A Randomized, Double Blind, Placebo-controlled Trial of Pregnenolone for Bipolar Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The 17-item Hamilton Rating Scale for Depression (HRSD17)
研究概览
简要总结
Primary purpose of this study is to determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms of patients with bipolar disorder. Also the study will explore possibilities of improving anxiety and manic symptoms as well as the patient's cognition.
详细描述
Determine if pregnenolone supplementation is associated with greater improvement in depressive symptoms than placebo in persons with Bipolar Depression (BPD), depressed phase. In our pilot study, pregnenolone showed a strong signal on depression scores.
Secondary
- Determine if pregnenolone supplementation is associated with greater improvement in anxiety symptoms in persons with BPD, depressed phase. Data from prior studies suggests that pregnenolone may decrease symptoms of anxiety. Anxiety is a common and clinically important feature of BPD. Therefore, we will examine anxiety symptoms in this trial.
- Determine if pregnenolone supplementation is associated with improvement in manic symptoms as compared to placebo in persons with BPD, depressed phase. Our pilot study suggested that pregnenolone may be associated with improvement in manic symptoms. Although the current study targets bipolar depression we will also examine manic symptoms.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Men and Women of all races age 18-75 years
- •Diagnosis of bipolar I, II or not otherwise specified (NOS) disorders currently meeting criteria for a major depressive episode
- •English speaking
排除标准
- •Active suicidal ideation with plan and intent
- •Treatment resistant depression
- •Vulnerable population (i.e. pregnant, cognitively impaired, incarcerated)
- •Severe or life threatening medical condition
- •History of allergic reaction or side effects with prior pregnenolone use
- •Current substance use disorder defined as meeting criteria for abuse or dependence based on the Structured Clinical Interview for the Diagnostic and Statistical Manual (DSM)(SCID) interview and self-reported use within the past 3 months or a positive baseline urine drug screen
- •Removal or addition of concomitant psychiatric medications within 10 days prior to randomization
- •Current Warfarin therapy
- •Current use of oral contraceptives
- •Current hormone replacement therapy
- •History of heart disease or arrhythmias
- •Current (past 7 days) systemic
研究组 & 干预措施
Pregnenolone
This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.
干预措施: Pregnenolone (Drug)
Placebo
The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
The 17-item Hamilton Rating Scale for Depression (HRSD17)
时间窗: 12 weeks
The HRSD is an observer-rated measure of depressive symptomatology. Minimum: 0; Maximum: 50; Better outcome: lower score; Normal score: 7 or less.
次要结局
- Inventory of Depressive Symptomatology-Self Report (IDS-SR)(12 weeks)
- Young Mania Rating Scale (YMRS)(12 weeks)
- Hamilton Rating Scale for Anxiety (HRSA)(12 weeks)
研究者
Sherwood Brown
Principal Investigator
University of Texas Southwestern Medical Center