Anorexia NervosaRESANNCT02502617
Re-nutrition in Severe Anorexia Nervosa
An observational study of Anorexia Nervosa, run by René Klinkby Støving at 2 sites in Denmark.
Trial summary
In anorexia nervosa (AN) it still remains to be clarified, which psychiatric symptoms are the direct consequence of malnutrition and adaptation to starvation and which are not. There is clinical consensus that depression/anxiety and cognitive impairments in AN mainly are sequelae to the malnutrition. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- medical nutrition
- How many people
- 36 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Mar 2016to Oct 2023
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe AN referred to a specialized unit.
Who may be able to join
- Fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AN.
Who cannot join
- Patients who can not fill Danish-language questionnaires.
- Patients who are primarily hospitalized a few days for water electrolyte correction only.
- Patients with active drug abuse.
- Patients with co-morbid schizophrenia.
- Patients where the psychopharmacological treatment qualitative is changed during the study period.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Center for Eating Disorders, Department of Endocrinology, Odense University Hospital
Odense, 5000
René Klinkby Støving
Odense, 5000
About this study
Official title: Effect of Intensive Re-nutrition on Eating Disorder Psychopathology, Cognitive Functions, Anxiety, Depression, and Cortisol Level in Severe Anorexia Nervosa
In anorexia nervosa (AN) it still remains to be clarified, which psychiatric symptoms are the direct consequence of malnutrition and adaptation to starvation and which are not. There is clinical consensus that depression/anxiety and cognitive impairments in AN mainly are sequelae to the malnutrition. However, this consensus is largely based on experimental starvation studies of healthy subjects back in 1940s and from famine- and food programs in the third world, whereas evidence from studies on AN is lacking.
The main objective of the study is in the detail to elucidate the short-term changes in the psychopathological profile, depression, anxiety, and cognitive functions in relations to intensive nutritional rehabilitation with weight gain of 10-30% in a specialized medical stabilization unit. Secondarily, it is examined whether cortisol levels are associated with depression/anxiety symptomatology and cognitive impairments. The hypothesis is that an improvement in nutritional status over a short time leads to clinically significant improvements in psychopathology and cognitive functions, which remain 2-3 months after discharge, making the patients more accessible to psychotherapy.
Read the detailed description
Anorexia nervosa (AN) is a syndrome characterized by a distorted body image and morbid fear of obesity. Restrictive eating and compensatory behavior in the form of excessive exercising or vomiting result in malnutrition. Repeated revisions of the diagnostic criteria in recent decades have by definition resulted in an increase in prevalence. The disease has the highest mortality among all psychiatric disorders. The majority of deaths is related to malnutrition and its consequences. There is no effective evidence-based treatment. At least 25% remain chronically undernourished and have a long course with prolonged hospitalizations in both psychiatric and medical units, social psychiatric institutions and - support, early retirement and premature death. The etiology remains unknown and it is unclear which of the psychological symptoms that are a consequence of malnutrition, and which ones are premorbid or comorbid.
Depression and anxiety are co-existing and familiar features of patients with AN and can occur in such a degree that it is termed comorbidity. Antidepressant therapy has not shown to have any therapeutic effect of AN. Varying degrees of cognitive impairment are also well known feature of the AN, but in the literature it is only scanty investigated and psychometric analyzed.
In the early stage of the disease, starvation and weight loss can be interpreted as a coping strategy that relieves anxiety and depressive symptoms. If this coping strategy works, then the effect may decreases in line with the severity of malnutrition. There is almost a clinical consensus that depression / anxiety and cognitive impairment in AN is sequelae to malnutrition. But, it is a consensus that rely mainly on experimental studies of healthy subjects back in the postwar years observations from famine and from food programs in the 3rd World. Knowledge of the relationship between psychopathology and malnutrition in AN is still limited to a few and small studies with contradictory conclusions. In a recent study of hospitalized patients, no correlations between body mass index (BMI) and selected psychometric variables could be detected, with the essential limitation that it was a cross-sectional study of a population of patients with a narrow BMI range. To our knowledge, only one longitudinal study on changes in BMI and depressive symptoms have been published. In that study, mean weight gain was a significant predictor of reduced score in several of the "specific" eating disorder symptoms, such as concerns about diet, while weight gain was not a predictor of concern about body nor for depressive symptoms. To our knowledge, no longitudinal re-nutrition studies of the relationship between weight gain and anxiety or cognitive functions has been published.
