Case Series: A Sequenced Treatment Using a Modified Ketogenic Diet and Ketamine for Severe and Enduring Anorexia Nervosa
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Change in Behavior and Mood and Thinking as Measured by Interview
研究概览
简要总结
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.
详细描述
Participants Who Are Deemed Eligible Will Participate in an Open-Label Clinical Trial Using a Sequenced Treatment Previously Reported in One Case Study to Result in Complete and Sustained Remission of Anorexia Nervosa for Over One Year (and Continuing).
Part 1 Involves a Group 2-Day Immersive In-Person Educational Program to Begin a Modified Ketogenic Diet, Under the Supervision of a Nutritionist Who Has Decades of Experience in Designing Ketogenic Diets for Seizure Patients. This Group Experience is Followed by a 4 Week Period of At-Home Adoption of the Diet, With Close Phone and E-Mail Follow-up.
Part 2 Involves Administration of a Series of Titrated Intravenous Ketamine Infusions Scheduled Over 2 Weeks.
During Part 1, and Part 2, There Will Be a Range of Objective and Psychological Measures To Assess Safety and Response. The Participants Will be Followed For 12 Months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults Between 18 and 65
- •Anorexia Nervosa Diagnosis For at Least 3 Years
- •Treatment Resistance, as Evidenced by Having Failed at Least 2 Treatments
- •Body Mass Index (BMI) Greater than or Equal to 18.5
- •Stable Weight for the Last 3 Months (No Consistent Change Greater than 5 Pounds)
- •Abstinence From Substance Abuse for At Least 3 Months
- •No Cannabis Use for At Least 3 Months
- •Currently Under the Care of a Primary Care Provider (PCP)
- •Participant Must Agree to have PCP Contacted by Study Staff
- •Willingness to Participant in a 2-Day Program in Central Connecticut
- •Identified Support Partner Who Will Attend Program
- •Willingness to Have Weight Recorded and Reported by PCP or Support Partner
- •Willingness to Attend 4-6 Clinic Visits For Ketamine Infusion
- •Willingness to Be Contacted for Follow Up for 12 Months
- •Willingness to Abide By All COVID Safety Measures
- •Exclusion Criteria
- •Concomitant Disease (Gastroentestinal, Renal, Respiratory, Cardiac, Etc) or Any Clinically Significant Finding at Screening that Would Pose a Risk to the Participant
- •Primary Carnitine Deficiency, Beta Oxidation Defects, Pyruvate Carboxylase Deficiency, Porphyria, or Treatment with Carbonic Anhydrase Inhibitors
- •Bulimia Nervosa as The Primary Diagnosis
- •Weight Change of Greater Than 5 Pounds in Last 3 Months
- •Pregnancy
- •Sexually Active Females Not Using Birth Control
- •Interstitial Cystitis
- •Unmanaged/Unstable Hypertenison (Greater than 140 Systolic; 90 Diastolic
- •Cardiac Arrythmia
- •Uncontrolled Seizure Disorder or Seizure Withen 30 Days Prior to Screening
- •QTc Interval of 470 ms or Greater
- •Current or Past History of Psychotic Disorder
- •Active Suicidal Ideation
- •Enrolled in any Clinical Trial or Used Any Investigational Agent, Device, and/or Investigational Procedure Within 30 Days Before Screening, or Does so Concurrently With this Study
排除标准
- 未提供
研究组 & 干预措施
Ketogenic Diet Adoption Followed by Ketamine Infusion
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
干预措施: Ketamine Hcl 50Mg/Ml Inj (Drug)
结局指标
主要结局
Change in Behavior and Mood and Thinking as Measured by Interview
时间窗: Change from Baseline at 4 Weeks, 8 Weeks, 3 Months, 6 Months, 9 Months, 12 Months
Qualitative Analysis of Research- Associate Administered Questionnaire
Changes in Eating Disorder Examination Questionnaire (EDE-Q) Score
时间窗: Change from Baseline at 4 weeks; 8 Weeks; 3 Months; 6 Months; 9 Months; 12 Months
A 28-item Self Report Scale that Assesses the Range and Severity of ED symptoms
Change in Eating Disorder Recovery Endorsement Questionnaire (EDREQ) Score
时间窗: Change from Baseline at 4 Weeks, 8 Weeks, 3 Months; 6 Months, 9 Months, 12 Months
Self Report Scale that Assesses The Indicators of Recovery
Change in Clinical Impairment Assessment (CIA) For Eating Disorders Scale
时间窗: Change from Baseline at 4 Weeks; 8 Weeks; 3 Months; 6 Months; 9 Months;12 Months
A 16-Item Self Administered Rating Scale Which Measures PsychoSocial Impairment
次要结局
- Change in Body Weight/Body Mass Index(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)