A Study of the Effects of Oxytocin in Adults With Binge-eating Disorder

Официальное название

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effects of Intranasal Oxytocin in Adults With Binge-eating Disorder

Обзор

This study evaluates the impact of intranasal oxytocin vs placebo in patients with binge eating disorder or episodes of binging. We hypothesize that 8 weeks of intranasal oxytocin vs placebo will improve clinical outcomes \[reduction in bingeing frequency\], and have a satisfactory safety and tolerability profile. We will also explore the predictive value of changes in homeostatic appetite, reward sensitivity, and impulse control, the identified underlying mediators, as assessed 4 weeks into the intervention, for treatment success after 8 weeks of the intervention.

Подробное описание

Study staff will screen patients for eligibility as per eligibility criteria. At least 60 eligible patients will be randomized 1:1 (active oxytocin: placebo) by an unblinded pharmacist. All other study staff and test subjects will be blinded. Study subject medical histories, physical exams, anthropometric measurements, labs, EKG's, and eating habits will be monitored over 8 weeks. Subjects will be evaluated at the following intervals: Baseline, week 2, week 4, week 8, and week 16 (8 weeks post-treatment).

Вмешательства

• Препарат TNX-1900 (Tonix Pharmaceuticals)
  oxytocin nasal spray
• Препарат Placebo
  Nasal solution without oxytocin

Первичные конечные точки

• Binge Frequency [Срок оценки: 8 weeks]

Вторичные конечные точки (2)

• Reward sensitivity [Срок оценки: 8 weeks]
• Impulse control [Срок оценки: 8 weeks]

Критерии участия

Критерии включения

• Males and females, 18-70 years old
• BMI greater than or equal to 18.5
• BED as assessed by Structured Clinical Interview for DSM-5 Disorders (SCID-5-RV) OR Other Specified Feeding or Eating Disorder (OSFED) - Binge-eating disorder (of low frequency and/or limited duration) (SCID-5-RV) OR Bulimia Nervosa (BN) through excessive exercise and/or fasting to avoid gaining weight after episodes of binge eating. For individuals with OSFED-BED, the frequency of subjective and objective binge eating episodes will meet the frequency (Criterion D) for BED.

Критерии исключения

• Substance use disorder active within the last 6 months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at the time of screening based on history and/or laboratory results
• Medication changes that have not reached steady state concentration, measured by the equivalent of 5 half-lives of that medication
• Use of medications for binge eating disorder or weight loss unless at a stable dose for at least 12 weeks
• History of any of the following medical conditions: inflammatory bowel disease or untreated thyroid disease
• Uncontrolled epilepsy (as defined by a seizure within the last 12 months)
• Clinically relevant ventricular arrhythmias, coronary heart disease, known long QTc, and hypertrophic cardiomyopathy
• Hematocrit >2% below normal
• Hemoglobin A1c >8%
• Use of insulin
• ALT or AST >2.5 times upper limit of normal
• Glomerular filtration rate < 60 mL/min
• Hyponatremia. Note that, in order to be randomized, subjects must have Na ≥ 135 mEq/L.
• Pregnancy or breastfeeding
• Unwilling to use a medically acceptable form of contraception throughout the study period (female of child-bearing potential only)
• History of psychosis or active suicidal ideation
• Major depressive disorder likely to require initiation or change in active treatment
• Borderline personality disorder as assessed by the McLean Screening Instrument for Borderline Personality Disorder (MSI-BPD)
• Current nicotine use, unless stable use for at least 12 weeks.
• Participation in any clinical study involving an investigational drug, device, or biologic within 1 month of randomization
• Any significant illness, condition, or medication that the Investigator determines could interfere with study participation and impact data collection or subject safety

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Neuroendocrine Unit Research Center — Boston

Идентификаторы

NCT: NCT05664516 · 2022P002727

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