A consequence of starvation stress is that all the endocrine axes are altered in AN, leading to protein- and energy preserving adaptation. Thus, in particular, increased levels of cortisol is well described in both AN and in patients with primary affective disorders. Depression/anxiety and cognitive impairment is also a well-described side effect of pharmacological treatment with corticosteroids and is well-known symptoms in excess endogenous cortisol production (mb. Cushing). Moreover, neuroanatomical animal studies indicate that cortisol per se has neurotoxic properties and may play a pathogenic role in affective disorders and anxiety. There is preliminary experimental evidence that pharmacological cortisol synthesis inhibition may have therapeutic efficacy in depression. However, so far this is not investigated in AN. In one study, it was found that cortisol levels correlated positively with anxiety and depression.
Center for Eating Disorders at Odense University Hospital is one of three highly specialized national centers in Denmark. Within the center, there is a formalized collaboration between the psychiatric and somatic units. Patients with life-threatening weight loss are primarily hospitalized in the Nutrition section for somatic stabilization and weight gain typically, 10-40%, and then either transferred to the psychiatric department or discharged for two-track psychiatric / somatic outpatient treatment. The Nutrition section receives severely ill patients from the nation. The median BMI of 84 admissions in year 2013 was 13.8 (the range 7.8 - 25.8). Internationally, there are only few somatic units of similar specialization and patient volume, which constitute the basis for studying the effect of intensive re-nutrition per se. The center's organization and patient population is described in several observational and intervention studies.
International and national guidelines recommend that treatment of AN should be interdisciplinary and double-track psychiatric - somatic. But, it is not clear how far and how fast nutritional rehabilitation may have beneficial effects on depression, anxiety and cognitive impairment in patients with severe AN.
- Conditions
- Anorexia Nervosa
- Being tested
- medical nutrition
- Keywords
- Psychopathology, Cognition, Depression, Nutrition, Cortisol, Anorexia nervosa
- Medical subject headings
- Anorexia Nervosa, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
medical nutritionDietary supplement
The participants are expected to improve their body weight with 10-30% during a closely monitored inpatient-treatment comprising nutritional rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| Weight Improvement | Patients (n = 30) with severe AN, refered to the specialized medical nutrition section at Odense University Hospital are tested three times during nutritional rehabilitation: At admission, at discharge (or drop out) and two-four months after discharge. The first study is carried out not before the third day of hospitalization after acclimatization and water electrolyte correction. Receives: Dietary Supplement: medical nutrition | |
| Weight-stable | To investigate the re-test effects of the the surveys, outpatients with a stable weight (less than 5%/3 months) with eating disorders (n = 15) are tested twice with 4-6 weeks interval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression/anxiety and cognitive functions composite outcome measure.
Depression/anxiety and cognitive functions composite outcome measure. [Time Frame: 4-6 months] [Safety Issue: No] Admission, discharge, and 2-4 months after discharge. Composite outcome measure consisting of the following psychometry: Beck Depression Inventory version 2 (BDI-II), Hospital Anxiety and Depression Scale (HADS), The Perceived Stress Scale (PSS), Wechsler Memory Scale - Third Edition (WMS-III), Wechsler Adult Intelligent Scale-IV, D2 test, Delis-Kaplan Executive Function System (Trail Making Test, Design Fluency Test and Verbal Fluency Test) and Wisconsin Card Sorting Test - Revised. A total score for each of the psychometric subscales will be calculated and tested in pairs with appropriate corrections for multiple testing.
Measured: 4-6 months
Secondary outcomes (2)
Eating disorder psychopathology composite outcome measure.
Admission, discharge, and 2-4 months after discharge. Composite outcome measure consisting of the following psychometry: Eating Disorder Inventory-3 (EDI-3) and Toronto Alexithymia Scale (TAS-20). A total score for each of the subscales in EDI-3 and for TAS-20 will be calculated and tested in pairs.
Measured: 4-6 months
Cortisol excretion (nmol Cortisol pr day).
