Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Symptom Checklist 90 scale (SCL-90-R)
研究概览
简要总结
Objective:
The objective of this study is to quantitatively examine the efficacy of Seroquel (active ingredient quetiapine fumarate) in subjects with Borderline Personality Disorder (BPD). A secondary objective is to characterize the safety and tolerability of utilizing quetiapine in patients with Borderline Personality Disorder.
Design:
Investigator initiated, 6-week, non-placebo controlled, non-randomized, open-label, single drug, single-center, medication trial.
Participants:
Volunteers (n = 15) diagnosed with Borderline Personality Disorder using the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II).
Interventions:
Subjects with Borderline Personality Disorder are washed out of all other medications. The subjects are then given the study drug at a dose within the drug's known therapeutic range.
详细描述
Study Design: A six week, open-label, flexible dosing study using quetiapine. Subjects who qualify at Screening will then proceed to the baseline visit. If all inclusion and exclusion criteria are met, subjects will be administered quetiapine at the baseline visit. Enrollment will be 15 subjects. Enrollment is expected to last for a 6 month period.
Study Flow Sheet
Duration of Study and Visit Schedule. The subjects will have visits at the following intervals:
- Screening (Day -1 to -14)
- Visit 1 (Baseline)
- Visit 2 (Week 1)
- Visit 3 (Week 2)
- Visit 4 (Week 3)
- Visit 5 (Week 4)
- Visit 6 (Week 5)
- Visit 7 (Week 6)
Screening visit (Day -1 to -14): The following procedures will be performed:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provide written informed consent before beginning any study related activities
- •Be between age 18 and 55 years
- •Be able to speak, read and write English and follow simple instructions for completing self-rated scales
- •Meet DSM-IV criteria for BPD as assessed by the Structured Clinical Interview for DSM-IV Personality Disorders (SCID-II).
排除标准
- •Are pregnant or lactating.
- •Have participated in any other studies involving investigational products within 30 days prior to entry into this study.
- •Are undergoing an acute withdrawal syndrome from drugs or alcohol.
- •Have an Axis I diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or Bipolar I Disorder as diagnosed by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), and pertinent subsequent for ruling out exclusionary diagnoses.
- •Have an unstable medical disorder as determined by physical examination or laboratory testing. The primary investigator will be responsible for making this judgment based on the above.
- •Had an unsatisfactory response to a previous adequate trial of quetiapine as judged by a study investigator.
- •Patients cannot begin psychotherapy during the study period, but may continue if started prior to the study.
- •Patients who are currently receiving quetiapine therapy may not undergo a washout period and then restart quetiapine in the study.
研究组 & 干预措施
A
Quetiapine at dosage of 50 to 150 mg
干预措施: Quetiapine Fumarate (Drug)
结局指标
主要结局
Symptom Checklist 90 scale (SCL-90-R)
时间窗: 8 weeks
次要结局
- Safety and tolerability will be measured at Baseline and weekly using the following scales: Simpson-Angus Extrapyramidal Side Effect Scale (SAS), Barnes Akathisia Scale (BAS), and Abnormal Involuntary Movement Scale (AIMS).(8 weeks)