drugset / Trial / NCT04714541

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

NCT04714541

Phase 1 Completed 5 enrolled Homeostasis Therapeutics, LLC
NaSingle-groupOpen-labelTreatment

Summary

This Open-Label Pilot Study Aims to Determine Whether a Two-Part Sequenced Out Patient Procedure Utilizing a Modified Ketogenic Diet Followed by a Series of Titrated Ketamine Infusions Results in Improvement or Remission of Chronic Anorexia Nervosa in Adults with Symptoms of Anorexia for at Least 3 Years Despite Treatment Involving at Least 2 Different Modalities. The Hypothesis is That the Diet Addresses Core Metabolic Deficits in the "Anorexic Brain" and Primes the Response to Ketamine.

Timeline

Start
2021-04-12
Primary completion
2022-07-26
Completion
2022-07-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 0.75 mg/kg Intravenous

Indications