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Leállítva2/3. fázis

Oral Naltrexone In Pediatric Eating Disorders

A legfontosabb adatok

Ki végzi
Rosemary Claire Roden
Hol
Hershey (Egyesült Államok)A helyszín megnézése
Azonosító
Állapot
Leállítva
Fázis
2/3. fázis
Résztvevők
9 fő vett részt
Kezdés
2022. ápr. 22.
Befejezés
2024. máj. 21.
A vizsgálat típusa
Beavatkozással járó, 2 csoportAz egyik csoport placebót (hatóanyag nélküli szert) kap, összehasonlításként.
A vizsgált kezelések
  • Naltrexone Hydrochloride
  • Control
A regiszteradat frissítve
2025. augusztus 19.
Miért állt le
Low enrollment numbers, pharmacy not able to acquire sufficient study article component (methylcellulose) due to manufacturer backorder

Ki vehet részt

Életkor
13 év – 25 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 24 feltétel megnézéseKevesebb

Ki vehet részt

  • 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:
  • 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
  • Intense fear of gaining weight or of becoming fat, or persistent behavior that interferes with weight gain, even though at a significantly low weight
  • 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:
  • Recurrent episodes of binge eating. An episode of binge eating is characterized by
  • both:
  • 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
  • Recurrent inappropriate compensatory behaviors to prevent weight gain, such as self-induced vomiting; misuse of laxatives, diuretics, or other medications; fasting; or excessive exercise
  • The binge eating and inappropriate compensatory behaviors both occur, on average, at least once a week for 3 months
  • 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

Ki nem vehet részt

  • Need for treatment with opioid painkillers
  • Urine drug screen positive for opioids at enrollment
  • History of known genetic or neurologic disease
  • Positive serum pregnancy test at enrollment
  • 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)
  • Diagnosis of intellectual disability
  • Weight <25kg
  • Inability to swallow pills
  • Lack of proficiency in written or spoken English
  • Lactation

Helyszínek itt: Egyesült Államok

  • Penn State Milton S. Hershey Medical CenterHershey, Egyesült Államok

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A vizsgálat 2 csoportja

  • InterventionA vizsgált kezelés

    Oral naltrexone, to start as 25mg for three days then 50mg a day for 6 weeks. Oral naltrexone generic tabs will be blinded in opaque gelatin capsules with methylcellulose filler

    Kezelés: Naltrexone Hydrochloride

  • ControlPlacebo, összehasonlításként

    Opaque gelatin capsules with methylcellulose filler, taken by mouth once a day for six weeks

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Double-Blind Placebo-Controlled Evaluation of Effectiveness of Oral Naltrexone in Management of Adolescent Eating Disorders
A regiszteradat frissítve
2025. augusztus 19.