Eating Disorders Clinical Trial
— ONPEDOfficial title:
A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating Disorders
Verified date | June 2024 |
Source | Milton S. Hershey Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this study is to evaluate the effectiveness of oral naltrexone tablets in pediatric and adolescent eating disorders, in particular anorexia nervosa and bulimia nervosa, as compared to placebo. Study participants will be patients in a partial hospitalization program or intensive outpatient program for eating disorder.
Status | Terminated |
Enrollment | 10 |
Est. completion date | May 21, 2024 |
Est. primary completion date | May 21, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 13 Years to 25 Years |
Eligibility | Inclusion Criteria: - Ages 13-25 (inclusive) - Any sex - Diagnoses of anorexia nervosa binge-purge subtype, bulimia nervosa, purging disorder, or atypical anorexia nervosa with bingeing or purging behaviors according to the Diagnostic and Statistical Manual version 5 diagnostic criteria - Electing to participate in child or adult partial hospitalization program for eating disorder treatment at MSHMC The diagnostic criteria for anorexia nervosa, binge-purge subtype, are: A. Restriction of energy intake relative to requirements, leading to a significantly low body weight in the context of age, sex, developmental trajectory, and physical health. Significantly low weight is defined as a weight that is less than minimally normal or, for children and adolescents, less than minimally expected. B. Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight. C. Disturbance in the way in which one's body weight or shape is experienced, undue influence of body weight or shape on self-evaluation, or persistent lack of recognition of the seriousness of the current low body weight D. During the last three months the individual has engaged in recurrent episodes of binge eating or purging behaviour (i.e. self-induced vomiting, or the misuse of laxatives, diuretics, or enemas).19 E. A diagnosis of atypical anorexia nervosa can be made when the body weight is normal or high If these patients engage in bingeing or purging behaviors as defined in anorexia nervosa, binge-purge subtype, they are eligible for inclusion in this study The diagnostic criteria for bulimia nervosa are: A. Recurrent episodes of binge eating. An episode of binge eating is characterized by B. both: i. Eating in a discrete period of time (e.g. within any 2 hour period), an amount of food that is definitely larger than what most individuals would eat in a similar period of time under similar circumstances; ii. A sense of lack of control over eating during the episodes (e.g. a feeling that one cannot stop eating or control what or how much one is eating. C. Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise. D. The binge eating and inappropriate compensatory behaviors both occur, on average, at least once a week for 3 months. E. Self-evaluation is unduly influenced by body shape and weight. F. The disturbance does not occur exclusively during episodes of anorexia nervosa. • The diagnostic criteria for purging disorder are: recurrent purging behavior to influence weight or shape (e.g. self-induced vomiting; misuse of laxatives, diuretics, or other medications) in the absence of binge eating. Exclusion Criteria: - Diagnosis of intellectual disability - History of known genetic or neurologic disease - Need for treatment with opioid painkillers - Weight <25kg - Inability to swallow pills - Lack of proficiency in written or spoken English - Urine drug screen positive for opioids at enrollment - Positive serum pregnancy test at enrollment - Lactation - Elevation of three times the upper limit of normal for age in either alanine aminotransferase (ALT) or asparagine aminotransferase (AST).High risk of suicide at enrollment on Columbia Suicide Severity Rating Scale (C-SSRS, for participants age 18-25) or Ask Suicide Screening Questions (ASQ, participants age 13 to 17) |
Country | Name | City | State |
---|---|---|---|
United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Rosemary Claire Roden | Children's Miracle Network |
United States,
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Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: The ED-15. Int J Eat Disord. 2015 Nov;48(7):1005-15. doi: 10.1002/eat.22430. Epub 2015 May 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | enrollment for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 1 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 2 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 3 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 4 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 5 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 6 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 7 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 8 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 9 for patients age 17 or older | |
Other | Columbia Suicide Severity Rating Scale (CSSRS) | Evidence-based metric evaluating for presence of suicidal ideation and severity | 6 months after enrollment for patients age 17 or older | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | enrollment for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 1 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 2 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 3 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 4 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 5 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 6 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 7 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 8 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | week 9 for patients age 16 or younger | |
Other | Ask Suicide Screening Questions (ASQ) | Evidence-based metric evaluating for presence of suicidal ideation and severity | 6 months after enrollment for patients age 16 or younger | |
Primary | ED-15 score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. | Time Frame: Measured at the following timepoints: enrollment | |
Primary | ED-15 score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. | Time Frame: Measured at the following timepoints: one week | |
Primary | ED-15 score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. | Time Frame: Measured at the following timepoints: three week | |
