Recruitment is now closed and the trial is underway.
Research Site: Innovative Psychiatry
Location: 1330 Sullivan Avenue, South Windsor, CT 06074
Principal Investigator: Lori Calabrese, MD
Purpose: To evaluate the effects of a novel sequenced procedure using a modified ketogenic diet followed by a short series of ketamine infusions in participants with chronic anorexia nervosa
IRB Committee: This study has been reviewed and approved by IntegReview IRB #01-2020ANKK.
Contact: Lori Calabrese, M.D. at (860) 648-8481 or drc@innovativepsychiatryct.com
Anorexia nervosa is a complex condition that can be debilitating and sometimes fatal. The rates of remission and recovery are low. Even with treatment, many adults have anorexic compulsions about food, weight, body image and exercise that persist for years. Many adults with anorexia are medically stable but stuck in their thought patterns and behaviors.
This study seeks to evaluate the effect of a novel two-phase approach to anorexia for medically stable adults who have had chronic anorexia for 3 years despite previous treatment. The study involves participating in a 2-day program in central Connecticut, adopting a modified ketogenic diet for a month, and then having a short series of ketamine infusions in our clinic. Participants will be followed by telephone and Zoom at regular intervals for 12 months to determine their response.
No compensation is provided.
Why Participate?
- You will learn about a novel metabolic approach to anorexia using a modified ketogenic diet from a registered dietitian with international expertise in designing ketogenic diets for neurologic conditions during a 2-day in-person program in central Connecticut
- You will learn about a two-phase sequenced approach to anorexia nervosa using this modified ketogenic diet, adopt it for a month with monitoring and support, and if qualified, you will be given a short series of IV ketamine infusions in our clinic
- You will have contact with the registered dietitian nutritionist, study staff, and the principal investigator
- Your symptoms of anorexia nervosa may improve
- You will be helping to advance medical research for a historically difficult-to-treat condition and under-served patient population
Your Rights
- Participation is entirely voluntary and withdrawal is permitted at any time
- All study data are kept entirely confidential
- Qualified health professionals will monitor your health as it relates to the study
Who Can Participate?
- Adults aged 18 to 65 years old who have been diagnosed with Anorexia Nervosa for at least 3 years, have tried at least 2 different treatments, and continue to have anorexic compulsions about food, body image and/or exercise
- Medically stable
WHAT NEXT?
- Click the link below to enter your contact details and answer some eligibility questions.
- We will then contact you by phone to discuss the trial and answer your questions.