Eating DisordersEAT_FMRINCT02980120
Personality Pathology and Cerebral Processing in Eating Disorders
An observational study of Eating Disorders, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders
- What is being tested?
- SCID-I, EAT and EDI-2
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 110 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2015to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 14 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: The study will include 50 female patients with AN, 30 female patients with BN and 30 healthy females
Who may be able to join
- The study will include 50 female patients with AN, 30 female patients with BN and 30 healthy females
Who cannot join
- 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)
Show all 11Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Department for Child and Adolescent Psychiatry
Innsbruck, Tyrol, 6020
About this study
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.
Read the 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:
- Do specific personality traits and personality disorders correlate significantly with particular types of ED?
- 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.
- Conditions
- Eating Disorders
- Being tested
- SCID-I, EAT, EDI-2, SCID-II, LoPF
- Keywords
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- Medical subject headings
- Feeding and Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCID-IOther
Also called Structured Clinical Interview for DSM-IV
The structured clinical interview for DSM-IV Axis I Disorder (SCID-I, German translation, see Wittchen, Zaudig \& Fydrich, 1997) is a semi-structured interview to diagnose AN and BM. It allows a detailed assessment of ED symptoms across different settings and time periods necessary to make an accurate diagnosis.
EATOther
Also called Eating Attitudes Test
The Eating Attitudes Test (EAT) is a standardized questionnaire of symptoms and concerns related to ED (Garner \& Garfield, 1979, German translation by Steinhausen). The questionnaire consists of 40 items on a six-point Likert scale, providing information
EDI-2Other
Also called Eating Disorder Inventory 2
The Eating Disorder Inventory 2 (Paul \& Thiel, 2004) is a self-report questionnaire on psychological features generally associated with AN and BN.The instrument consists of 91 items on a six-point Likert scale. The 11 scales are drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, maturity fears, asceticism (provisional), impulse regulation (provisional) and social insecurity (provisional). It was designed as a diagnostic aid; its psychometrics have been tested, with studies demonstrating satisfactory internal consistency reliability coefficients (between .44 and .93), test-retest reliability of .79 to .95 (after one week) and above .80 (after three weeks), and content, convergent and discriminant validity.
SCID-IIOther
Also called Structured Clinical Interview for DSM-IV
The SCID-II interview (German, see Wittchen, Zaudig \& Fydrich, 1997) is a widely used and researched instrument to assess DSM-IV-TR personality disorders.The interview covers all ten DSM-IV personality disorders (antisocial, avoidant, borderline, dependent, histrionic, narcissistic, obsessive-compulsive, paranoid, schizoid and schizotypal), PD not otherwise specified, and appendix categories (depressive PD and passive-aggressive PD) and is used to make personality disorder diagnoses either dimensionally or categorically (present-absent). Furthermore, it allows the investigation of patterns of PD that co-occur with other mental disorders as well as the analysis of the underlying structure of personality pathology.
LoPFOther
Also called Levels of personality functioning
In order to specifically focus on certain personality traits, we use the LoPF as an additional measure. It is a well-validated and reliable self-report questionnaire to measure healthy and pathological personality functioning in adolescents. It is based on the DSM-5 Section III Alternative Model for Personality disorders and covers core impairments in adolescents' personality functioning: identity, self-direction (self-related personality functioning), intimacy/ attachment and empathy/ social-related personality functioning (Sevecke \& Krischer, 2011).
