NCT01882023

Brief Summary

Currently, there is not a robust, testable neural model available that sufficiently explains the development and maintenance of anorexia nervosa (AN) a severe, often fatal, adolescent-onset eating disorder. Using state of the art neuroimaging and neuropsychological techniques, our objective is to identify neural mechanisms in the adolescent brain underlying AN. This is of high clinical relevance in as much as it will provide a robust platform for a diagnostic battery so that physicians can identify those who are prone to develop AN at a very early stage of life. The aim of this research plan is: 1) To develop knowledge of cognitive dysfunction in adolescents who have recently been diagnosed with AN, with a battery of cognitive tests during a series of clinical visits. 2) To provide a scientific basis for our knowledge about how the brain of an adolescent with an eating disorder differs from that of a healthy adolescent, by conducting functional and structural magnetic resonance imaging on adolescent females with AN.

Trial Health

53
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
68mo left

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
May 2011Dec 2031

Study Start

First participant enrolled

May 1, 2011

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
17.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2031

Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

19.6 years

First QC Date

May 21, 2013

Last Update Submit

April 29, 2026

Conditions

Keywords

EDNOSadolescentseating disorderanorexia nervosa

Outcome Measures

Primary Outcomes (1)

  • Measure functional differences in adolescents with eating disorders and healthy controls.

    The analysis of each groups' neural activity will be carried out with statistical parametric mapping (SPM) implemented in Matlab. This will compare the statistical parametric maps between the group using ANOVAs, ANCOVAs and t-tests.

    This is measured during scanning shortly after patient admittance to treatment, and one year later. Controls have their scans shortly after being recruited to the study, then again 1 year later.

Secondary Outcomes (3)

  • Measure structural differences in adolescents with eating disorders and healthy controls.

    This is measured during scanning shortly after patient admittance to treatment, and one year later. Controls have their scans shortly after being recruited to the study, then again 1 year later.

  • Develop knowledge of cognitive dysfunction in adolescents with eating disorders.

    The cognitive measures are conducted shortly after recruitment of the study. The subjects are given the questionnaires upon their first meeting, and are posted back to us shortly after.

  • To examine whether clinical variables can predict neural activity.

    The neural activity is measured during scanning shortly after subject recruitment, and one year later. The clinical measurements are measured with questionnaires given to them on their first meeting after recruitment, which are later posted back to us.

Study Arms (2)

Eating disorder

Patients currently in treatment for eating disorders.

Healthy Controls

Age- and gender matched healthy controls.

Eligibility Criteria

Age13 Years - 18 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Half of the cohort are patients recruited from the eating disorder clinic. All subjects in the study are adolescent females residing in the Uppsala area.

You may qualify if:

  • Females
  • Age 13 - 18 yrs
  • Right handed
  • For controls: BMI within the "normal" range
  • For patients: Be admitted to treatment for an eating disorder

You may not qualify if:

  • On medication
  • Suffering from any other illnesses
  • Left handed
  • Metal implants which can impact the fMRI image
  • Severe claustrophobia
  • Pregnancy
  • Smoker
  • Regular alcohol drinker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Röntgenavdelningen, Uppsala Academic Hospital

Uppsala, Uppsala County, 751 24, Sweden

Location

Related Publications (15)

  • Brooks SJ, O'Daly OG, Uher R, Schioth HB, Treasure J, Campbell IC. Subliminal food images compromise superior working memory performance in women with restricting anorexia nervosa. Conscious Cogn. 2012 Jun;21(2):751-63. doi: 10.1016/j.concog.2012.02.006. Epub 2012 Mar 11.

    PMID: 22414738BACKGROUND
  • Andrews SC, Hoy KE, Enticott PG, Daskalakis ZJ, Fitzgerald PB. Improving working memory: the effect of combining cognitive activity and anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex. Brain Stimul. 2011 Apr;4(2):84-9. doi: 10.1016/j.brs.2010.06.004. Epub 2010 Jul 11.

    PMID: 21511208BACKGROUND
  • Brooks SJ, O'Daly OG, Uher R, Friederich HC, Giampietro V, Brammer M, Williams SC, Schioth HB, Treasure J, Campbell IC. Differential neural responses to food images in women with bulimia versus anorexia nervosa. PLoS One. 2011;6(7):e22259. doi: 10.1371/journal.pone.0022259. Epub 2011 Jul 20.

    PMID: 21799807BACKGROUND
  • Brooks SJ, O'Daly O, Uher R, Friederich HC, Giampietro V, Brammer M, Williams SC, Schioth HB, Treasure J, Campbell IC. Thinking about eating food activates visual cortex with reduced bilateral cerebellar activation in females with anorexia nervosa: an fMRI study. PLoS One. 2012;7(3):e34000. doi: 10.1371/journal.pone.0034000. Epub 2012 Mar 27.

    PMID: 22479499BACKGROUND
  • Brooks SJ, Barker GJ, O'Daly OG, Brammer M, Williams SC, Benedict C, Schioth HB, Treasure J, Campbell IC. Restraint of appetite and reduced regional brain volumes in anorexia nervosa: a voxel-based morphometric study. BMC Psychiatry. 2011 Nov 17;11:179. doi: 10.1186/1471-244X-11-179.

