Anorexia NervosaNCT06380257
Anorexia Nervosa and Brain in Adolescence
An observational study of Anorexia Nervosa, run by Kuopio University Hospital.
Trial summary
Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence. Read more about this study
- Who is it for?
- Ages 16 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Observational study methods
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Study group: 1) age 16-19 years, 2) BMI below 17.5, 3) diagnosis: anorexia nervosa or atypical anorexia nervosa 4) diagnosed within last two years. Inclusion criteria.
- Control group : 1) age 16-19 years, 2) BMI over 19.0, 3) No lifetime obesity (BMI over 30) nor eating disorder.
Who cannot join
- 1) 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence.
Read the detailed description
Anorexia nervosa is severe mental health problem with increased incidence rates in adolescence. Etiology of anorexia nervosa is still mostly unkonwn. Adolescence is also critical period of brain development.
Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in both acute and remission state of anorexia nervosa in adolescence.
Study group are young anorexia nervosa patients, and control group are healthy same-aged students.
Research methods include non-invasive brain imaging methods such as Transcranial Magnetic Stimulation (TMS), and Magnetic Resonance Imaging (MRI). Other research methods are assessment of body composition, laboratory tests, self-rated questionnaires and psychiatric interview.
- Conditions
- Anorexia Nervosa
- Being tested
- Observational study methods
- Medical subject headings
- Anorexia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study methodsOther
Neuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Adolescents diagnosed with anorexia nervosa or atypical anorexia nervosa. Receives: Other: Observational study methods | |
| Control Group | Healthy adolescents. Receives: Other: Observational study methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroimaging
Transcranial magnetic stimulation (TMS) combined with electroencephalogram (EEG)
Measured: Baseline and at 3 years' follow-up
Secondary outcomes (1)
Neuroimaging
Magnetic resonance imaging (MRI)
Measured: Baseline and at 3 years' follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionDec 2030 (estimated)
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.
- 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Virve Kekkonen, Kuopio University Hospital
- Investigators
- Virve Kekkonen, M.D., Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380257
- Sponsor's protocol ID
- ANBA
- Status last verified
- Apr 2024
- First submitted
- 5 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anorexia Nervosa and Brain in Adolescence
- ClinicalTrials.gov ID
- NCT06380257
- Acronym / sponsor ID
- ANBA
- Conditions
- Anorexia Nervosa
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 23 Apr 2024 (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.
Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in adolescence.
Detailed description
Anorexia nervosa is severe mental health problem with increased incidence rates in adolescence. Etiology of anorexia nervosa is still mostly unkonwn. Adolescence is also critical period of brain development.
Aims of this follow-up study are to investigate effects of anorexia nervosa on brain structure and functions in both acute and remission state of anorexia nervosa in adolescence.
Study group are young anorexia nervosa patients, and control group are healthy same-aged students.
Research methods include non-invasive brain imaging methods such as Transcranial Magnetic Stimulation (TMS), and Magnetic Resonance Imaging (MRI). Other research methods are assessment of body composition, laboratory tests, self-rated questionnaires and psychiatric interview.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: Observational study methodsAdolescents diagnosed with anorexia nervosa or atypical anorexia nervosa. |
| Control Group | – | Other: Observational study methodsHealthy adolescents. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Study group: 1) age 16-19 years, 2) BMI below 17.5, 3) diagnosis: anorexia nervosa or atypical anorexia nervosa 4) diagnosed within last two years. Inclusion criteria.
- Control group : 1) age 16-19 years, 2) BMI over 19.0, 3) No lifetime obesity (BMI over 30) nor eating disorder.
Key exclusion criteria (1 listed)
- 1) 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.
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 |
|---|---|---|
| Observational study methodsNeuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups. | Other | Control Group, Study group |
Primary outcome
Neuroimaging
Time frame: Baseline and at 3 years' follow-up
Transcranial magnetic stimulation (TMS) combined with electroencephalogram (EEG)
1 secondary outcome
Neuroimaging
Time frame: Baseline and at 3 years' follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Virve Kekkonen, M.D. principal investigator
Kuopio University Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by Kuopio University Hospital.
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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Virve Kekkonen, M.D. (+35817173311, virve.kekkonen@pshyvinvointialue.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuroimaging (time frame: Baseline and at 3 years' follow-up). 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 23 Apr 2024.