Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anorexia Nervosa
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: The 5 Participants Undergo A Sequenced Treatment of Adopting A Ketogenic Diet For at Least 4 Weeks, Followed by A Series of Intravenous Ketamine InfusionsMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 65 years
- Gender
- Both males and females
Description
Participants Who Are Deemed Eligible Will Participate in an Open-Label Clinical Trial Using a Sequenced Treatment Previously Reported in One Case Study to Result in Complete and Sustained Remission of Anorexia Nervosa for Over One Year (and Continuing). Part 1 Involves a Group 2-Day Immersive In-Per...
Participants Who Are Deemed Eligible Will Participate in an Open-Label Clinical Trial Using a Sequenced Treatment Previously Reported in One Case Study to Result in Complete and Sustained Remission of Anorexia Nervosa for Over One Year (and Continuing). Part 1 Involves a Group 2-Day Immersive In-Person Educational Program to Begin a Modified Ketogenic Diet, Under the Supervision of a Nutritionist Who Has Decades of Experience in Designing Ketogenic Diets for Seizure Patients. This Group Experience is Followed by a 4 Week Period of At-Home Adoption of the Diet, With Close Phone and E-Mail Follow-up. Part 2 Involves Administration of a Series of Titrated Intravenous Ketamine Infusions Scheduled Over 2 Weeks. During Part 1, and Part 2, There Will Be a Range of Objective and Psychological Measures To Assess Safety and Response. The Participants Will be Followed For 12 Months.
Tracking Information
- NCT #
- NCT04714541
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Lori Calabrese, MD Innovative Psychiatry So Windsor Principal Investigator: Lori Calabrese, MD Innovative Psychiatry, So Windsor