Chromatographic mass spectrometric analysis of mixed day urine at admission, discharge, and 2-4 months after discharge.
Measured: 4-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study start1 Mar 2016
- Primary completionDec 2022
- Study completionOct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Anorexia NervosaStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- René Klinkby Støving
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, René Klinkby Støving, Odense University Hospital
- Investigators
- René K Støving, MD PhD, Principal investigator, Center for Eating Disorders, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502617
- Sponsor's protocol ID
- RESAN
- Acronym
- RESAN
- Status last verified
- Feb 2024
- First submitted
- 12 Jul 2015
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Data will be entered in Odense Patient data Explorative Network (OPEN).
Publications
Treasure J, Claudino AM, Zucker N. Eating disorders. Lancet. 2010 Feb 13;375(9714):583-93. doi: 10.1016/S0140-6736(09)61748-7.
PubMed 19931176Pollice C, Kaye WH, Greeno CG, Weltzin TE. Relationship of depression, anxiety, and obsessionality to state of illness in anorexia nervosa. Int J Eat Disord. 1997 May;21(4):367-76. doi: 10.1002/(sici)1098-108x(1997)21:43.0.co;2-w.
PubMed 9138049Andries A, Gram B, Stoving RK. Effect of dronabinol therapy on physical activity in anorexia nervosa: a randomised, controlled trial. Eat Weight Disord. 2015 Mar;20(1):13-21. doi: 10.1007/s40519-014-0132-5. Epub 2014 Jun 3.
PubMed 24890912Stoving RK, Andries A, Brixen KT, Bilenberg N, Lichtenstein MB, Horder K. Purging behavior in anorexia nervosa and eating disorder not otherwise specified: a retrospective cohort study. Psychiatry Res. 2012 Jul 30;198(2):253-8. doi: 10.1016/j.psychres.2011.10.009. Epub 2012 Mar 10.
PubMed 22410588Stoving RK, Andries A, Brixen K, Bilenberg N, Horder K. Gender differences in outcome of eating disorders: a retrospective cohort study. Psychiatry Res. 2011 Apr 30;186(2-3):362-6. doi: 10.1016/j.psychres.2010.08.005. Epub 2010 Sep 9.
PubMed 20826003Stoving RK, Hangaard J, Hagen C. Update on endocrine disturbances in anorexia nervosa. J Pediatr Endocrinol Metab. 2001 May;14(5):459-80. doi: 10.1515/jpem.2001.14.5.459.
PubMed 11393567Martins VJ, Toledo Florencio TM, Grillo LP, do Carmo P Franco M, Martins PA, Clemente AP, Santos CD, de Fatima A Vieira M, Sawaya AL. Long-lasting effects of undernutrition. Int J Environ Res Public Health. 2011 Jun;8(6):1817-46. doi: 10.3390/ijerph8061817. Epub 2011 May 26.
PubMed 21776204Clausen L, Rokkedal K, Rosenvinge JH. Validating the eating disorder inventory (EDI-2) in two Danish samples: a comparison between female eating disorder patients and females from the general population. Eur Eat Disord Rev. 2009 Nov;17(6):462-7. doi: 10.1002/erv.945.
PubMed 19504471Clausen L, Rosenvinge JH, Friborg O, Rokkedal K. Validating the Eating Disorder Inventory-3 (EDI-3): A Comparison Between 561 Female Eating Disorders Patients and 878 Females from the General Population. J Psychopathol Behav Assess. 2011 Mar;33(1):101-110. doi: 10.1007/s10862-010-9207-4. Epub 2010 Oct 19.
PubMed 21472023Bagby RM, Taylor GJ, Parker JD. The Twenty-item Toronto Alexithymia Scale--II. Convergent, discriminant, and concurrent validity. J Psychosom Res. 1994 Jan;38(1):33-40. doi: 10.1016/0022-3999(94)90006-x.
PubMed 8126688BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
PubMed 13688369Beck AT, Steer, R.A., & Brown, G.K. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.
Fuss S, Trottier K, Carter J. An investigation of the factor structure of the beck depression inventory-II in anorexia nervosa. Eur Eat Disord Rev. 2015 Jan;23(1):43-50. doi: 10.1002/erv.2338. Epub 2014 Dec 14.
PubMed 25504530Snaith P, Zigmond AS. Anxiety and depression in general medical settings. BMJ. 1988 Dec 10;297(6662):1544. doi: 10.1136/bmj.297.6662.1544. No abstract available.
PubMed 3147074Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res. 2002 Feb;52(2):69-77. doi: 10.1016/s0022-3999(01)00296-3.
PubMed 11832252
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intensive Re-nutrition on Eating Disorder Psychopathology, Cognitive Functions, Anxiety, Depression, and Cortisol Level in Severe Anorexia Nervosa
- ClinicalTrials.gov ID
- NCT02502617
- Acronym / sponsor ID
- RESAN / RESAN
- Conditions
- Anorexia Nervosa
- Keywords
- Psychopathology, Cognition, Depression, Nutrition, Cortisol, Anorexia nervosa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- René Klinkby StøvingUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Oct 2023 (actual)
- First posted
- 20 Jul 2015 (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.
In anorexia nervosa (AN) it still remains to be clarified, which psychiatric symptoms are the direct consequence of malnutrition and adaptation to starvation and which are not. There is clinical consensus that depression/anxiety and cognitive impairments in AN mainly are sequelae to the malnutrition. However, this consensus is largely based on experimental starvation studies of healthy subjects back in 1940s and from famine- and food programs in the third world, whereas evidence from studies on AN is lacking.
The main objective of the study is in the detail to elucidate the short-term changes in the psychopathological profile, depression, anxiety, and cognitive functions in relations to intensive nutritional rehabilitation with weight gain of 10-30% in a specialized medical stabilization unit. Secondarily, it is examined whether cortisol levels are associated with depression/anxiety symptomatology and cognitive impairments. The hypothesis is that an improvement in nutritional status over a short time leads to clinically significant improvements in psychopathology and cognitive functions, which remain 2-3 months after discharge, making the patients more accessible to psychotherapy.
Detailed description
Anorexia nervosa (AN) is a syndrome characterized by a distorted body image and morbid fear of obesity. Restrictive eating and compensatory behavior in the form of excessive exercising or vomiting result in malnutrition. Repeated revisions of the diagnostic criteria in recent decades have by definition resulted in an increase in prevalence. The disease has the highest mortality among all psychiatric disorders. The majority of deaths is related to malnutrition and its consequences. There is no effective evidence-based treatment. At least 25% remain chronically undernourished and have a long course with prolonged hospitalizations in both psychiatric and medical units, social psychiatric institutions and - support, early retirement and premature death. The etiology remains unknown and it is unclear which of the psychological symptoms that are a consequence of malnutrition, and which ones are premorbid or comorbid.
Depression and anxiety are co-existing and familiar features of patients with AN and can occur in such a degree that it is termed comorbidity. Antidepressant therapy has not shown to have any therapeutic effect of AN. Varying degrees of cognitive impairment are also well known feature of the AN, but in the literature it is only scanty investigated and psychometric analyzed.
In the early stage of the disease, starvation and weight loss can be interpreted as a coping strategy that relieves anxiety and depressive symptoms. If this coping strategy works, then the effect may decreases in line with the severity of malnutrition. There is almost a clinical consensus that depression / anxiety and cognitive impairment in AN is sequelae to malnutrition. But, it is a consensus that rely mainly on experimental studies of healthy subjects back in the postwar years observations from famine and from food programs in the 3rd World. Knowledge of the relationship between psychopathology and malnutrition in AN is still limited to a few and small studies with contradictory conclusions. In a recent study of hospitalized patients, no correlations between body mass index (BMI) and selected psychometric variables could be detected, with the essential limitation that it was a cross-sectional study of a population of patients with a narrow BMI range. To our knowledge, only one longitudinal study on changes in BMI and depressive symptoms have been published. In that study, mean weight gain was a significant predictor of reduced score in several of the "specific" eating disorder symptoms, such as concerns about diet, while weight gain was not a predictor of concern about body nor for depressive symptoms. To our knowledge, no longitudinal re-nutrition studies of the relationship between weight gain and anxiety or cognitive functions has been published.
