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临床试验/NCT03414112
NCT03414112已完成早期 1 期

Investigating the Impact of Oxytocin on the Neurobiological Underpinnings of Socioemotional Deficits in Anorexia Nervosa

University of Minnesota2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年9月25日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
16
试验地点
2
主要终点
Test meal

研究概览

简要总结

This study will use a randomized, controlled, double-blind design involving the administration of intranasal oxytocin (INOT) or placebo to adults with anorexia nervosa, restricting subtype and age-matched controls prior to neuroimaging to assess the impact on frontolimbic brain activity in response to socioemotional stimuli as well as eating behavior in a test meal paradigm.

详细描述

The primary objective of this investigation is to determine the impact of oxytocin (OT), a peptide hormone that influences social affiliation, on socioemotional neural circuitry and eating disorder behavior in anorexia nervosa (AN). Because socioemotional processing deficits appear to play a key role in AN, OT is implicated as a potential biological mechanism by which eating disorder behavior (e.g., restrictive eating) is maintained. Used as a probe, intranasal oxytocin (INOT) provides an innovative method for examining the short-term impact of OT on socioemotional neural processing disturbances and eating disorder behavior in AN. The proposed study tests a theoretical model of the role of OT in the maintenance of AN by using an INOT probe to determine, and potentially alter, neurobiological responses to socioemotional stimuli. Specifically, this study will use a randomized, controlled, double-blind design involving the administration of INOT or placebo to adults with AN restricting subtype and age-matched controls prior to neuroimaging to assess the impact on frontolimbic brain activity in response to socioemotional stimuli. The potential impact of INOT on restrictive eating will also be assessed in a subsequent test meal. We predict that for participants with AN, INOT, but not placebo, will normalize frontolimbic activation in response to social reward stimuli and prefrontal activation in response to social threat stimuli. In addition, the investigators predict that AN participants will display reduced restrictive eating in a test meal paradigm following INOT (but not placebo) administration. Finally, investigators predict that changes in restrictive eating following INOT administration will be mediated by altered frontolimbic responding to socioemotional cues. This investigation will provide an essential link uniting the data supporting the importance of socioemotional processing deficits in AN with the emerging role of INOT in altering the neural circuits involved in social behavior to test an innovative neurobiological maintenance model of AN.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

The study will be double blind; participants and study staff will not know if the participant is receiving intranasal oxytocin or placebo.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • All participants:
  • Age > 18 years old
  • Female (given the potential sex differences to endogenous OT to INOT)
  • Ability to read and speak in English
  • Right-handed
  • Anorexia nervosa participants:
  • DSM-5 diagnosis of AN, restricting subtype (established by the SCID-5-RV),
  • BMI < 18.5 kg/m2 within the past month

排除标准

  • All participants
  • Medical instability or current pregnancy or lactation
  • Current substance use disorder, psychosis, or bipolar-I disorder
  • Contraindication for fMRI (e.g., implanted metal)
  • History of neurological disorder/injury (e.g., stroke; head injury with > 10 minutes loss of consciousness)
  • Food allergy that cannot be accommodated through substitutions to the laboratory test meal
  • Lacking capacity to consent
  • Contraindications for intranasal oxytocin administration
  • Acute suicidality
  • Psychoactive medication (e.g., antidepressants, antipsychotics)
  • Exclusion for participants without anorexia nervosa
  • Current DSM-5 Axis-I diagnosis or current or past eating disorder diagnosis
  • BMI < 19.0

结局指标

主要结局

Test meal

时间窗: Following intranasal oxytocin or placebo (within 1-3 hours)

Participants will complete a test meal

fMRI measures

时间窗: Following intranasal oxytocin or placebo administration (within 1-3 hours)

Neural activation in regions of interest (ROIs) in socioemotional circuitry (i.e., ACC, amygdala, medial PFC, NAcc) in response to INOT or placebo and social threat vs. neutral tasks and social reward vs. neutral stimuli

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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