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

RecruitingPhase 2Ages 18 Years - 70 YearsAllMassachusetts General Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 โ‰ฅ 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
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What it tests

  • TNX-1900 (Tonix Pharmaceuticals)
  • Placebo
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Where

1 site
Neuroendocrine Unit Research Center
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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