A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.
研究概览
简要总结
The purpose of this study is to compare the response of veterans with PTSD without an optimal response to paroxetine to quetiapine augmentation versus placebo.
详细描述
This is a two-site study designed to evaluate the efficacy and safety of quetiapine augmentation of paroxetine treatment in veterans with PTSD who have failed to respond to paroxetine treatment.
In Phase I, eligible patients will take open-label paroxetine (up to 60 mg daily) for 8 weeks. Patients who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for the second phase. In Phase II, patients will continue taking open-label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) or placebo for 8 weeks in a double-blind fashion.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Veteran age 18 to
- •Competent to give informed consent.
- •Meeting DSM-IV criteria for PTSD.
- •Minimal CAPS score of 50 at baseline.
- •If female of childbearing potential, patient must have a negative pregnancy test and, if sexually active, be using a medically approved contraceptive method.
- •Patients who have not taken psychiatric medications within 1 week prior to study entry (except fluoxetine [5 weeks])
- •monoamine oxidase inhibitors (MAOIs [4 weeks])
- •depot neuroleptics [4 weeks])
- •or any investigational drug within 30 days prior to study enrollment.
- •To be eligible for Phase II
- •patients must be refractory to paroxetine in Phase I, as defined by less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8
- •must have PTSD symptoms at least moderate severity on CGI-S
- •and must have been compliant with study medicine in Phase I, as defined by taking at least 80% of prescribed doses.
排除标准
- •History of sensitivity to paroxetine or quetiapine.
- •Failure to respond to a prior adequate therapeutic trial i.e. minimum of 8 weeks at maximum tolerated dose of paroxetine (up to 60 mg daily) or quetiapine (up to 800 mg daily).
- •Women who are
- •breast-feeding
- •expect to become pregnant during the course of the study
- •or are sexually active and are not using a medically acceptable method of birth control.
- •Presence of clinically significant hepatic
- •cardiovascular
- •or other medical conditions that may prevent safe administration of paroxetine or quetiapine
- •or any other clinically significant unstable medical conditions.
研究组 & 干预措施
Arm 1: Open Label (OL) Paroxetine
Open-label Paroxetine In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.
干预措施: Open Label (OL) Paroxetine (Drug)
Arm 2 OL Paroxetine + DB Placebo
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.
干预措施: Open Label (OL) Paroxetine (Drug)
Arm 2 OL Paroxetine + DB Placebo
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.
干预措施: Placebo (Drug)
Arm 3: OL Paroxetine + DB Quetiapine
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
干预措施: Open Label (OL) Paroxetine (Drug)
Arm 3: OL Paroxetine + DB Quetiapine
In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.
干预措施: Quetiapine (Drug)
结局指标
主要结局
Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.
时间窗: From baseline (week 8) to endpoint (week 16 or termination)
The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change.
次要结局
- Change in CGI-I(From Baseline (week 8) to Endpoint (week 16 or termination))
- Change in Mean PANSS Total and Subscores From Baseline to Endpoint(Baseline (week 8) to Endpoint (week 16 or termination))
- Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores(From Baseline (week 8) to Endpoint (week 16 or Termination))
- Change in Total Mean Davidson Trauma Scale (DTS)(From Baseline (week 8) to Endpoint (week 16 or Termination))
- Change in Mean Q-LES-Q Score From Baseline to Endpoint.(From Baseline (week 8) to Endpoint (week 16 or termination))
- Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint.(From Baseline (week 8) to Endpoint (week 16))
- Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint.(Baseline (week 8) to Endpoint (week 16 or termination))
- Change in Arizona Sexual Experience Scale (ASEX)(From Baseline (week 8) to Endpoint (week 16 or termination))