Antipsychotic Effects of Oxytocin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint
研究概览
简要总结
The objective of the study is to compare the efficacy of intranasal oxytocin versus intranasal placebo to improve symptoms in schizophrenia patients who have residual symptoms despite being on adequate treatment with antipsychotic medication.
详细描述
This is two-site clinical study taking place at UCSD and UCI. Approximately 71 patients at each site will be randomly assigned to either intranasal oxytocin or vehicle placebo at this site.
The total duration for each individual subject will be 6 weeks on study medication (placebo or oxytocin).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women, 21 years of age or older.
- •Meet DSM-IV criteria for Schizophrenia.
- •Women of childbearing potential must test negative for pregnancy at the time of enrollment based on urine pregnancy test and agree to use a reliable method of birth control during the study.
- •Must be on a therapeutic dose of an atypical antipsychotic medication (examples but not limited to Clozapine Olanzapine, Risperidone, Ziprasidone, Aripiprazole, Seroquel) with no major dose changes for at least 4 weeks.
- •A minimum PANSS total score of 55 at screening and baseline and a score of at least 4 (moderate) on the subscale of the PANSS (suspiciousness/persecution) at screening.
- •Have a Clinical Global Impressions-Severity (CGI-S) scale score of at least 4 (moderately ill) at baseline.
- •Must be able to communicate effectively with the investigator and study coordinator and have the ability to provide informed consent.
- •Must be able to use nasal spray.
- •Must demonstrate an acceptable degree of compliance with medication and procedures in the opinion of the investigator.
排除标准
- •Are pregnant or are breastfeeding (negative pregnancy test at screening).
- •A urine drug screen performed at screening must not show evidence of recent use of drugs of abuse.
- •Any active medical condition that in the opinion of the investigator will interfere with the objectives of the study.
- •Are unsuitable in any way to participate in this study, in the opinion of the investigator.
- •Another current DSM-IV diagnosis other than Schizophrenia.
- •Subjects on one SSRI, and/or sleep medication (diphenhydramine, zolpidem, zaleplon, or diazepam), at a reasonable dose, as judged by the investigator, is permitted in this study. Minor adjustments in sleep medication are acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.
研究组 & 干预措施
Oxytocin: Low Dose
42 IU BID for the six weeks
干预措施: Oxytocin (Drug)
Oxytocin: High Dose
84 IU BID for six weeks
干预措施: Oxytocin (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Score in the Positive and Negative Syndrome Scale (PANSS)From Baseline to Endpoint
时间窗: 6 weeks
The three subscales of the PANSS include the Positive scale (7 items), the Negative scale (7 items), and the General Psychopathology scale (16 items). The total PANSS score is the sum of all 30 items of which each item is scored on a 1-7 rating system (7 indicating the worst symptoms). The items on the PANSS focus on symptoms that are common in patients with psychotic disorders and include hallucinations, delusions and disorganization as well as mood disturbances.
次要结局
- Global Assessment of Functioning (GAF)(6 weeks)
- Clinical Global Impression-Severity of Illness (CGI-S)(6 weeks)
- Clinical Global Impression-Global Improvement (CGI-I)(6 weeks)
- Computerized Multiphasic Interactive Neurocognitive DualDisplayTM System (CMINDS®)(6 weeks)
- Mayer-Salovey-Caruso Emotional Intelligence Test: Managing Emotions (MSCEIT™ ME)(6 weeks)
- Calgary Depression Scale for Schizophrenia (CDSS)(6 weeks)
- Hamilton-Anxiety Scale (HAM-A)(6 weeks)
- Treatment Satisfaction Questionnaire for Medication (TSQM)(6 weeks)
- Penn Emotion Recognition Test (ER-40)(6 weeks)
- Paranoid Thoughts Scale (PTS)(6 weeks)
- Childhood Trauma Questionnaire (CTQ)(6 weeks)
- Experience Close Relationships (ECR)(6 weeks)
- Arizona Sexual Experience Scale (ASEX)(6 weeks)
- Social Phobia Inventory (SPIN)(6 weeks)
研究者
David Feifel
Professor of Psychiatry and Neurosciences Program Director, Neuropsychiatry and Behavioral Medicine Program Director, UCSD Adult ADHD Program
University of California, San Diego