Does Fluoxetine Reverse the Effects of Early Life Stress on the CNS Corticotropin-Releasing Factor System and Improve Psychological and Neuroendocrine Function?: A Therapy Outcome Study in Women With Childhood Abuse Experiences
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF
研究概览
简要总结
The primary objective of this project is to determine whether treatment with the SSRI, fluoxetine versus placebo reverses alterations in the central CRF system induced by early life stress experiences (i.e. childhood sexual and/or physical abuse) in cases with and without major depression. We also evaluate whether neuroendocrine changes after SSRI treatment correlate with clinical improvement.
详细描述
We compare indices of central CRF activity (i.e. ACTH and cortisol response to CRF stimulation test) before and after 8 weeks of treatment with either fluoxetine or placebo between women with a history of childhood abuse (early life stress, ELS) and current major depression (ELS/MDD), women with a history of childhood abuse without major depression (ELS/non-MDD), and women without a history of childhood abuse and major depression (non-ELS/MDD). Changes in neuroendocrine responses to CRF are correlated with psychological outcome measures. We hypothesize that treatment with fluoxetine will normalize altered neuroendocrine responsiveness in cases with ELS and that this normalization will be correlated with improvement of symptoms of depression and anxiety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •For all subjects female gender;
- •For subjects assigned to the MDD groups, current DSM-IV diagnosis of MDD;
- •For subjects assigned to the early-life stress group, repeated (once per month or more for at least year) sexual or physical abuse before the age of 12 years by a perpetrator at least 5 years older at the time;
- •For all subjects, age of 18 to 45 years;
- •Regular menstrual cycle and assessment in the early follicular phase as verified by sex steroid measures.
排除标准
- •For all subjects, gender identity disorders;
- •For all subjects assigned to non-MDD groups, DSM-IV diagnosis of current MDD;
- •For all subjects assigned to the group without early-life stress, major stress experiences before the age of 12 years, such as separation from parents, neglect, parental loss, accidents, severe illness or natural disaster;
- •For all subjects, significant medical illness, such as gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease, organic brain disease, or cancer as determined by history, physical examination, ECG, and laboratory tests;
- •Pregnancy or nursing;
- •For all subjects, past or current presence of psychotic symptoms or bipolar disorder;
- •For all subjects, current presence of psychoactive substance abuse/dependency or eating disorders;
- •For all subjects, hormonal medication;
- •For all subjects, psychotropic medication in the four weeks prior to study entry;
- •For all subjects, inability to provide informed consent.
结局指标
主要结局
Plasma ACTH and cortisol concentrations before and after administration of 1 microgram per kg ovine CRF
时间窗: 6 hours
次要结局
- Symptom Rating Scales for Depression, Anxiety and PTSD as well as general well-being(8 weeks)