Anorexia NervosaNCT03275545
Neural Correlates of Reward and Symptom Expression in Anorexia Nervosa
An observational study of Anorexia Nervosa, run by University of Minnesota at 1 site in United States.
Trial summary
The objective of this study is to identify the patterns of brain activity in reward circuitry that promote symptoms of anorexia nervosa. This project will compare weight-restored individuals with anorexia nervosa to a non-eating disorder control group on reward brain circuitry patterns in response to typically… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Feb 2018to 1 Aug 2022
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Many participants will be community individuals self-referred to participate through a flyer or other study advertisement. Individuals who are patients at The Emily Program eating disorder treatment facility who are in the process of weight-restoration or who have recently been weight-restored from anorexia nervosa may also be presented with a flyer by clinical staff at the program through the process outlined above. Participants will also be recruited from logs of individuals who had previously participated in studies in our lab and stated that they would like to be contacted for future studies and our active recruitment log.
Who may be able to join
- Age > 18 years old
- Current BMI > 18.5 kg/m2
- Ability to read and speak in English
- Right-handed
- Weight restored Anorexia Nervosa group: 1) DSM-5 diagnosis of AN in the past 6 months, with the exception of body image disturbance and intense fear of weight gain criteria; 2) BMI < 18.5 kg/m2 within past 6 months
Who cannot join
- Medical instability or current pregnancy
- Current substance use disorder, psychosis, or bipolar-I disorder
- Contraindication for fMRI
- History of neurological disorder/injury (e.g., stroke; head injury with > 10 minutes loss of consciousness)
- Food allergy that cannot be accommodated through substitutions to the laboratory test meal
- Lacking capacity to consent
- Non-eating disorder Control group: Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
The objective of this study is to identify the patterns of brain activity in reward circuitry that promote symptoms of anorexia nervosa. This project will compare weight-restored individuals with anorexia nervosa to a non-eating disorder control group on reward brain circuitry patterns in response to typically rewarding cues (i.e., entertaining videos) and disorder-specific restrictive eating cues (i.e., low-fat food choice) using fMRI. In addition, this study will examine which neurobiological reward responses among weight-restored individuals with anorexia nervosa predict objective restrictive eating (measured by laboratory meal intake) and longitudinal risk of relapse one year later.
Read the detailed description
Aim 1: To compare patterns of brain activity in reward circuits to typically rewarding cues and disorder-specific cues between weight-restored individuals with anorexia nervosa and non-eating disorder controls
Hypothesis 1a: Activity in reward circuitry will be elevated in response to typically rewarding cues in the non-eating disorder control group versus weight-restored anorexia nervosa group.
Hypothesis 1b: Activity in reward circuitry will be elevated in response to disorder-specific in the weight-restored anorexia nervosa group versus the non-eating disorder control group.
Aim 2: To specify the relationship between brain patterns related to reward and restrictive eating among weight-restored individuals with anorexia nervosa
Hypothesis 2a: Lower reward circuit activity in response to typically rewarding cues will predict lower test meal intake for weight-restored anorexia nervosa group versus the non-eating disorder control group.
Hypothesis 2b: Higher reward circuit activity in response to disorder-specific cues will predict lower test meal intake for the weight-restored anorexia nervosa group versus the non-eating disorder control group.
Aim 3: To identify the brain patterns in reward circuitry associated with the risk of relapse among weight-restored individuals with anorexia nervosa in the year following weight-restoration.
Hypothesis 3a: Lower reward circuit activity in response to typically rewarding cues will predict relapse in the weight-restored anorexia nervosa group.
Hypothesis 3b: Higher reward circuit activity in response to disorder-specific cues will predict relapse in the weight-restored anorexia nervosa group.
- Conditions
- Anorexia Nervosa
- Being tested
- No intervention
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention is being examined in this study
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa, Weight Restored | Individuals with a recent diagnosis of anorexia nervosa (within the past 6 months), who currently have their weight in a healthy range (BMI > or = 18.5 kg/m2) Receives: Other: No intervention | |
| Non-eating disorder Control | Individuals without a history of an eating disorder and no current DSM-5 psychiatric diagnoses. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain activation in reward circuits
Activation in regions of interest in reward brain circuitry (i.e., ventral tegmental area, nucleus accumbens) in response to typically-rewarding and disorder-specific tasks
Measured: Baseline
Secondary outcomes (2)
Restrictive eating
Caloric consumption from a laboratory test meal
Measured: Baseline
Relapse
Relapse from anorexia nervosa, defined as: BMI < 18.5 kg/m2 and/or binge eating and/or purging > 1x/week for 3 consecutive months
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start28 Feb 2018
- Primary completion12 Jul 2022
- Study completion1 Aug 2022
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 MinnesotaThe 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
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Haynos, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275545
- Sponsor's protocol ID
- PSYCH-2017-25878
- Status last verified
- Sep 2022
- First submitted
- 5 Sep 2017
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Reward and Symptom Expression in Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT03275545
- Acronym / sponsor ID
- PSYCH-2017-25878
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 28 Feb 2018 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 7 Sep 2017 (actual)
- 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 objective of this study is to identify the patterns of brain activity in reward circuitry that promote symptoms of anorexia nervosa. This project will compare weight-restored individuals with anorexia nervosa to a non-eating disorder control group on reward brain circuitry patterns in response to typically rewarding cues (i.e., entertaining videos) and disorder-specific restrictive eating cues (i.e., low-fat food choice) using fMRI. In addition, this study will examine which neurobiological reward responses among weight-restored individuals with anorexia nervosa predict objective restrictive eating (measured by laboratory meal intake) and longitudinal risk of relapse one year later.
