Anorexia Nervosa and Brain in Adolescence

Anorexia Nervosa Clinical Trial

Official title:

Anorexia Nervosa and Brain in Adolescence

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06380257
• Other study ID #: ANBA
• Status: Not yet recruiting
• Start date: September 2024
• Est. completion date: December 2030

Study information

• Verified date: April 2024
• Source: Kuopio University Hospital
• Contact: Virve Kekkonen, M.D.
• Phone: +35817173311
• Email: virve.kekkonen[@]pshyvinvointialue.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2030
• Est. primary completion date: August 2030
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 19 Years

Eligibility

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:

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.

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa

Intervention

Other:
• Observational study methods
Neuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kuopio University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychiatric evaluation	Self-rated questionnaires measuring somatic and mentalh health (such as EDE-Q, BDI, substance use measurements) and structured psychiatric diagnostic interview (SCID)	Baseline and at 3 years' follow-up
Other	Body composition measurement	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)	Baseline and at 3 years' follow-up
Other	Laboratory tests	Blood sample (markers describing undernourishment, more precise description before study)	Baseline and at 3 years' follow-up
Primary	Neuroimaging	Transcranial magnetic stimulation (TMS) combined with electroencephalogram (EEG)	Baseline and at 3 years' follow-up
Secondary	Neuroimaging	Magnetic resonance imaging (MRI)	Baseline and at 3 years' follow-up