Effects of Intranasal Oxytocin on Satiety Signaling in People With Schizophrenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Food Consumption After Intervention
研究概览
简要总结
The objective of this study is to test a single dose of intranasal oxytocin, compared to placebo, in a within subjects, crossover design, to see if oxytocin will improve satiety signaling (behaviorally and/or by self report) compared to placebo. If this single dose pilot paradigm shows an increase in satiety, it may be tested in follow-up studies as a prevention or treatment for weight gain and overeating in people with schizophrenia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 54 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-IV diagnosis of schizophrenia or schizoaffective disorder
- •Male or Female
- •Age: 18 to 54 years
- •Caucasian or Non-Caucasian
- •Body Mass Index of ≥ 27 kg/m2
- •One month of stable antipsychotic treatment (same medication regimen and same dose)
排除标准
- •History of organic brain disease
- •DSM-IV diagnosis of Mental Retardation
- •DSM-IV diagnosis of Alcohol or Substance Dependence within the last six months (except nicotine)
- •DSM-IV diagnosis of Alcohol or Substance Abuse within the last one month (except nicotine)
- •Are pregnant or lactating
- •Meet DSM-IV criteria for a past and/or current eating disorder via the SCID, or if they have a past medical history of an eating disorder, received treatment/counseling for an eating disorder and/or required hospitalization for an eating disorder. (If an otherwise undiagnosed eating disorder is detected during screening, referral to treatment will be provided.)
- •Are taking weight-loss medications, whether over-the-counter (i.e. Hydroxycut, Stacker products, Metabo-Plus, CortiSlim), or prescribed, including appetite suppressants (Didrex, Tenuate, Sanorex, Mazanor, Adipex-P, Meridia, and Phentermine) and fat-absorption inhibitors (Xenical).
- •Have cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC).
- •Have a medical illness, dietary restrictions, or food allergies that, in the view of the investigators, would compromise participation.
- •Are taking prostaglandins such as dinoprostone or misoprostol (because they interact with oxytocin).
研究组 & 干预措施
Oxytocin/Placebo
Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
干预措施: Oxytocin (Drug)
Oxytocin/Placebo
Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
干预措施: Placebo (Drug)
Placebo/Oxytocin
Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
干预措施: Oxytocin (Drug)
Placebo/Oxytocin
Each participant will receive intranasal oxytocin 24IU or intranasal saline 24IU in random order. All results will be reported by treatment, the sample is too small for order effects.
干预措施: Placebo (Drug)
结局指标
主要结局
Food Consumption After Intervention
时间窗: 90 minutes
We hypothesize that participants will have greater satiety signaling, indicated by less consumption of the "Test Meal" consumed 90 minutes after the preload.
次要结局
未报告次要终点
研究者
MPRC
Dr. Kimberly Warren
University of Maryland, Baltimore