Adjunctive Pregnenolone in PTSD and Depression in OEF/OIF Veterans
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Clinician Administered PTSD Scale (CAPS)
研究概览
简要总结
This study will be an 8-week randomized, placebo-controlled clinical trial of pregnenolone administered adjunctively to treatment as usual in PTSD and depression in OEF/OIF Veterans.
详细描述
PTSD and depression are critical areas of immediate impact to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF) Veterans. Current treatments for PTSD (which frequently co-occurs with depression) remain limited, with many patients remaining symptomatic despite single or combination administration of SSRIs, mood stabilizers, antipsychotics and sedatives/hypnotics. In addition, many patients treated for depression remain symptomatic. New interventions are thus urgently needed in PTSD with co-occurring depression to ensure optimal functional outcomes for our Service members and their families.
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
- Double
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
- •Diagnosis of PTSD,
- •diagnosis of MDD,
- •age 18-55,
- •no change in psychotropic medication for >=4 weeks,
- •no anticipated need to to alter psychotropic medication for duration of study
排除标准
- •Unstable medical/neurological illness,
- •diagnosis of bipolar disorder, schizophrenia or other psychotic disorder,
- •cognitive disorder,
- •substance dependence,
- •positive urine drug screen at screening,
- •use of hormonal supplementation,
- •pregnancy/lactation,
- •female patients who are sexually active and not using acceptable non-hormonal birth control,
- •initiation/change of psychotherapy within 3 months of randomization,
- •recent/current electroconvulsive therapy,
- •regular use of opiates/barbiturates/benzodiazepines
研究组 & 干预措施
Arm 1
adjunctive pregnenolone
干预措施: pregnenolone (Drug)
Arm 2
adjunctive placebo
干预措施: placebo (Drug)
结局指标
主要结局
Clinician Administered PTSD Scale (CAPS)
时间窗: 8 weeks
次要结局
未报告次要终点