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NMDA Receptor Antagonist

Ketamine Hcl 50Mg/Ml Inj for Eating Disorders

Phase 1

Waitlist Available

Led By Lori Calabrese, MD

Research Sponsored by Homeostasis Therapeutics, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline biweekly for weeks 1,2,3, and 4, weekly for weeks 5,6,7,8.then 3 months, 6 months, 9 months, 12 months s and prior to every ketamine infusion 8 weeks; 3 months; 6 months; 9 months;12 months

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

Summary

This trial tests a two-step treatment for adults with long-term anorexia who haven't improved with other treatments. First, patients follow a special high-fat, low-carb diet to prepare their brains. Then, they receive specific amounts of ketamine through a drip. The goal is to see if this combination can improve or cure their anorexia.

Eligible Conditions

Eating Disorders
Anorexia Nervosa

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline biweekly for weeks 1,2,3, and 4, weekly for weeks 5,6,7,8.then 3 months, 6 months, 9 months, 12 months s and prior to every ketamine infusion 8 weeks; 3 months; 6 months; 9 months;12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline biweekly for weeks 1,2,3, and 4, weekly for weeks 5,6,7,8.then 3 months, 6 months, 9 months, 12 months s and prior to every ketamine infusion 8 weeks; 3 months; 6 months; 9 months;12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline biweekly for weeks 1,2,3, and 4, weekly for weeks 5,6,7,8.then 3 months, 6 months, 9 months, 12 months s and prior to every ketamine infusion 8 weeks; 3 months; 6 months; 9 months;12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Behavior and Mood and Thinking as Measured by Interview

Eating Disorders

Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score

+1 more

Secondary study objectives

Change in Body Weight/Body Mass Index

Other study objectives

Breath Acetone Measure

Brief 24- Hour Food Recall

Change in Depressive Symptoms as Assessed by Patient Health Questionnaire

+1 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Ketogenic Diet Adoption Followed by Ketamine InfusionExperimental Treatment1 Intervention

All 5 Participants Will Be Educated to Adopt a Ketogenic Diet, As Outpatient. After at Least 4 Weeks on the Diet, They Will Have A Series of Titrated Intravenous Ketamine Infusions Over A 2 Week Period

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketamine

FDA approved

Do I qualify?Apply below to find out