A consequence of starvation stress is that all the endocrine axes are altered in AN, leading to protein- and energy preserving adaptation. Thus, in particular, increased levels of cortisol is well described in both AN and in patients with primary affective disorders. Depression/anxiety and cognitive impairment is also a well-described side effect of pharmacological treatment with corticosteroids and is well-known symptoms in excess endogenous cortisol production (mb. Cushing). Moreover, neuroanatomical animal studies indicate that cortisol per se has neurotoxic properties and may play a pathogenic role in affective disorders and anxiety. There is preliminary experimental evidence that pharmacological cortisol synthesis inhibition may have therapeutic efficacy in depression. However, so far this is not investigated in AN. In one study, it was found that cortisol levels correlated positively with anxiety and depression.
Center for Eating Disorders at Odense University Hospital is one of three highly specialized national centers in Denmark. Within the center, there is a formalized collaboration between the psychiatric and somatic units. Patients with life-threatening weight loss are primarily hospitalized in the Nutrition section for somatic stabilization and weight gain typically, 10-40%, and then either transferred to the psychiatric department or discharged for two-track psychiatric / somatic outpatient treatment. The Nutrition section receives severely ill patients from the nation. The median BMI of 84 admissions in year 2013 was 13.8 (the range 7.8 - 25.8). Internationally, there are only few somatic units of similar specialization and patient volume, which constitute the basis for studying the effect of intensive re-nutrition per se. The center's organization and patient population is described in several observational and intervention studies.
International and national guidelines recommend that treatment of AN should be interdisciplinary and double-track psychiatric - somatic. But, it is not clear how far and how fast nutritional rehabilitation may have beneficial effects on depression, anxiety and cognitive impairment in patients with severe AN.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weight Improvement | – | Dietary Supplement: medical nutritionPatients (n = 30) with severe AN, refered to the specialized medical nutrition section at Odense University Hospital are tested three times during nutritional rehabilitation: At admission, at discharge (or drop out) and two-four months after discharge. The first study is carried out not before the third day of hospitalization after acclimatization and water electrolyte correction. |
| Weight-stable | – | –To investigate the re-test effects of the the surveys, outpatients with a stable weight (less than 5%/3 months) with eating disorders (n = 15) are tested twice with 4-6 weeks interval. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe AN referred to a specialized unit.
Key inclusion criteria (1 listed)
- Fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AN.
Key exclusion criteria (5 listed)
- Patients who can not fill Danish-language questionnaires.
- Patients who are primarily hospitalized a few days for water electrolyte correction only.
- Patients with active drug abuse.
- Patients with co-morbid schizophrenia.
- Patients where the psychopharmacological treatment qualitative is changed during the study period.
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 |
|---|---|---|
| medical nutritionThe participants are expected to improve their body weight with 10-30% during a closely monitored inpatient-treatment comprising nutritional rehabilitation. | Dietary supplement | Weight Improvement |
Primary outcome
Depression/anxiety and cognitive functions composite outcome measure.
Time frame: 4-6 months
Depression/anxiety and cognitive functions composite outcome measure. [Time Frame: 4-6 months] [Safety Issue: No] Admission, discharge, and 2-4 months after discharge. Composite outcome measure consisting of the following psychometry: Beck Depression Inventory version 2 (BDI-II), Hospital Anxiety and Depression Scale (HADS), The Perceived Stress Scale (PSS), Wechsler Memory Scale - Third Edition (WMS-III), Wechsler Adult Intelligent Scale-IV, D2 test, Delis-Kaplan Executive Function System (Trail Making Test, Design Fluency Test and Verbal Fluency Test) and Wisconsin Card Sorting Test - Revised. A total score for each of the psychometric subscales will be calculated and tested in pairs with appropriate corrections for multiple testing.
2 secondary outcomes
Eating disorder psychopathology composite outcome measure.
Time frame: 4-6 months
Cortisol excretion (nmol Cortisol pr day).
Time frame: 4-6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 19931176Treasure J, Claudino AM, Zucker N. Eating disorders. Lancet. 2010 Feb 13;375(9714):583-93. doi: 10.1016/S0140-6736(09)61748-7.
- Background: PubMed 9138049Pollice C, Kaye WH, Greeno CG, Weltzin TE. Relationship of depression, anxiety, and obsessionality to state of illness in anorexia nervosa. Int J Eat Disord. 1997 May;21(4):367-76. doi: 10.1002/(sici)1098-108x(1997)21:43.0.co;2-w.
