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NCT Number: NCT06380257

Anorexia Nervosa and Brain in Adolescence

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

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Key information

Age range

16 year–19 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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.

Treatment and study plan

Observational study methods

Other

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

Primary outcomes

  1. Neuroimaging

    Time frame: Baseline and at 3 years' follow-up

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

Secondary outcomes

  1. Neuroimaging

    Time frame: Baseline and at 3 years' follow-up

    Magnetic resonance imaging (MRI)

Other outcomes

  1. Psychiatric evaluation

    Time frame: Baseline and at 3 years' follow-up

    Self-rated questionnaires measuring somatic and mentalh health (such as EDE-Q, BDI, substance use measurements) and structured psychiatric diagnostic interview (SCID)

  2. Body composition measurement

    Time frame: Baseline and at 3 years' follow-up

    InBody body composition measurement (non-invasive method to measure information about the quantity and segmentation of muscle, bone and fat tissue in body and about your basal metabolic rate)

  3. Laboratory tests

    Time frame: Baseline and at 3 years' follow-up

    Blood sample (markers describing undernourishment, more precise description before study)

Study contacts

Contact information is provided by the study sponsor or research team.

Virve Kekkonen, M.D.

CONTACT

[email protected]

+35817173311

Sponsors and collaborators

Lead sponsor

Kuopio University Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2030
Study completion
2030
First posted
Apr 23, 2024
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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