NEW FED TR for Anorexia Nervosa

(NEW FED TR Trial)

Recruiting at 1 trial location

Overseen By Amber Scott

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Substance abuse, Suicidal thoughts, Psychotic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new treatment for adults with anorexia nervosa that uses brain science to guide intensive therapy sessions involving the patient's family.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment NEW FED TR for Anorexia Nervosa?

The research on early naso-gastric feeding (NGF) for anorexia nervosa shows that it can lead to longer times before relapse and may help patients recover faster, suggesting that nutritional rehabilitation is important. While this is not directly about NEW FED TR, it highlights the importance of early and effective nutritional support in treating anorexia nervosa. ^{1 2 3 4 5}

Is NEW FED TR safe for humans?

The safety data for treatments similar to NEW FED TR, like glucagon-like peptide-1 receptor agonists, show that they can cause low blood sugar (hypoglycemia) in some people. Additionally, there have been concerns about thyroid and pancreatic cancer with similar medications, but these are based on insurance claims data and need further investigation. ^{6 7 8 9 10}

How does the NEW FED TR treatment for anorexia nervosa differ from other treatments?

NEW FED TR is unique because it is a neurobiologically informed treatment that targets specific temperament traits associated with anorexia nervosa through psychoeducation and skills training for both patients and their caregivers, unlike traditional treatments that do not focus on these neurobiological mechanisms. ^{1 11 12 13 14}

Research Team

Laura Hill, PhD

Principal Investigator

The Center for Balanced Living

Christina Wierenga, PhD

Principal Investigator

University of California, San Diego

Eligibility Criteria

This trial is for adults who have been diagnosed with anorexia or anorexia nervosa at least two years ago and are medically stable. They must also have a carer willing to join them in treatment. People with current suicidal thoughts, recent substance abuse, developmental disorders, or severe psychiatric conditions like psychosis or bipolar disorder cannot participate.

Inclusion Criteria

My illness started at least 2 years ago.

My health condition is currently stable.

Identified carer to participate in treatment with participant

Exclusion Criteria

You have a condition that affects your ability to learn or develop normally.

You have a serious mental illness like schizophrenia or bipolar disorder.

I am experiencing thoughts of harming myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a neurobiologically-guided intensive family based treatment for anorexia nervosa

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• NEW FED TR

Trial Overview The study is testing NEW FED TR, which is a neurobiologically-informed intensive family-based treatment program designed specifically for adults suffering from anorexia nervosa.

Participant Groups

Group I: NEW FED TR for Anorexia Experimental Treatment 1 Intervention

NEW FED TR

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Eating Disorders Association

Collaborator

Trials

6

Recruited

530+

Findings from Research

In a study comparing the Mandometer treatment (MT) to treatment as usual (TAU) for anorexia nervosa, 63% of the MT group and 85% of the TAU group achieved normal weight after treatment, indicating that TAU was more effective for immediate weight recovery.

Both treatments showed similar outcomes on the Morgan Russell Outcome Assessment Schedule (MROAS), but after two years, more patients in the MT group remained in treatment and experienced relapses, suggesting that MT may not be as effective in the long-term management of anorexia nervosa compared to TAU.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mandometer treatment not superior to treatment as usual for anorexia nervosa. van Elburg, AA., Hillebrand, JJ., Huyser, C., et al.[2012]

In a study of 102 inpatients with anorexia nervosa, early treatment response, defined as gaining at least 0.5-1 kg per week in the first 6 weeks, significantly predicted a positive treatment outcome, making patients 18 times more likely to achieve a BMI of 17.5 kg/m².

Additionally, a higher admission body mass index (BMI) was associated with better treatment outcomes, indicating that both early weight gain and initial BMI are crucial factors in the recovery process for individuals with anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Positive Treatment Outcome in People With Anorexia Nervosa Treated in a Specialized Inpatient Unit: The Role of Early Response to Treatment. Wales, J., Brewin, N., Cashmore, R., et al.[2022]

A study analyzing 1,164 cases of hypoglycemia linked to glucagon-like peptide-1 receptor agonists (GLP-1RAs) found that lixisenatide had the strongest association with hypoglycemia, indicating a need for caution when prescribing this medication.

