspects of taste and interoceptive awareness in the service of homeostasis. We hypothesize that restricted eating and weight loss occur in AN because a palatable food elicits little reward.
AIM 2: Little in life is rewarding to individuals with AN aside from weight loss, and they tend to be overconcerned with future consequences. We predict that ill AN will show an inability to discriminate positive and negative feedback reflecting aberrant anterior ventral striatum (AVS) limbic function.
AIM 3: AN tend to be rigid, inflexible and behaviorally inhibited. We will use a stop task (Band et al., 2003; Logan et al., 1984; Matthews et al., 2005) to characterize the neural substrates of inhibitory motor control. We hypothesize that ill AN, relative to CW, will show a demand-specific alteration of a fronto-subthalamic circuit that is necessary for motor inhibition (Aron et al., 2004).
AIM 4: In an exploratory aim, we propose to examine how clinical, cognitive, and personality/temperament measures might be correlated to either the BOLD response and/or the integrity of frontostriatal connectivity as determined using diffusion tensor imaging (DTI).
Taken together, these aims will enable us to better characterize cognitive and limbic dysfunction in these populations. Understanding biologic vulnerabilities in AN is critical for developing effective treatment interventions for this often chronic and deadly disorder. In addition, there is a lack of understanding of appropriate methodologies necessary to address the unique problems inherent in the study of ill AN. Thus, this project will also characterize confounding factors, such as brain volume, energy metabolism, development stages, and gonadal steroids, with the intent that a future project will incorporate the methodology needed to rigorously investigate this population.
- Conditions
- Anorexia Nervosa
- Medical subject headings
- Anorexia Nervosa
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 |
|---|---|---|
| Healthy controls | Healthy comparison adolescent females | |
| Anorexia Nervosa | Adolescent females currently ill with Anorexia Nervosa, restricting type |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startJun 2009
- Primary completionAug 2011
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amanda Grethe, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978666
- Sponsor's protocol ID
- 090008
- Other IDs
- R21MH086017
- Acronym
- ADOL_AN
- Status last verified
- Nov 2019
- First submitted
- 16 Sep 2009
- Last updated
- 14 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Dysfunction of Interoception in Adolescents Diagnosed With Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT00978666
- Acronym / sponsor ID
- ADOL_AN / 090008
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2009 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 17 Sep 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.
The purpose of this study is to use fMRI imaging technology to examine areas in the brain related to appetite, reward and cognition in adolescent women with eating disorders as compared to those who have never had an eating disorder. Better understanding biologic vulnerabilities in women with anorexia is essential for developing more effective treatment options.
Detailed description
Individuals with anorexia nervosa (AN) have aberrant feeding behavior, disturbances of emotionality and impulse control, and have high rates of relapse after weight restoration (Carter et al., 2004; Halmi et al., 2003). There is no proven treatment that reverses symptoms. Although imaging studies in individuals recovered from AN (REC AN) suggest that these symptoms are related to dysfunction of the striatal, insular, and prefrontal areas, less is known about the biology of these core symptoms in currently ill individuals (ILL AN). This application will use blood oxygen level-dependent (BOLD) functional magnetic resonance imaging (fMRI) to examine neural substrates underlying appetitive, reward, and cognitive dysregulation in ill AN. We will study 22 adolescent women currently ill with AN and 22 healthy adolescent control women (CW), all of whom are 14 to 18 years old.
The specific aims of the project are:
AIM 1: The anterior insula (AI), orbitofrontal cortex (OFC), and associated regions integrate sensory/hedonic aspects of taste and interoceptive awareness in the service of homeostasis. We hypothesize that restricted eating and weight loss occur in AN because a palatable food elicits little reward.
AIM 2: Little in life is rewarding to individuals with AN aside from weight loss, and they tend to be overconcerned with future consequences. We predict that ill AN will show an inability to discriminate positive and negative feedback reflecting aberrant anterior ventral striatum (AVS) limbic function.
AIM 3: AN tend to be rigid, inflexible and behaviorally inhibited. We will use a stop task (Band et al., 2003; Logan et al., 1984; Matthews et al., 2005) to characterize the neural substrates of inhibitory motor control. We hypothesize that ill AN, relative to CW, will show a demand-specific alteration of a fronto-subthalamic circuit that is necessary for motor inhibition (Aron et al., 2004).
AIM 4: In an exploratory aim, we propose to examine how clinical, cognitive, and personality/temperament measures might be correlated to either the BOLD response and/or the integrity of frontostriatal connectivity as determined using diffusion tensor imaging (DTI).
Taken together, these aims will enable us to better characterize cognitive and limbic dysfunction in these populations. Understanding biologic vulnerabilities in AN is critical for developing effective treatment interventions for this often chronic and deadly disorder. In addition, there is a lack of understanding of appropriate methodologies necessary to address the unique problems inherent in the study of ill AN. Thus, this project will also characterize confounding factors, such as brain volume, energy metabolism, development stages, and gonadal steroids, with the intent that a future project will incorporate the methodology needed to rigorously investigate this population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy controls | – | –Healthy comparison adolescent females |
| Anorexia Nervosa | – | –Adolescent females currently ill with Anorexia Nervosa, restricting type |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants with anorexia nervosa will be selected from the community as well as from local medical clinics and eating disorder treatment centers. Healthy volunteers will be selected from the community at large.
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
Not reported in the source record.
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 14 Nov 2019.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by University of California, San Diego 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?
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 14 Nov 2019. 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.
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 14 Nov 2019.