Aripiprazole Augmentation of Antidepressants in PTSD
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
The proposed investigation will determine the therapeutic potential of aripiprazole augmentation to a stable antidepressant regimen for reducing posttraumatic stress disorder (PTSD) symptoms, cognitive symptoms, psychotic symptoms, and depressive symptoms in veterans with PTSD.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Outpatient veterans with posttraumatic stress disorder (PTSD)
- •Receiving treatment with an antidepressant at a stable dose for 4 weeks
- •Male or female
- •Ages 18-65 years old
排除标准
- 未提供
研究组 & 干预措施
Aripiprazole
干预措施: Aripiprazole (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS)
时间窗: Week 2 and Week 6
Mean change scores (Week 2 minus Week 6) in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
Brief Assessment of Cognition in Affective Disorders (BAC-A)
时间窗: Week 2 and Week 6
The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3. Mean change scores from week 2 and week 6 (Week 2 minus Week 6).
Positive and Negative Symptoms Scale (PANSS)
时间窗: Week 2 and Week 6
The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.Mean change scores from Week 2 and Week 6 (Week 2 minus Week 6)
次要结局
- Connor-Davidson Resilience Scale (CD-RISC)(Week 2 and Week 6)
- Beck Depression Inventory, Second Edition (BDI-II)(Week 2 and Week 6)