Detailed description
Aim 1: To compare patterns of brain activity in reward circuits to typically rewarding cues and disorder-specific cues between weight-restored individuals with anorexia nervosa and non-eating disorder controls
Hypothesis 1a: Activity in reward circuitry will be elevated in response to typically rewarding cues in the non-eating disorder control group versus weight-restored anorexia nervosa group.
Hypothesis 1b: Activity in reward circuitry will be elevated in response to disorder-specific in the weight-restored anorexia nervosa group versus the non-eating disorder control group.
Aim 2: To specify the relationship between brain patterns related to reward and restrictive eating among weight-restored individuals with anorexia nervosa
Hypothesis 2a: Lower reward circuit activity in response to typically rewarding cues will predict lower test meal intake for weight-restored anorexia nervosa group versus the non-eating disorder control group.
Hypothesis 2b: Higher reward circuit activity in response to disorder-specific cues will predict lower test meal intake for the weight-restored anorexia nervosa group versus the non-eating disorder control group.
Aim 3: To identify the brain patterns in reward circuitry associated with the risk of relapse among weight-restored individuals with anorexia nervosa in the year following weight-restoration.
Hypothesis 3a: Lower reward circuit activity in response to typically rewarding cues will predict relapse in the weight-restored anorexia nervosa group.
Hypothesis 3b: Higher reward circuit activity in response to disorder-specific cues will predict relapse in the weight-restored anorexia nervosa group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa, Weight Restored | – | Other: No interventionIndividuals with a recent diagnosis of anorexia nervosa (within the past 6 months), who currently have their weight in a healthy range (BMI > or = 18.5 kg/m2) |
| Non-eating disorder Control | – | Other: No interventionIndividuals without a history of an eating disorder and no current DSM-5 psychiatric diagnoses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Many participants will be community individuals self-referred to participate through a flyer or other study advertisement. Individuals who are patients at The Emily Program eating disorder treatment facility who are in the process of weight-restoration or who have recently been weight-restored from anorexia nervosa may also be presented with a flyer by clinical staff at the program through the process outlined above. Participants will also be recruited from logs of individuals who had previously participated in studies in our lab and stated that they would like to be contacted for future studies and our active recruitment log.
Key inclusion criteria (5 listed)
- Age > 18 years old
- Current BMI > 18.5 kg/m2
- Ability to read and speak in English
- Right-handed
- Weight restored Anorexia Nervosa group: 1) DSM-5 diagnosis of AN in the past 6 months, with the exception of body image disturbance and intense fear of weight gain criteria; 2) BMI < 18.5 kg/m2 within past 6 months
Key exclusion criteria (7 listed)
- Medical instability or current pregnancy
- Current substance use disorder, psychosis, or bipolar-I disorder
- Contraindication for fMRI
- History of neurological disorder/injury (e.g., stroke; head injury with > 10 minutes loss of consciousness)
- Food allergy that cannot be accommodated through substitutions to the laboratory test meal
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 |
|---|---|---|
| No interventionNo intervention is being examined in this study | Other | Anorexia Nervosa, Weight Restored, Non-eating disorder Control |
Primary outcome
Brain activation in reward circuits
Time frame: Baseline
Activation in regions of interest in reward brain circuitry (i.e., ventral tegmental area, nucleus accumbens) in response to typically-rewarding and disorder-specific tasks
2 secondary outcomes
Restrictive eating
Time frame: Baseline
Relapse
Time frame: 12 months
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 21 Sep 2022.
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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.
Ann Haynos, PhD principal investigator
University of Minnesota
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 Minnesota 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 5 inclusion and 7 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 21 Sep 2022. 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?
Brain activation in reward circuits (time frame: Baseline). 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 21 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.