The median onset time for hypoglycemia after starting GLP-1RA treatment was 5 days, with a notable hospitalization rate of 56.08% and a fatality rate of 3.53%, highlighting the potential risks associated with these drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypoglycemia following the use of glucagon-like peptide-1 receptor agonists: a real-world analysis of post-marketing surveillance data. Zhao, Z., Tang, Y., Hu, Y., et al.[2022]

The term 'drug ineffective' (DI) was the most commonly reported adverse event in the FDA's FAERS database, accounting for 6.4% of all reports from September 2012 to August 2016, with most reports coming from consumers and primarily from the USA.

Despite the high frequency of DI reports, only 7.8% of evaluated reports were considered 'useful' for pharmacovigilance, indicating a need for better strategies to identify valuable information within these reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Evaluation of "Drug Ineffective" Postmarketing Reports in Drug Safety Surveillance. Misu, T., Kortepeter, CM., Muñoz, MA., et al.[2020]

In a study involving approximately 32,800 users of exenatide, there was a modestly higher incidence of claims for thyroid malignancies compared to users of metformin or glyburide, but this association was not significant when focusing on inpatient claims.

Exenatide use was not linked to an increased risk of benign thyroid neoplasms or pancreatic cancer, suggesting it may be a safe option regarding these specific cancer risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. Dore, DD., Seeger, JD., Chan, KA.[2021]

The Global Trigger Tool (GTT) demonstrated moderate accuracy in identifying adverse events (AEs) in adult inpatients, with a sensitivity of 0.41 and specificity of 0.68 for all AEs, but showed significantly higher sensitivity (0.85) and specificity (0.88) for more serious AEs classified as harm F-I.

The GTT missed several AEs related to nursing care, indicating that it should be used alongside other measurement strategies to provide a comprehensive assessment of patient safety and improve healthcare quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The accuracy of the Global Trigger Tool is higher for the identification of adverse events of greater harm: a diagnostic test study. Moraes, SM., Ferrari, TCA., Beleigoli, A.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Early Naso-Gastric Feeding and Outcomes of Anorexia Nervosa Patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Mandometer treatment not superior to treatment as usual for anorexia nervosa. [2012]

3. England pubmed.ncbi.nlm.nih.gov

Predictors of Positive Treatment Outcome in People With Anorexia Nervosa Treated in a Specialized Inpatient Unit: The Role of Early Response to Treatment. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of treatments for anorexia nervosa in adolescents: randomised controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Outcomes for adults with anorexia nervosa who do not respond early to outpatient treatment. [2021]

6. China pubmed.ncbi.nlm.nih.gov

Hypoglycemia following the use of glucagon-like peptide-1 receptor agonists: a real-world analysis of post-marketing surveillance data. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

An Evaluation of "Drug Ineffective" Postmarketing Reports in Drug Safety Surveillance. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Incidence of health insurance claims for thyroid neoplasm and pancreatic malignancy in association with exenatide: signal refinement using active safety surveillance. [2021]

9. England pubmed.ncbi.nlm.nih.gov

The accuracy of the Global Trigger Tool is higher for the identification of adverse events of greater harm: a diagnostic test study. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Assessing adverse drug reaction reports for antidiabetic medications approved by the food and drug administration between 2012 and 2017: a pharmacovigilance study. [2023]

11. England pubmed.ncbi.nlm.nih.gov

Neurobiologically informed treatment for adults with anorexia nervosa: a novel approach to a chronic disorder. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Long-term effects of enteral feeding on growth and mental health in adolescents with anorexia nervosa--results of a retrospective German cohort study. [2021]

13. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Trials Required to Assess Potential Benefits and Side Effects of Treatment of Patients With Anorexia Nervosa With Recombinant Human Leptin. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Enteral Nutrition via Nasogastric Tube for Refeeding Patients With Anorexia Nervosa: A Systematic Review. [2019]