Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04714541 · ClinicalTrials.gov registry record · Phase 1
Modified Ketogenic Diet and Ketamine for Anorexia Nervosa
A Phase 1 study of Anorexia Nervosa, sponsored by Homeostasis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT04714541: Completed Phase 1 study of Anorexia Nervosa, sponsored by Homeostasis Therapeutics.
NCT04714541 is a Phase 1 study of Anorexia Nervosa that has completed, run by Homeostasis Therapeutics. The registered enrollment target is 5 participants, below the 950-participant average among 43 other Anorexia Nervosa trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04714541, a Phase 1 study of Anorexia Nervosa, has completed, sponsored by Homeostasis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
A 28-item Self Report Scale that Assesses the Range and Severity of ED symptoms
Conditions Studied
Interventions
- DRUG Ketamine Hcl 50Mg/Ml Inj
Study Locations (1)
Connecticut
- Lori Calabrese MD Innovative Psychiatry - South Windsor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-04-12 |
| Est. Completion | 2022-07-26 |
| Phase | Phase 1 |
What the finished NCT04714541 record still lists
NCT04714541 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 950-participant average among 43 other Anorexia Nervosa trials with a reported enrollment target (99% lower).
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.
NCT04714541 reports a single indexed study location in Connecticut.
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.
What interventions are being tested in trial NCT04714541?
The interventions under investigation include: Ketamine Hcl 50Mg/Ml Inj (DRUG).
Who is sponsoring clinical trial NCT04714541?
This trial is sponsored by Homeostasis Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Anorexia Nervosa
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04714541's enrollment target sits among peer trials
5 44th of 43 the lowest of 43 other Anorexia Nervosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anorexia Nervosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
tDCS and Cognitive Training for Restrictive Eating Disorders
RECRUITING · Phase 1
-
Metabolic Diet for Relapse Prevention in Anorexia Nervosa
RECRUITING · NA
-
Facing Eating Disorder Fears for Anorexia Nervosa
RECRUITING · NA
-
Therapeutic Ketogenic Diet in Anorexia Nervosa
RECRUITING · NA
-
Confirming the Effectiveness of Online Guided Self-Help Family-Based Treatment for Adolescent Anorexia Nervosa
RECRUITING · NA
-
Eating Disorders Genetics Initiative 2
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI