A Double-Blind, Placebo-Controlled Random Order Crossover Study of Iloperidone for Symptoms of Arousal in PTSD Including Insomnia and Irritability.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Change in Clinician Administered PTSD Scale (CAPS) Part B and D
研究概览
简要总结
A Double-Blind Placebo-Controlled Random Order Crossover Pilot Study of Iloperidone for Symptoms of Arousal in PTSD.
详细描述
During Period A, subjects will receive 8 weeks of iloperidone or placebo (2 weeks titration period followed by 6 weeks on stable dose). Then they will be reassessed for response during Period A; study drug will be discontinued and washed out over the following 2 weeks. They will then begin Period B on the alternate blinded treatment with similar titration and assessment, initially weekly and then every other week for a total of another 8 weeks. The purpose of the study is to determine whether Iloperidone is effective in the treatment of some symptoms in patients with PTSD, particularly difficulty falling or staying asleep, trauma dreams and daytime irritability or outbursts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PTSD diagnosis
排除标准
- •Pregnancy
- •Traumatic Brain Injury greater than mild
- •Primary sleep disorder
- •Caffeinism
- •Active substance use disorder
- •Active suicidal risk
- •Antipsychotic medication, antibiotics, sedatives, some antihypertensive or antiarrhythmic medication
研究组 & 干预措施
Placebo / Iloperidone
During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.
干预措施: Placebo (Drug)
Iloperidone / Placebo
During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.
干预措施: Iloperidone (Drug)
Iloperidone / Placebo
During 1st treatment period subjects will receive iloperidone. During 2nd treatment period subjects will receive placebo.
干预措施: Placebo (Drug)
Placebo / Iloperidone
During 1st treatment period subjects will receive placebo. During 2nd treatment period subjects will receive Iloperidone.
干预措施: Iloperidone (Drug)
结局指标
主要结局
Change in Clinician Administered PTSD Scale (CAPS) Part B and D
时间窗: Randomization and at the end of each treatment period. Placebo treatment lasted 8 weeks. Iloperidone treatment lasted 2 weeks.
The Clinician-Administered PTSD Scale (CAPS) is a structured interview used to diagnose and assess PTSD. Part B of CAPS evaluates symptoms of re-experiencing. Part D evaluates avoidance and numbing. CAPS-B scores range from 0 to 40 where higher scores indicate more symptoms. A score 0 means no re-experiencing symptoms. CAPS-D scores range form 0 to 56 and higher scores indicate more symptoms. A score 0 means no avoidance or numbing symptoms. The primary endpoint was changes in CAPS part B and D after 8 weeks of treatment.
次要结局
- Sleep Latency(Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .)
- Wake-time After Sleep Onset (WASO)(Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .)
- Number of Awakenings(Randomization and after 1, 2, 4, 6 and 8 weeks of placebo treatment. Only 1 week of wrist actigraphy was recorded during iloperidone treatment .)
- Aggression(Randomization and 8 weeks of treatment, during both treatment periods)
- Intensity of Suicidal Ideation(Baseline)
- Suicidal Ideation(Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored)
- Suicidal Behavior(Total course of the study. CSSRS was administered during each study visit. Suicidal ideation during lifetime and during the month prior to screening were also explored)