- Background: PubMed 24890912Andries A, Gram B, Stoving RK. Effect of dronabinol therapy on physical activity in anorexia nervosa: a randomised, controlled trial. Eat Weight Disord. 2015 Mar;20(1):13-21. doi: 10.1007/s40519-014-0132-5. Epub 2014 Jun 3.
- Background: PubMed 22410588Stoving RK, Andries A, Brixen KT, Bilenberg N, Lichtenstein MB, Horder K. Purging behavior in anorexia nervosa and eating disorder not otherwise specified: a retrospective cohort study. Psychiatry Res. 2012 Jul 30;198(2):253-8. doi: 10.1016/j.psychres.2011.10.009. Epub 2012 Mar 10.
- Background: PubMed 20826003Stoving RK, Andries A, Brixen K, Bilenberg N, Horder K. Gender differences in outcome of eating disorders: a retrospective cohort study. Psychiatry Res. 2011 Apr 30;186(2-3):362-6. doi: 10.1016/j.psychres.2010.08.005. Epub 2010 Sep 9.
- Background: PubMed 11393567Stoving RK, Hangaard J, Hagen C. Update on endocrine disturbances in anorexia nervosa. J Pediatr Endocrinol Metab. 2001 May;14(5):459-80. doi: 10.1515/jpem.2001.14.5.459.
- Background: PubMed 21776204Martins VJ, Toledo Florencio TM, Grillo LP, do Carmo P Franco M, Martins PA, Clemente AP, Santos CD, de Fatima A Vieira M, Sawaya AL. Long-lasting effects of undernutrition. Int J Environ Res Public Health. 2011 Jun;8(6):1817-46. doi: 10.3390/ijerph8061817. Epub 2011 May 26.
- Background: PubMed 19504471Clausen L, Rokkedal K, Rosenvinge JH. Validating the eating disorder inventory (EDI-2) in two Danish samples: a comparison between female eating disorder patients and females from the general population. Eur Eat Disord Rev. 2009 Nov;17(6):462-7. doi: 10.1002/erv.945.
- Background: PubMed 21472023Clausen L, Rosenvinge JH, Friborg O, Rokkedal K. Validating the Eating Disorder Inventory-3 (EDI-3): A Comparison Between 561 Female Eating Disorders Patients and 878 Females from the General Population. J Psychopathol Behav Assess. 2011 Mar;33(1):101-110. doi: 10.1007/s10862-010-9207-4. Epub 2010 Oct 19.
- Background: PubMed 8126688Bagby RM, Taylor GJ, Parker JD. The Twenty-item Toronto Alexithymia Scale--II. Convergent, discriminant, and concurrent validity. J Psychosom Res. 1994 Jan;38(1):33-40. doi: 10.1016/0022-3999(94)90006-x.
- Background: PubMed 13688369BECK AT, WARD CH, MENDELSON M, MOCK J, ERBAUGH J. An inventory for measuring depression. Arch Gen Psychiatry. 1961 Jun;4:561-71. doi: 10.1001/archpsyc.1961.01710120031004. No abstract available.
- BackgroundBeck AT, Steer, R.A., & Brown, G.K. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.
- Individual participant dataSharing planned: No. Data will be entered in Odense Patient data Explorative Network (OPEN).
Related trials for Anorexia Nervosa
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
RecruitingObservational study
Speech Groups for Children Living With a Sibling Who Suffers From Anorexia Nervosa
Anorexia Nervosa
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Not yet recruitingObservational study
Biomarkers in EV Associated With Marrow Adiposity in Anorexia
Anorexia Nervosa Restricting Type, Anorexia Nervosa (DSM-IV Revised Criteria)
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
René K Støving, MD PhD principal investigator
Center for Eating Disorders, Odense University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anorexia Nervosa, run by René Klinkby Støving at 2 sites in Denmark.
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 5 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: finished, as of the sponsor's last update on 6 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression/anxiety and cognitive functions composite outcome measure. (time frame: 4-6 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 NCT02502617, which also lists 20 linked publications.
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 6 Feb 2024.