Double-Blind, Randomized, Placebo-Controlled, Cross-Over Study of Intranasal Oxytocin Augmentation of Antidepressant Medication in Depressed Patients.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Total Score on Montgomery-Asberg Depression Rating Score (MADRS)
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 depression symptoms in patients with Major Depressive Disorder (MDD) or Dysthymia Disorder.
详细描述
Depression patients treated with even the best currently available antidepressant drugs continue to experience significant symptoms. There is a strong need for better treatments including treatments that can safely be given adjunctively with concurrent antidepressants in order to improve overall efficacy of treatment.
Oxytocin is a neurohypophyseal peptide best known for its role as a neurohormone involved in parturition and lactation. In addition to these well established peripheral effects, there is a compelling body of converging evidence indicating that oxytocin plays a critical role in the regulation of a number of diverse centrally-mediated behavioral and cognitive processes that are highly relevant to mood regulation and mood disorders, including social attachment (Argiolas and Gessa 1990; McCarthy and Aaltemus 1997).
Each subject will be enrolled for a 8 week treatment period after a screening phase. Study procedure involves weekly clinic visits as an outpatient. Twenty patients will be randomly assigned to either 40 IU oxytocin twice daily or vehicle placebo. After 4 weeks, treatments will be crossed over such that subjects that received oxytocin will receive placebo and vice versa. The study ratio is 1:1. Dose of oxytocin is based upon previous studies in humans showing improvement in psychiatric populations related changes in behavior and brain function (Kosfeld et al, 2005; Kirsch 2005; Heinrich M 2003).
The total study duration for each individual subject will be approximately 9 weeks, which includes up to 31-day screening period, a baseline (randomization) visit, four week treatment period, 1 week washout, baseline 2 visit, and four weeks cross over treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men or women, 18 years of age or older.
- •Meet DSM-IV criteria for Major Depressive Disorder or Dysthymia Disorder
- •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 1 or 2 antidepressants with no major dose changes for at least 4 weeks at randomization.
- •MADRS score of >17 at randomization
- •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. (If patient cannot then he/she will be considered for the acute only portion of this study.)
- •Subjects on up to 2 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 is acceptable. Patients will be asked to notify the study doctor of any changes to sleep aids.
排除标准
- •Subjects will be excluded from the study of they meet any of the following criteria:
- •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 Major Depressive Disorder or Dysthymia Disorder
研究组 & 干预措施
Oxytocin
20 IU of intranasal oxytocin twice per day for the first week, 40 IU of intranasal oxytocin twice per day for the following 3 weeks, one week wash out, 4 week placebo trial.
干预措施: Oxytocin (Drug)
Placebo
Four week placebo trial, one week wash out, 20 IU of intranasal oxytocin twice per day for one week, 40 IU of intranasal oxytocin twice per day for 3 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Total Score on Montgomery-Asberg Depression Rating Score (MADRS)
时间窗: Performed at each visit (weekly)
The MADRS is a clinician-rated assessment used to measure the severity of depressive episodes in patients with mood disorders. The measure contains 10 items and each item is scored in a range of 0 to 6 points, with higher score indicating increased depressive symptoms.
次要结局
- Profile of Mood States (POMS)(Performed at the beginning and end of each treatment arm)
- Global Assessment of Functioning (GAF)(Performed at each visit (weekly))
- Clinical Global Impression-Severity of Illness (CGI-S)(Performed at each visit (weekly))
- Clinical Global Impression-Global Improvement (CGI-I)(Performed at each visit (weekly))
- Young Mania Rating Scale (YMRS)(Performed at each visit (weekly))
- Hamilton-Anxiety Scale (HAM-A)(Performed at each visit (weekly))
- Reading Trust in the Mind's Eye Test(Performed at the beginning and end of each treatment arm.)
- Arizona Sexual Experience Scale (ASEX)(Performed at each visit (weekly))
- Peabody Picture Vocabulary Test(Performed at the beginning of the study)
- California Verbal Learning Test(Performed at the beginning and end of each treatment arm)
- Letter Number Sequencing Memory Test(Performed at the beginning and end of each treatment arm)
- Continuous Performance Test (CPT)(Performed at the beginning and end of each treatment arm)
研究者
David Feifel
Professor
University of California, San Diego