MedTrace Logo

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

NCT04714541 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-11-04

No results posted yet for this study

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.

Conditions

  • Anorexia Nervosa

Interventions

DRUG

Ketamine Hcl 50Mg/Ml Inj

Racemic Ketamine Will Be Infused At A Starting Dose of 0.75 mg/kg Over A Period of 45 Minutes. The Dose Will be Titrated, Based on Clinical Signs With Changes of 0.3mg/kg Up to Maximum of 0.95 mg/kg, and Lowest Dose of 0.3 mg/kg

Sponsors & Collaborators

  • Homeostasis Therapeutics, LLC

    lead INDUSTRY

Principal Investigators

  • Lori Calabrese, MD · Innovative Psychiatry So Windsor

  • Lori Calabrese, MD · Innovative Psychiatry, So Windsor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-12
Primary Completion
2022-07-26
Completion
2022-07-26
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04714541 on ClinicalTrials.gov