    PMID: 22093442BACKGROUND
  • Van den Eynde F, Claudino AM, Mogg A, Horrell L, Stahl D, Ribeiro W, Uher R, Campbell I, Schmidt U. Repetitive transcranial magnetic stimulation reduces cue-induced food craving in bulimic disorders. Biol Psychiatry. 2010 Apr 15;67(8):793-5. doi: 10.1016/j.biopsych.2009.11.023. Epub 2010 Jan 8.

    PMID: 20060105BACKGROUND
  • Brooks SJ, Benedict C, Burgos J, Kempton MJ, Kullberg J, Nordenskjold R, Kilander L, Nylander R, Larsson EM, Johansson L, Ahlstrom H, Lind L, Schioth HB. Late-life obesity is associated with smaller global and regional gray matter volumes: a voxel-based morphometric study. Int J Obes (Lond). 2013 Feb;37(2):230-6. doi: 10.1038/ijo.2012.13. Epub 2012 Jan 31.

    PMID: 22290540BACKGROUND
  • Olivo G, Wiemerslage L, Swenne I, Zhukovsky C, Salonen-Ros H, Larsson EM, Gaudio S, Brooks SJ, Schioth HB. Correction: Limbic-thalamo-cortical projections and reward-related circuitry integrity affects eating behavior: A longitudinal DTI study in adolescents with restrictive eating disorders. PLoS One. 2017 Apr 20;12(4):e0176646. doi: 10.1371/journal.pone.0176646. eCollection 2017.

    PMID: 28426755BACKGROUND
  • Olivo G, Wiemerslage L, Swenne I, Zhukowsky C, Salonen-Ros H, Larsson EM, Gaudio S, Brooks SJ, Schioth HB. Limbic-thalamo-cortical projections and reward-related circuitry integrity affects eating behavior: A longitudinal DTI study in adolescents with restrictive eating disorders. PLoS One. 2017 Mar 1;12(3):e0172129. doi: 10.1371/journal.pone.0172129. eCollection 2017.

    PMID: 28248991BACKGROUND
  • Olivo G, Zhou W, Sundbom M, Zhukovsky C, Hogenkamp P, Nikontovic L, Stark J, Wiemerslage L, Larsson EM, Benedict C, Schioth HB. Resting-state brain connectivity changes in obese women after Roux-en-Y gastric bypass surgery: A longitudinal study. Sci Rep. 2017 Jul 26;7(1):6616. doi: 10.1038/s41598-017-06663-5.

    PMID: 28747648BACKGROUND
  • Gaudio S, Carducci F, Piervincenzi C, Olivo G, Schioth HB. Altered thalamo-cortical and occipital-parietal- temporal-frontal white matter connections in patients with anorexia and bulimia nervosa: a systematic review of diffusion tensor imaging studies. J Psychiatry Neurosci. 2019 Sep 1;44(5):324-339. doi: 10.1503/jpn.180121.

    PMID: 30994310BACKGROUND
  • Olivo G, Swenne I, Zhukovsky C, Tuunainen AK, Saaid A, Salonen-Ros H, Larsson EM, Brooks SJ, Schioth HB. Preserved white matter microstructure in adolescent patients with atypical anorexia nervosa. Int J Eat Disord. 2019 Feb;52(2):166-174. doi: 10.1002/eat.23012. Epub 2019 Jan 24.

    PMID: 30676658BACKGROUND
  • Olivo G, Swenne I, Zhukovsky C, Tuunainen AK, Salonen-Ros H, Larsson EM, Gaudio S, Brooks SJ, Schioth HB. Reduced resting-state connectivity in areas involved in processing of face-related social cues in female adolescents with atypical anorexia nervosa. Transl Psychiatry. 2018 Dec 13;8(1):275. doi: 10.1038/s41398-018-0333-1.

    PMID: 30546060BACKGROUND
  • Gaudio S, Olivo G, Beomonte Zobel B, Schioth HB. Altered cerebellar-insular-parietal-cingular subnetwork in adolescents in the earliest stages of anorexia nervosa: a network-based statistic analysis. Transl Psychiatry. 2018 Jul 6;8(1):127. doi: 10.1038/s41398-018-0173-z.

    PMID: 29980676BACKGROUND
  • Olivo G, Solstrand Dahlberg L, Wiemerslage L, Swenne I, Zhukovsky C, Salonen-Ros H, Larsson EM, Gaudio S, Brooks SJ, Schioth HB. Atypical anorexia nervosa is not related to brain structural changes in newly diagnosed adolescent patients. Int J Eat Disord. 2018 Jan;51(1):39-45. doi: 10.1002/eat.22805. Epub 2017 Dec 7.

    PMID: 29215777BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia Nervosa

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Christina Zhukovsky, MMed

    Uppsala University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2013

First Posted

June 20, 2013

Study Start

May 1, 2011

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2031

Last Updated

May 6, 2026

Record last verified: 2026-04

Locations