Clinical trial NCT02980120: Personality Pathology and Cerebral Processing in Eating Disorders
Official title: Personality Pathology and Cerebral Processing in Eating Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eating Disorders
Keywords: Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 110
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include 50 female patients with AN, 30 female patients with BN and 30 healthy females

Brief summary: The proposed study will investigate whether, on the basis of personality traits and personality disorders as well as specific cerebral activation patterns shows differences in adolescent female with anorexia nervosa (AN), bulimia nervosa (BN) and a healthy control group.

Detailed description: The increasing prevalence of eating disorders in adolescence and their frequent chronic course have led to the development of various programs for prevention, early detection and early intervention. Nevertheless, the causes of anorexia nervosa (AN) and bulimia nervosa (BN) remain a topic of much discussion and research. Evidence points to a multifactorial disease pattern in which intrapsychic, psychosocial and biological factors interact and reinforce one another. Eating disorders have been increasingly associated with signs of emotional and psychological disturbance. In clinical populations, personality traits are observed as exacerbating factors that constitute important variables for differentiation. While investigations have shown high comorbidity of personality disorders and eating disorders in adulthood, comparable studies in adolescence have not yet been undertaken.

The proposed study will investigate whether, on the basis of personality traits and personality disorders as well as specific cerebral activation patterns, differentiations can be identified among adolescent female patients with AN (n = 50) and BN (n = 30) in comparison to a healthy control group (n = 30).

Of particular interest is the potential connection between specific personality traits and neural correlates in the two ED:

1. Do specific personality traits and personality disorders correlate significantly with particular types of ED?
2. Do AN and BN correlate significantly with particular cerebral activation patterns following visual presentation of food stimuli and gustatory stimuli? 3. Can connections be identified between specific personality profiles and cerebral activation patterns in AN and BN? 4. Will changes in cerebral activation patterns be evident between the beginning of treatment (T1) and the end of treatment (T2)? The study will use specific questionnaires dealing with eating behavior (EDI \& EAT) as well as clinical interviews for the assessment of personality disorders (SCID II). Cerebral processing will be evaluated using functional MRI (fMRI) and structural MRI. fMRI results from visual and gustatory stimuli will be correlated with structural brain morphology in MRI and with psychopathological parameters. The correlation of such clinical values represents a new approach to the investigation of eating disorders in adults and may be of significant relevance for data interpretation and understanding of cerebral changes due to anorexia. MRI measurements will be performed at begin of therapy (T1) and at end of therapy (T2).

In this fashion, known risk factors will be supplemented with information on specific personality traits and cerebral activation patterns. The proposed study will thus provide important new insights for early detection, prevention, treatment and clinical assessment.

Eligibility criteria: Inclusion Criteria:

• The study will include 50 female patients with AN, 30 female patients with BN and 30 healthy females

Exclusion Criteria:

* Age \>18 years or \<14 years
* Extremely underweight patients requiring pediatric treatment for medical stability and improvement of cognitive functioning prior to psychiatric inpatient treatment Overweight and obese patients with BMI z-scores extrapolated from the adult BMI cut-off \> 25.0
* Acute or chronic somatic or functional diseases (i.e. strokes, tumors, heart conditions)
* A history of head trauma or fainting
* Left-handedness (determined by a standardized questionnaire)
* Evidence of structural brain abnormality on the structural MRI scan (conducted on the first day of the study)
* fMRI-specific exclusion criteria (phobic anxiety, claustrophobia, ADHD etc.)
* Pregnancy (assessed with urine pregnancy test)
* Allergy to chocolate
* Schizophrenia and other psychotic disorders
* Shrapnel or other electronic/metal implants in the body (i.e. pacemakers, surgical devices etc.)

Primary outcomes:
measure: Neural correlates (fMRI): Differences on cerebral activation patterns in the AN and BN groups from those in the control group
timeFrame: At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)
Secondary outcomes:
measure: Personality pathology: Identification of specific personality profiles (dimensional personality traits and personality disorders) using a structured clinical interview and questionnaire
timeFrame: (T1) Week 1
measure: Relationship between personality pathology (using structured clinical interview and questionnaire) and neural correlates in ED (fMRI)
timeFrame: At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department for Child and Adolescent Psychiatry
state: Tirol
Study officials:
affiliation: Head of department of Child and Adolescent Psychiatry
name: Kathrin Seveke, Univ-Prof.Dr
role: PRINCIPAL_INVESTIGATOR
References: