Neural Circuits in Women With Abuse and Posttraumatic Stress Disorder
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score
研究概览
简要总结
The purpose of this study was to assess the effects of the medication paroxetine on symptoms of posttraumatic stress disorder (PTSD) and the brain in women with a history of PTSD related to childhood abuse. The hypothesis is that paroxetine will result in an improvement in PTSD symptoms accompanied by changes in brain functional response to reminders of childhood trauma.
详细描述
The main purpose of this study was to look at the effects of paroxetine on PTSD symptoms and brain function in women with posttraumatic stress disorder (PTSD) related to childhood abuse. Participants underwent baseline assessment with of PTSD symptoms measured with the Clinician Administered PTSD Scale (CAPS) and brain function during exposure to traumatic scripts of childhood abuse. Participants then were treated in a randomized double-blind fashion with paroxetine or placebo for three months, followed by a repeat of these assessments.
Specific Aims of this proposal were therefore to:
- Assess the effects of paroxetine on PTSD symptoms
- Assess the effects of paroxetine on brain function in conjunction with exposure to traumatic scripts using positron emission tomography (PET) with O-15 water
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subjects meet criteria for current PTSD as determined by the Structured Clinical Interview for DSMIV (SCID) interview for PTSD and the Clinician Administered PTSD Scale (CAPS) and have a score of greater than 60 on the CAPS
- •history of penetrative sexual abuse which occurred once a month or more, for a period of greater than a year at some time between the ages of 4-13, as assessed by the Early Trauma Inventory (ETI)
- •are free of psychotropic medication for four weeks before the study (subjects will not be taken off of medication for the purpose of the study).
- •Non-PTSD subjects will be included based on the same criteria with the exception that they do not meet criteria for PTSD.
排除标准
- •a history of shrapnel or other foreign bodies which would preclude MRI scanning
- •meningitis
- •traumatic brain injury
- •neurological disorder or organic mental disorder
- •history of loss of consciousness
- •alcohol abuse or substance abuse or dependence based on the SCID within the past 24 months
- •positive pregnancy test as measured by a serum beta-HCG or urine pregnancy test on the morning of the PET scan. Women will be counseled about the risks of pregnancy during the course of the study
- •current or lifetime history of schizophrenia, schizoaffective disorder, or bulimia, based on the SCID
- •a history of serious medical or neurological illness, such as cardiovascular, gastrointestinal, hepatic, renal, neurologic or other systemic illness
- •evidence of a major medical or neurological illness on physical examination or as a result of laboratory studies (CBC, BUN, creatinine, blood sugar, electrolytes, liver and thyroid function tests, urinalysis, and EKG)
- •positive urine toxicology screen
- •history of ongoing violence such as domestic abuse as measured by the ETI-lifetime
- •post-menopausal status as measured by menstrual history.
- •Non-PTSD subjects will additionally be excluded with current major depression or other major psychiatric disorder based on the SCID.
研究组 & 干预措施
Paroxetine Group
Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.
干预措施: Paroxetine (Drug)
Paroxetine Group
Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive paroxetine for a three month period followed by an open label phase of three months.
干预措施: Positron Emission Tomography (PET) Imaging (Other)
Placebo Group
Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
干预措施: Placebo (Drug)
Placebo Group
Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
干预措施: Paroxetine (Drug)
Placebo Group
Women who have experienced early childhood abuse and have PTSD will be randomized in a double blind fashion to receive placebo for a three month period followed by an open label phase of paroxetine for three months.
干预措施: Positron Emission Tomography (PET) Imaging (Other)
PTSD Negative
Women who have experienced early childhood abuse and do not have PTSD will serve as a control group and complete baseline assessments. They do not undergo intervention therefore they are assessed at baseline only.
干预措施: Positron Emission Tomography (PET) Imaging (Other)
结局指标
主要结局
Mean Clinical Administered PTSD Scale for DSM-IV (CAPS) Score
时间窗: Baseline, End of Study (Up to 52 Weeks)
The CAPS is a 30-item questionnaire of PTSD symptomatology that provides continuous measures of symptom severity and frequency. CAPS-IV total symptom severity score is calculated by summing severity scores for the 17 DSM-IV PTSD symptoms. Each symptom is rated for severity based on frequency and intensity on a scale of 0-4 for a total possible severity score per symptom of 8. Criterion E (items 18-19) is duration of symptoms (minimum of one month to make the diagnosis). Items 20-30 are optional. CAPS score is based on items 1-17, CAPS score has a potential range of 0-136, with higher scores indicating greater severity of PTSD symptoms. CAPS was performed before and after treatment with paroxetine or placebo in PTSD patients.
次要结局
- Change in Brain Blood Flow Assessed by Statistical Parametric Mapping (SPM)(Baseline, 3 Months Post Treatment)
研究者
J. Douglas Bremner, M.D.
Professor of Psychiatry and Radiology
Emory University