HAWIK-IVOther
Also called Wechsler Intelligence Scale for Children
The Wechsler Intelligence Scale for Children (HAWIK-IV, Petermann \& Petermann, 2008) will be used assess intelligence. For adolescents older than 16.11 years, we will use the German version of the Wechsler Adult Intelligence Scale (HAWIE-IV).Results from test-retest reliability demonstrate that the mean retest scores for all subtests are higher than the mean test scores from first administration, with effect sizes ranging from .08 (comprehension) to .60 (picture completion). The test has demonstrated an acceptable relationship to other measures of achievement, memory, adaptive behavior, emotional intelligence and giftedness in children and adolescents (Canivez, 2014). For the non-clinical adolescent sample, we will use two subtests of the HAWIK.
fMRIDevice
Also called Food-related brain activation by event-related fMRI
To measure food-related brain activation, event-related fMRI will be used, with phases of high-caloric images alternating with phases of low-caloric images and images of fixation cross (not related to food images). A total of 18 blocks will be performed - see figure below. The duration of each phase will be 30 seconds. In a second run, the patients and control subjects will drink chocolate milk and water, alternating every 30 seconds, through a long silicon tube. This procedure was successfully tested in a previous fMRI study with adult AN patients (Gizewski et al. 2010, Vocks et al. 2011) and has now been adopted in preliminary measurements for young AN patients.
| Study group | Role | What they receive |
|---|---|---|
| Anorexia Nervosa Group | n=50 female patients with Anorexia Nervosa (AN) who fulfill the criteria for DSM-IV, BMI z-scores will be used for age and sex specific cut-off points that are extrapolated from the adult BMI cut-off <17.5 Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI Receives: Other: SCID-I; Other: EAT; Other: EDI-2; Other: SCID-II; Other: LoPF; Other: HAWIK-IV; Device: fMRI | |
| Bulimia Nervosa Group | n=30 female patients with Bulimia Nervosa (BN) who have BMI z-scores from the adult range <17.5-25.0 (this reflects the lower prevalence rates of BN compared to AN) Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI Receives: Other: SCID-I; Other: EAT; Other: EDI-2; Other: SCID-II; Other: LoPF; Other: HAWIK-IV; Device: fMRI | |
| Healthy Control Group | n=30 healthy females who have BMI z-scores from the adult range from 19.0-25.0 and who do not fulfill diagnostic criteria for any psychiatric disorder.Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI Receives: Other: SCID-I; Other: EAT; Other: EDI-2; Other: SCID-II; Other: LoPF; Other: HAWIK-IV; Device: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural correlates (fMRI): Differences on cerebral activation patterns in the AN and BN groups from those in the control group
Cerebral activation patterns ((activation of prefrontal, parahippocampal, cinculate, and insular cortex, posterior cingulate cortex ) in the AN and BN groups will differ from those in the control group
Measured: At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)
Secondary outcomes (2)
Personality pathology: Identification of specific personality profiles (dimensional personality traits and personality disorders) using a structured clinical interview and questionnaire
Specific personality profiles (dimensional traits and personality disorders) can be identified in adolescent patients with AN and BN; evaluated from SCID-II interview (scores ranging from 108-324) and LoPF questionnaire (T-scores)
Measured: (T1) Week 1
Relationship between personality pathology (using structured clinical interview and questionnaire) and neural correlates in ED (fMRI)
Personality pathology will correlate significantly with the cerebral activation patterns (fMRI brain activation, SCID-scores and T-scores)
Measured: At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study startJan 2015
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies 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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathrin Sevecke, Medical University Innsbruck
- Investigators
- Kathrin Seveke, Univ-Prof.Dr, Principal investigator, Head of department of Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980120
- Sponsor's protocol ID
- EAT_FMRI
- Acronym
- EAT_FMRI
- Status last verified
- Mar 2018
- First submitted
- 9 Nov 2016
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Dabkowska-Mika A, Steiger R, Gander M, Haid-Stecher N, Fuchs M, Sevecke K, Gizewski ER. Evaluation of visual food stimuli paradigms on healthy adolescents for future use in fMRI studies in anorexia nervosa. J Eat Disord. 2023 Mar 6;11(1):35. doi: 10.1186/s40337-023-00761-8.
PubMed 36879292
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personality Pathology and Cerebral Processing in Eating Disorders
- ClinicalTrials.gov ID
- NCT02980120
- Acronym / sponsor ID
- EAT_FMRI / EAT_FMRI
- Conditions
- Eating Disorders
- Keywords
- Eating Disorders, Anorexia Nervosa, Bulimia Nervosa
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 2 Dec 2016 (estimated)
- 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.
