Influence of Pregnenolone on Distress and Autonomic Parameters During Cognitive-behavioral Exposure Therapy in Patients With Obsessive-compulsive Disorder
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Subjective units of distress (SUD)
研究概览
简要总结
Characterization of the influence of pregnenolone vs. placebo on subjective distress and autonomic functioning during cognitive-behavioral exposure therapy in patients with obsessive-compulsive disorder.
详细描述
Main out-come parameters:
Inter-session habituation as per SUD (100 mm VAS), Y-BOCS
Secondary out-come parameter:
HF/LF of HRV, Salivary epinephrine
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OCD according to DSM-IV criteria.
排除标准
- •Acute suicidality
- •psychotic disorders,
- •bipolar disorder
- •substance dependency
- •organic brain disorder
- •pregnancy
- •lactation
- •tuberculosis
- •gastric/duodenal ulcer
- •diabetes mellitus
- •acute inflammation
- •autoimmune disorders
- •arterial hypertension
- •therapy with glucocorticoids (up to 4 weeks ago)
研究组 & 干预措施
Nutritional supplement Pregnenolone
Exposure therapy, exposure with response prevention and pharmacological facilitation (nutritional supplement pregnenolone), orally two hours before exposure therapy.
干预措施: Exposure therapy with pharmacological facilitation (Behavioral)
Placebo
Exposure therapy, exposure with response prevention without pharmacological facilitation (Placebo), orally two hours before exposure therapy.
干预措施: Exposure therapy (Behavioral)
结局指标
主要结局
Subjective units of distress (SUD)
时间窗: During exposure therapy
次要结局
- Low/high frequency index of heart rate variability (L/HFI)(During exposure therapy)