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COMPLETED Phase 1

Modified Ketogenic Diet and Ketamine for Anorexia Nervosa

NCT04714541 · View on ClinicalTrials.gov ↗

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 Studied

Interventions

  • DRUG Ketamine Hcl 50Mg/Ml Inj

Study Locations (1)

Connecticut

  • Lori Calabrese MD Innovative Psychiatry — South Windsor

Trial Details

FieldValue
Enrollment Target 5 participants
Start Date 2021-04-12
Est. Completion 2022-07-26
Phase Phase 1

Sponsor

Homeostasis Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04714541

The ClinicalTrials.gov registry entry for NCT04714541 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Homeostasis Therapeutics, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Anorexia Nervosa appearing as the primary indexed condition, and to 1 intervention — of which Ketamine Hcl 50Mg/Ml Inj is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04714541 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04714541 about?

NCT04714541 is a clinical study titled "Modified Ketogenic Diet and Ketamine for Anorexia Nervosa". 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 ...

What is the current status of trial NCT04714541?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2021-04-12. Estimated completion is 2022-07-26.

What conditions does trial NCT04714541 study?

This clinical trial studies the following conditions: Anorexia Nervosa. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04714541?

The interventions under investigation include: Ketamine Hcl 50Mg/Ml Inj (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04714541?

This trial is sponsored by Homeostasis Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04714541 being conducted?

This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial