NCT00237393已完成4 期
A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
研究概览
简要总结
The purpose of the study is to determine if quetiapine is effective in the treatment of PTSD.
详细描述
Objective
To assess the impact of quetiapine on core PTSD symptoms and associated psychiatric comorbidity including depressive and positive and negative psychotic symptoms.
Research Design: 12-week, double-blind, placebo-controlled, randomized, fixed-flexible dose trial of quetiapine monotherapy.
Intervention: Eligible patients will be randomized to receive quetiapine starting at 25 mg daily or matching placebo. Dose adjustments (to a minimum of 50 mg or a maximum of 800 mg), will be made at the investigator's discretion and according to patient's clinical response.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 years of age or older of any ethnic background meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for PTSD.
- •Score of at least 50 on the CAPS-SX at baseline.
- •Competent to give informed consent.
- •If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential.
- •Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the randomized phase.
- •Other medications, if any, must have been kept stable for at least one month prior to randomization.
排除标准
- •History of sensitivity to quetiapine
- •Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to randomization and throughout the study period.
- •Medical conditions that may prevent safe administration of quetiapine including clinically significant hepatic, cardiac, or pulmonary disease.
- •Medical disorders that may cause or exacerbate anxiety symptoms.
- •Alcohol or drug abuse or dependence within one month of study entry as defined by DSM-IV criteria.
- •Schizophrenia, schizoaffective disorder, or bipolar disorder.
- •Suicidal or homicidal ideation or other clinically significant dangerousness
- •Currently seeking compensation or increase in compensation for the effects of the trauma.
- •Initiation or change in psychotherapy within 3 months of randomization.
研究组 & 干预措施
1
Experimental
Quetiapine
干预措施: Quetiapine (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Global scores on Clinician Administered PTSD Scale - One Week Symptom Version (CAPS-SX) at week 12
次要结局
- Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)
- Davidson Trauma Scale (DTS)
- Week 12 scores on Positive and Negative Syndrome Scale (PANSS)
- Clinical Global Impression Severity Scale (CGI-S)
- Clinical Global Impression Improvement Scale (CGI-I)
- Pittsburgh Sleep Quality Inventory/Pittsburgh Sleep Quality Inventory Addendum (PSQI/PSQI-A)
- SDS
- AIMS
- SAS
- Hamilton Depression Rating Scale (HAMD)
- Hamilton Rating Scale of Anxiety (HAMA)
- BAS
- Arizona Sexual Experience Scale (ASEX)
研究者
研究点 (2)
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