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:
- Do specific personality traits and personality disorders correlate significantly with particular types of ED?
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Anorexia Nervosa Group | – | Other: SCID-I, Other: EAT, Other: EDI-2, Other: SCID-II, Other: LoPF, Other: HAWIK-IV, Device: fMRIn=50 female patients with Anorexia Nervosa (AN) who fulfill the criteria for DSM-IV, BMI z-scores will be used for age and sex specific cut-off points that are extrapolated from the adult BMI cut-off <17.5 Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI |
| Bulimia Nervosa Group | – | Other: SCID-I, Other: EAT, Other: EDI-2, Other: SCID-II, Other: LoPF, Other: HAWIK-IV, Device: fMRIn=30 female patients with Bulimia Nervosa (BN) who have BMI z-scores from the adult range <17.5-25.0 (this reflects the lower prevalence rates of BN compared to AN) Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI |
| Healthy Control Group | – | Other: SCID-I, Other: EAT, Other: EDI-2, Other: SCID-II, Other: LoPF, Other: HAWIK-IV, Device: fMRIn=30 healthy females who have BMI z-scores from the adult range from 19.0-25.0 and who do not fulfill diagnostic criteria for any psychiatric disorder.Interventions:EDI-2, EAT, SCID-I, SCID-II, LoPF, HAWIK-IV, fMRI |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study will include 50 female patients with AN, 30 female patients with BN and 30 healthy females
Key inclusion criteria (1 listed)
- The study will include 50 female patients with AN, 30 female patients with BN and 30 healthy females
Key exclusion criteria (11 listed)
- 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)
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 |
|---|---|---|
| SCID-IAlso: Structured Clinical Interview for DSM-IVThe structured clinical interview for DSM-IV Axis I Disorder (SCID-I, German translation, see Wittchen, Zaudig \& Fydrich, 1997) is a semi-structured interview to diagnose AN and BM. It allows a detailed assessment of ED symptoms across different settings and time periods necessary to make an accurate diagnosis. | Other | Anorexia Nervosa Group, Bulimia Nervosa Group, Healthy Control Group |
| EATAlso: Eating Attitudes TestThe Eating Attitudes Test (EAT) is a standardized questionnaire of symptoms and concerns related to ED (Garner \& Garfield, 1979, German translation by Steinhausen). The questionnaire consists of 40 items on a six-point Likert scale, providing information | Other | Anorexia Nervosa Group, Bulimia Nervosa Group, Healthy Control Group |
| EDI-2Also: Eating Disorder Inventory 2The Eating Disorder Inventory 2 (Paul \& Thiel, 2004) is a self-report questionnaire on psychological features generally associated with AN and BN.The instrument consists of 91 items on a six-point Likert scale. The 11 scales are drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, maturity fears, asceticism (provisional), impulse regulation (provisional) and social insecurity (provisional). It was designed as a diagnostic aid; its psychometrics have been tested, with studies demonstrating satisfactory internal consistency reliability coefficients (between .44 and .93), test-retest reliability of .79 to .95 (after one week) and above .80 (after three weeks), and content, convergent and discriminant validity. | Other | Anorexia Nervosa Group, Bulimia Nervosa Group, Healthy Control Group |
| SCID-IIAlso: Structured Clinical Interview for DSM-IVThe SCID-II interview (German, see Wittchen, Zaudig \& Fydrich, 1997) is a widely used and researched instrument to assess DSM-IV-TR personality disorders.The interview covers all ten DSM-IV personality disorders (antisocial, avoidant, borderline, dependent, histrionic, narcissistic, obsessive-compulsive, paranoid, schizoid and schizotypal), PD not otherwise specified, and appendix categories (depressive PD and passive-aggressive PD) and is used to make personality disorder diagnoses either dimensionally or categorically (present-absent). Furthermore, it allows the investigation of patterns of PD that co-occur with other mental disorders as well as the analysis of the underlying structure of personality pathology. | Other | Anorexia Nervosa Group, Bulimia Nervosa Group, Healthy Control Group |
