- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06380257
Anorexia Nervosa and Brain in Adolescence
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Virve Kekkonen, M.D.
- Phone Number: +35817173311
- Email: virve.kekkonen@pshyvinvointialue.fi
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Study group
Adolescents diagnosed with anorexia nervosa or atypical anorexia nervosa.
|
Neuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups.
|
|
Control Group
Healthy adolescents.
|
Neuroimaging, body compostion, laboratory tests and psychiatric interview in study and in control groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuroimaging
Time Frame: Baseline and at 3 years' follow-up
|
Transcranial magnetic stimulation (TMS) combined with electroencephalogram (EEG)
|
Baseline and at 3 years' follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neuroimaging
Time Frame: Baseline and at 3 years' follow-up
|
Magnetic resonance imaging (MRI)
|
Baseline and at 3 years' follow-up
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Baseline and at 3 years' follow-up
|
|
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)
|
Baseline and at 3 years' follow-up
|
|
Laboratory tests
Time Frame: Baseline and at 3 years' follow-up
|
Blood sample (markers describing undernourishment, more precise description before study)
|
Baseline and at 3 years' follow-up
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Virve Kekkonen, M.D., Kuopio University Hospital
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ANBA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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