NCT05357053

Brief Summary

The aim of the research project is to investigate the neurological, physiological and behavioral underpinnings associated with the development of anorexia nervosa in adolescents. The goal of the project is to enable new ways to both predict the course of the disease and to influence this process.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
21mo left

Started Jan 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress72%
Jan 2022Dec 2027

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 2, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

September 22, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

March 28, 2022

Last Update Submit

September 16, 2025

Conditions

Keywords

Anorexia nervosaMetabolismFunctional ImagingEating disorders

Outcome Measures

Primary Outcomes (1)

  • Changes in brain reward system and metabolism in anorexia nervosa patients

    Anorexia nervosa patients and controls are studied using fMRI imaging and followed up for 3 years. Reward system function is measured using fMRI and metabolism using blood oxygen level-dependent (BOLD) echo-planar imaging.

    3 years

Study Arms (2)

Anorexia nervosa patients

Anorexia nervosa patients

Healthy normal weight controls

Healthy normal weight controls

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The study population comprises 50 female adolescents with anorexia nervosa meeting the inclusion criteria. They are compared with 50 age and sex-matched healthy normal weight controls.

You may qualify if:

  • Female sex
  • Age 13-17 years
  • Body mass index \< 17.5 kg/m2
  • Currently fulfilling modified Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnosis criteria for anorexia nervosa with or without amenorrhea
  • Anorexia nervosa diagnosed within 2 yers
  • Female sex
  • Age 13-17 years
  • Body mass index 18,5-25 kg/m2
  • No lifetime history of obesity (Body mass index ≥ 30) or eating disorders

You may not qualify if:

  • Any chronic illness or medication that could affect glucose metabolism or neurotransmission
  • Any other current mental disorder (excluding anorexia nervosa for the patient participants)
  • Severe previous mental disorder (excluding anorexia nervosa for the patient participants)
  • Smoking of tobacco, snuffing, or use of narcotics
  • Abusive use of alcohol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turku PET Centre

Turku, 20521, Finland

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and fecal samples

MeSH Terms

Conditions

Anorexia NervosaFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Mental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Max Karukivi, MD, PhD

    Turku University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2022

First Posted

May 2, 2022

Study Start

January 1, 2022

Primary Completion

December 31, 2024

Study Completion (Estimated)

December 31, 2027

Last Updated

September 22, 2025

Record last verified: 2025-04

Locations