| LoPFAlso: Levels of personality functioningIn order to specifically focus on certain personality traits, we use the LoPF as an additional measure. It is a well-validated and reliable self-report questionnaire to measure healthy and pathological personality functioning in adolescents. It is based on the DSM-5 Section III Alternative Model for Personality disorders and covers core impairments in adolescents' personality functioning: identity, self-direction (self-related personality functioning), intimacy/ attachment and empathy/ social-related personality functioning (Sevecke \& Krischer, 2011). | Other | Anorexia Nervosa Group, Bulimia Nervosa Group, Healthy Control Group |
| HAWIK-IVAlso: Wechsler Intelligence Scale for ChildrenThe Wechsler Intelligence Scale for Children (HAWIK-IV, Petermann \& Petermann, 2008) will be used assess intelligence. For adolescents older than 16.11 years, we will use the German version of the Wechsler Adult Intelligence Scale (HAWIE-IV).Results from test-retest reliability demonstrate that the mean retest scores for all subtests are higher than the mean test scores from first administration, with effect sizes ranging from .08 (comprehension) to .60 (picture completion). The test has demonstrated an acceptable relationship to other measures of achievement, memory, adaptive behavior, emotional intelligence and giftedness in children and adolescents (Canivez, 2014). For the non-clinical adolescent sample, we will use two subtests of the HAWIK. | Other | Anorexia Nervosa Group, Bulimia Nervosa Group, Healthy Control Group |
| fMRIAlso: Food-related brain activation by event-related fMRITo measure food-related brain activation, event-related fMRI will be used, with phases of high-caloric images alternating with phases of low-caloric images and images of fixation cross (not related to food images). A total of 18 blocks will be performed - see figure below. The duration of each phase will be 30 seconds. In a second run, the patients and control subjects will drink chocolate milk and water, alternating every 30 seconds, through a long silicon tube. This procedure was successfully tested in a previous fMRI study with adult AN patients (Gizewski et al. 2010, Vocks et al. 2011) and has now been adopted in preliminary measurements for young AN patients. | Device | Anorexia Nervosa Group, Bulimia Nervosa Group, Healthy Control Group |
Primary outcome
Neural correlates (fMRI): Differences on cerebral activation patterns in the AN and BN groups from those in the control group
Time frame: At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)
Cerebral activation patterns ((activation of prefrontal, parahippocampal, cinculate, and insular cortex, posterior cingulate cortex ) in the AN and BN groups will differ from those in the control group
2 secondary outcomes
Personality pathology: Identification of specific personality profiles (dimensional personality traits and personality disorders) using a structured clinical interview and questionnaire
Time frame: (T1) Week 1
Relationship between personality pathology (using structured clinical interview and questionnaire) and neural correlates in ED (fMRI)
Time frame: At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
- Derived from this study: PubMed 36879292Dabkowska-Mika A, Steiger R, Gander M, Haid-Stecher N, Fuchs M, Sevecke K, Gizewski ER. Evaluation of visual food stimuli paradigms on healthy adolescents for future use in fMRI studies in anorexia nervosa. J Eat Disord. 2023 Mar 6;11(1):35. doi: 10.1186/s40337-023-00761-8.
- 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. This study is not recruiting at the moment.
Kathrin Seveke, Univ-Prof.Dr principal investigator
Head of department of Child and Adolescent Psychiatry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eating Disorders, run by Medical University Innsbruck at 1 site in Austria.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauela Gander, Dr. (++4351250483248, manuela.gander@uibk.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neural correlates (fMRI): Differences on cerebral activation patterns in the AN and BN groups from those in the control group (time frame: At the begin of therapy (T1, week 1) and at the end of therapy (T2) (approx. 2 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02980120, which also lists 1 linked publication.
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 30 Mar 2018.