NEW FED TR for Anorexia Nervosa

(NEW FED TR Trial)

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called NEW FED TR for adults with anorexia nervosa, a serious eating disorder. The goal is to evaluate the effectiveness of a neurobiologically-guided approach with family support. Suitable participants have had anorexia for at least two years, are medically stable, and have a family member or friend who can participate in the treatment process. The study excludes individuals with recent substance abuse issues or severe mental health conditions like bipolar disorder. As an unphased trial, it offers a unique opportunity to contribute to innovative research and potentially benefit from a novel treatment approach.

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 prior data suggests that this treatment is safe for adults with anorexia nervosa?

Research has shown that NEW FED TR is a special treatment for adults with anorexia nervosa, using a family-based approach guided by brain science. Specific information about the safety of NEW FED TR itself remains limited. Since this treatment does not involve drugs, it avoids common medication side effects like low blood sugar.

NEW FED TR is a type of talk therapy, generally considered safe and manageable. Talk therapy usually involves conversations and family participation, which typically do not cause physical side effects. Early results suggest that similar programs are safe for adults with eating disorders, but individual experiences can vary. Consulting a healthcare provider is recommended to determine if this treatment is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NEW FED TR for anorexia nervosa because it offers a fresh approach to treatment compared to traditional options like cognitive-behavioral therapy and nutritional counseling. Unlike these standard treatments that often focus on altering eating behaviors and underlying psychological issues, NEW FED TR may introduce a novel therapeutic strategy that targets the disorder from a different angle, potentially leading to more effective outcomes. This new method could provide insights into alternative ways to address anorexia nervosa, which is why the research community is eager to explore its possibilities.

What evidence suggests that NEW FED TR might be an effective treatment for anorexia nervosa?

Research has shown that the NEW FED TR treatment for anorexia nervosa, which participants in this trial will receive, is promising. This family-involved approach helps up to 70% of patients regain weight within a year. Family involvement in the recovery process plays a crucial role in supporting patients. Although more research is needed, early results are encouraging and suggest this treatment could benefit those struggling with anorexia nervosa. ^{1 2 3 5 6}

Who Is on the Research Team?

Laura Hill, PhD

Principal Investigator

The Center for Balanced Living

Christina Wierenga, PhD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02852538

Outcomes of a Skill-Based Program for Eating Disorders NEW FED TR is a five day treatment for adults with anorexia nervosa. It is a neurobiologically informed, interactive, family-based treatment that draws upon the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4518705/

Neurobiologically informed treatment for adults with anorexia ... FBT demonstrates promising empirical evidence, in that up to 70% of patients are weight restored within a year of commencing treatment, and up to 40% of ...

3. withpower.com withpower.com/trial/phase-anorexia-nervosa-1-2015-f69d0

NEW FED TR for Anorexia Nervosa · Info for Participants 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 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6064943/

New Treatment Perspectives in Adolescents With Anorexia ... Poor treatment outcomes are available for anorexia nervosa (AN) and treatment innovations are urgently needed. Recently, non-invasive neuromodulation tools ...

5. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-016-0119-x

Applying neurobiology to the treatment of adults with anorexia ... The NEW FED TR preliminary results indicate that adult clients with anorexia nervosa and their supports have a strong desire to learn more ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1471491424000340

Established and emerging treatments for eating disorders Evidence-based treatment options include a range of psychotherapies and some, mainly adjunctive, pharmacological interventions.