Primary | ED-15 score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. | Time Frame: Measured at the following timepoints: six weeks | |
Primary | ED-15 score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. | Time Frame: Measured at the following timepoints: nine weeks (last week of treatment) | |
Primary | ED-15 score | ED-15 is an evidenced-based metric of eating disorder symptom severity and frequency. | Time Frame: Measured at the following timepoints: 6 months after enrollment | |
Secondary | Eating Disorder Examination Questionnaire score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity | Measured at the following timepoints: enrollment | |
Secondary | Eating Disorder Examination Questionnaire score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity | Measured at the following timepoints: one week | |
Secondary | Eating Disorder Examination Questionnaire score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity | Measured at the following timepoints: three weeks | |
Secondary | Eating Disorder Examination Questionnaire score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity | Measured at the following timepoints: six weeks | |
Secondary | Eating Disorder Examination Questionnaire score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity | Measured at the following timepoints: nine weeks (last week of treatment) | |
Secondary | Eating Disorder Examination Questionnaire score (EDE-Q) | EDE-Q is an evidence-based metric of eating disorder severity | Measured at the following timepoints: 6 months after enrollment | |
Secondary | Patient Health Questionnaire score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Measured at the following timepoints: enrollment | |
Secondary | Patient Health Questionnaire score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Measured at the following timepoints: one week | |
Secondary | Patient Health Questionnaire score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Measured at the following timepoints: three weeks | |
Secondary | Patient Health Questionnaire score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Measured at the following timepoints: six weeks | |
Secondary | Patient Health Questionnaire score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Measured at the following timepoints: nine weeks (last week of treatment) | |
Secondary | Patient Health Questionnaire score (PHQ-9) | Evidence-based metric of depression, min = 0, max= 27, higher scores indicate more severe depression | Measured at the following timepoints: 6 months after enrollment | |
Secondary | Generalized Anxiety Disorder Screener score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Measured at the following timepoints: enrollment | |
Secondary | Generalized Anxiety Disorder Screener score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Measured at the following timepoints: one week | |
Secondary | Generalized Anxiety Disorder Screener score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Measured at the following timepoints: three weeks | |
Secondary | Generalized Anxiety Disorder Screener score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Measured at the following timepoints: six weeks | |
Secondary | Generalized Anxiety Disorder Screener score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Measured at the following timepoints: nine weeks (last week of treatment) | |
Secondary | Generalized Anxiety Disorder Screener score (GAD-7) | evidence-based metric of anxiety, min=0, max=21, higher scores indicate more severe anxiety | Measured at the following timepoints: 6 months after enrollment | |
Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm | Measured at the following timepoints: enrollment | |
Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm | Measured at the following timepoints: one week | |
Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm | Measured at the following timepoints: three weeks | |
Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm | Measured at the following timepoints: six weeks | |
Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm | Measured at the following timepoints: nine weeks (last week of treatment) | |
Secondary | Alexian Brothers Urge to Self-Injure Scale (ABUSI) | evidence-based metric of urge to self-harm | Measured at the following timepoints: 6 months after enrollment | |
Secondary | Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) | Evidence-based metric of impulsivity | Measured at the following timepoints: enrollment | |
Secondary | Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) | Evidence-based metric of impulsivity | Measured at the following timepoints: one week | |
Secondary | Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) | Evidence-based metric of impulsivity | Measured at the following timepoints: three weeks | |
Secondary | Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) | Evidence-based metric of impulsivity | Measured at the following timepoints: six weeks | |
Secondary | Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) | Evidence-based metric of impulsivity | Measured at the following timepoints: nine weeks (last week of treatment) | |
Secondary | Behavioral Inhibition System/Behavioral Activation System score (BIS/BAS) | Evidence-based metric of impulsivity | Measured at the following timepoints: 6 months after enrollment | |
Secondary | Rate of weight restoration | For participants who need to restore weight, will evaluate the rate of weight gain in care | Will evaluate total rate of weight restoration via chart review at the end of the study | |
Secondary | Rate of weight restoration | For participants who need to restore weight, will evaluate the rate of weight gain in care | Will evaluate total rate of weight restoration via chart review 6 months after enrollment | |
Secondary | Need For Higher Level of Care | Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility | Will evaluate total rate of weight restoration via chart review at the end of the study | |
Secondary | Need For Higher Level of Care | Need to leave the current level of care (where the study is being conducted) to go to a residential, inpatient, or hospital facility | Will evaluate total rate of weight restoration via chart review 6 months after enrollment |
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