Effects of Oxytocin on Familial Interactions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in Negative Expressed Emotion
研究概览
简要总结
The purpose of the investigators proposed study is twofold: 1) To investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic system positively influences these family interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion criteria for caregiver of patients with schizophrenia, patients with autism spectrum disorder, and healthy controls:
- •Age between 18 and 75 years old
- •Must have at least 4 hours of contact with the patient per week and be considered a "significant caregiver" by the patient
- •Inclusion criteria for patients with schizophrenia:
- •Between the ages of 14 and
- •Patients must have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis- Not Otherwise Specified (NOS).
- •Patients must be clinically stable
- •No or minor changes to medications in the past week
- •Patients must have a primary caregiver
- •Inclusion criteria for healthy control child:
- •Between the ages of 14 and 45
- •Healthy control must have a primary caregiver
- •Inclusion criteria for patients with autism spectrum disorder
- •Between the ages of 14 and 45
- •Patient must have a primary caregiver
- •Patients must have a diagnosis of an autism spectrum disorder (ASD) (autism or Asperger's disorder), pervasive developmental disorder (PDD) or pervasive developmental disorder - not otherwise specified (PDD-NOS).
排除标准
- •Exclusion criteria for all caregivers:
- •Female caregivers that state that they are pregnant or have a positive urine pregnancy test
- •Caregivers who have significant nasal pathology, atrophic rhinitis, recurrent nose bleeds, or history of cranial-surgical procedures (hypophysectomy)
- •Caregivers with significant psychiatric, neurologic, or medical illness
- •Exclusion criteria for healthy controls:
- •Healthy controls with history of psychiatric or neurological illness
- •Exclusion criteria for patients with an autism spectrum disorder:
- •Patients with an Intelligence Quotient (IQ) lower than 75
- •Exclusion criteria for patients with schizophrenia
- •Patients with severe brain trauma
研究组 & 干预措施
Placebo
Saline Nasal Spray
干预措施: Placebo Comparator (Other)
Oxytocin
40 IU Oxytocin Intranasal
干预措施: Oxytocin (Drug)
结局指标
主要结局
Change in Negative Expressed Emotion
时间窗: Continuously for 4 hours after drug adimistration
We will measure the number of times caregivers show parental criticism, hostility, lack of warmth and emotional over-involvement.
次要结局
未报告次要终点
研究者
Joshua Woolley
Assistant Professor in Residence
University of California, San Francisco