NCT06380257

Brief Summary

Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
56mo left

Started Sep 2024

Longer than P75 for all trials

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress27%
Sep 2024Dec 2030

First Submitted

Initial submission to the registry

April 5, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 23, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2030

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

April 23, 2024

Status Verified

April 1, 2024

Enrollment Period

5.9 years

First QC Date

April 5, 2024

Last Update Submit

April 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Neuroimaging

    Transcranial magnetic stimulation (TMS) combined with electroencephalogram (EEG)

    Baseline and at 3 years' follow-up

Secondary Outcomes (1)

  • Neuroimaging

    Baseline and at 3 years' follow-up

Other Outcomes (3)

  • Psychiatric evaluation

    Baseline and at 3 years' follow-up

  • Body composition measurement

    Baseline and at 3 years' follow-up

  • Laboratory tests

    Baseline and at 3 years' follow-up

Study Arms (2)

Study group

Adolescents diagnosed with anorexia nervosa or atypical anorexia nervosa.

Other: Observational study methods

Control Group

Healthy adolescents.

Other: Observational study methods

Interventions

Neuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups.

Control GroupStudy group

Eligibility Criteria

Age16 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Target study population is 50 participants. Study group (25 participants) are recruited from North Savo wellbeing services, Adolescent psychiatry outpatient clinic. Control group (25 participants) are recruited from Kuopio restrict lower and upper secondary schools.

You may qualify if:

  • Control group : 1) age 16-19 years, 2) BMI over 19.0, 3) No lifetime obesity (BMI over 30) nor eating disorder.

You may not qualify if:

  • \) glucose metabolism disorder or any chronic medical disorder, or medicine with possible effects on neurotransmitters, 2) previous mental health problem (excluded anorexia nervosa or atypical anorexia nervosa in study group), 3) smoking, nicotine products, alcohol or any other substance abuse or dependence, 4) contraindication for used brain imaging method.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Study Officials

  • Virve Kekkonen, M.D.

    Kuopio University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist in adolescent psychiatry, clinical lecturer

Study Record Dates

First Submitted

April 5, 2024

First Posted

April 23, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

April 23, 2024

Record last verified: 2024-04