Re-nutrition in Severe Anorexia Nervosa

NCT02502617 | Completed

• 1 other identifier: RESAN
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Anorexia Nervosa

Keywords

Psychopathology; Cognition; Depression; Nutrition; Cortisol; Anorexia nervosa

Outcome Measures

Primary Outcomes (1)

• 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.

  4-6 months

Secondary Outcomes (2)

• Eating disorder psychopathology composite outcome measure.

  4-6 months

• Cortisol excretion (nmol Cortisol pr day).

  4-6 months

Study Arms (2)

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.

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.

Interventions

medical nutrition DIETARY_SUPPLEMENT

The participants are expected to improve their body weight with 10-30% during a closely monitored inpatient-treatment comprising nutritional rehabilitation.

Weight Improvement

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with severe AN referred to a specialized unit.

You may qualify if:

• \- Fulfilling Diagnostic and Statistical Manual (DSM)-5 criteria for AN.

You may not qualify if:

• 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.

Sponsors & Collaborators

• René Klinkby Støving: lead

Study Sites (2)

Center for Eating Disorders, Department of Endocrinology, Odense University Hospital

Odense, 5000, Denmark

Location

René Klinkby Støving

Odense, 5000, Denmark

Location

Related Publications (20)

• Treasure J, Claudino AM, Zucker N. Eating disorders. Lancet. 2010 Feb 13;375(9714):583-93. doi: 10.1016/S0140-6736(09)61748-7.

  PMID: 19931176 BACKGROUND

• Pollice 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.

  PMID: 9138049 BACKGROUND

• Andries 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.

  PMID: 24890912 BACKGROUND

• Stoving 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.

  PMID: 22410588 BACKGROUND

• Stoving 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.

  PMID: 20826003 BACKGROUND

• Stoving 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.

  PMID: 11393567 BACKGROUND

• Martins 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.

  PMID: 21776204 BACKGROUND

• Clausen 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.

  PMID: 19504471 BACKGROUND

• Clausen 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.

  PMID: 21472023 BACKGROUND

• Bagby 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.

  PMID: 8126688 BACKGROUND

• BECK 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.

  PMID: 13688369 BACKGROUND

• Beck AT, Steer, R.A., & Brown, G.K. Manual for the Beck Depression Inventory-II. San Antonio, TX: Psychological Corporation; 1996.

  BACKGROUND

• 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.

  PMID: 25504530 BACKGROUND

• Snaith 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.

  PMID: 3147074 BACKGROUND

• Bjelland 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.

  PMID: 11832252 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Garner DM, Olmsted MP, Polivy J, Garfinkel PE. Comparison between weight-preoccupied women and anorexia nervosa. Psychosom Med. 1984 May-Jun;46(3):255-66. doi: 10.1097/00006842-198405000-00007.

  PMID: 6739685 BACKGROUND

• Hemmingsen SD, Lichtenstein MB, Sjogren M, Gudex C, Larsen PV, Stoving RK. Cognitive performance in hospitalized patients with severe or extreme anorexia nervosa. Eat Weight Disord. 2023 Oct 21;28(1):86. doi: 10.1007/s40519-023-01585-w.

  PMID: 37864583 DERIVED

• Hemmingsen SD, Jensen NA, Larsen PV, Sjogren JM, Lichtenstein MB, Stoving RK. Cortisol, Depression, and Anxiety Levels Before and After Short-Term Intensive Nutritional Stabilization in Patients With Severe Anorexia Nervosa. Front Psychiatry. 2022 Jul 12;13:939225. doi: 10.3389/fpsyt.2022.939225. eCollection 2022.

  PMID: 35903636 DERIVED

• Hemmingsen SD, Lichtenstein MB, Hussain AA, Sjogren JM, Stoving RK. Case report: cognitive performance in an extreme case of anorexia nervosa with a body mass index of 7.7. BMC Psychiatry. 2020 Jun 5;20(1):284. doi: 10.1186/s12888-020-02701-1.

  PMID: 32503476 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine.

MeSH Terms

Conditions

Anorexia Nervosa; Depression

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• René K Støving, MD PhD

  Center for Eating Disorders, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 12, 2015
• First Posted: July 20, 2015
• Study Start: March 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: October 1, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)