Eating Disorders Trial, Recruiting NCT06000774 Sponsor: University of California, San Diego Condition: Eating Disorders
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Eating Disorders Trial, Recruiting

NCT06000774
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

Weight-Recovered Anorexia Nervosa Group:

  • You are willing to sign a consent form and follow all study procedures for the full duration of the study
  • You are between 18 and 45 years old
  • You have a history of anorexia nervosa as diagnosed by standard medical guidelines (DSM-5)
  • Your weight has recovered and your Body Mass Index (BMI) is above 17.5 at the time you join the study
  • You score at least 2 standard deviations above average on standard eating disorder questionnaires measuring eating disorder-related thoughts and behaviours (confirm with trial site)
  • You may still take certain psychiatric medications, including antidepressants, anti-anxiety medications, certain antipsychotics, or mood stabilisers
  • English is your primary spoken language

Underweight Anorexia Nervosa Sub-Study Group:

  • You are willing to sign a consent form and follow all study procedures for the full duration of the study
  • You are between 18 and 45 years old
  • You currently have anorexia nervosa as diagnosed by standard medical guidelines (DSM-5)
  • Your BMI is between 16.0 and 17.49 at the time you join the study
  • You score 2.09 or higher on a standard eating disorder questionnaire (EDE-Q) at the time of joining
  • You may still take certain psychiatric medications, including antidepressants, anti-anxiety medications, certain antipsychotics, or mood stabilisers
  • English is your primary spoken language

Bulimia Nervosa Pilot Group:

  • You are willing to sign a consent form and follow all study procedures for the full duration of the study
  • You are between 18 and 45 years old
  • You have a history of bulimia nervosa as diagnosed by standard medical guidelines (DSM-5)
  • You score 2.09 or higher on a standard eating disorder questionnaire (EDE-Q) at the time of joining
  • You may still take certain psychiatric medications, including antidepressants, anti-anxiety medications, certain antipsychotics, or mood stabilisers
  • English is your primary spoken language

Who may not be able to join:

(The following exclusions apply to all three groups)

  • You are currently pregnant or breastfeeding
  • You have abnormal results for electrolytes, blood counts, kidney function, or liver function (confirm with trial site)
  • You have a condition involving a break from reality, such as psychosis
  • You have a brain or memory-related condition, such as dementia, or a symptomatic traumatic brain injury
  • You currently have an alcohol use disorder or drug/substance use disorder as diagnosed by standard medical guidelines (DSM-5)
  • You have high blood pressure that is not currently under control
  • You have moderate or severe liver disease (confirm with trial site)
  • You have diabetes
  • You have a family history of a condition called porphyria
  • You have had a recent heart attack, have a vascular (blood vessel) disease, or have any other serious active medical condition, as assessed by the lead doctor on the study
  • You are unwilling or unable to follow a specific diet called the TKD (targeted ketogenic diet) for the whole length of the study
  • You are blind or unable to read

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Guido Frank, MD, University of California, San Diego

Phone: 848-246-5272

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
3 October 2023
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

To assess the safety and tolerability in individuals with anorexia nervosa who are weight recovered, individuals with anorexia nervosa who are currently underweight, and individuals with bulimia nervosa using weekly body weight measurements.; To assess the safety and tolerability in individuals with anorexia nervosa (AN) who are weight recovered, AN individuals who are currently underweight, and Bulimia Nervosa individuals using the Committee of Clinical Investigations UKU-Side Effect Scale; Measurement of drive for weight loss, fear of weight gain and body image distortion using the Eating Di...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov