Oxytocin substitution therapy in patients with AVP deficiency (central diabetes insipidus): a double-blind randomised placebo-controlled trial - the OxyTUTION trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.
研究概览
简要总结
Primary objective To determine the effect of internasal OXT (24 IU twice daily) compared to placebo for 28 (+/- 2) days on: ▪ Change in anxiety levels assessed with the State-Trait Anxiety Inventory (Trait-Anxiety Scale, STAI-T) ▪ Change in correct recognition of facial & body expressions assessed upon the EmBody/EmFace Task We hypothesize that the decrease in anxiety and/or increase in correct classification of facial & body expressions will be greater in the OXT group than in the placebo group.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients with a confirmed diagnosis of central diabetes insipidus based on accepted criteria
- •Heightened self-reported anxiety levels (STAI – Trait subscale ≥39 score points) or alexithymia levels (TAS-20 total ≥ 52 score points)
- •Stable hormone replacement therapy for at least three months with desmopressin and, in case of additional anterior pituitary deficiencies, with the respective substitution therapies
排除标准
- •Participation in a trial with investigational drugs within 30 days
- •Pregnancy and breastfeeding within the last 8 weeks
- •Active substance use disorder within the last six months
- •Consumption of alcoholic beverages >15 drinks/week
- •Unwilling to use a medically acceptable form of contraception throughout the study period (female of childbearing potential only)
- •Current or previous psychotic disorder (e.g., schizophrenia spectrum disorder)
- •Prolonged QTc-time > 470 ms assessed with a 12-lead electrocardiogram.
结局指标
主要结局
Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.
Trait anxiety level and correct classifications of facial & body expression after 28 (+/-2) days of treatment assessed with the STAI-T and the EmBody/EmFace Task. ▪ The STAI-T comprises 20 items scoring 1-4 points each. ▪ The EmBody/EmFace comprises 84 items scoring correct or incorrect each.
次要结局
- Emotion recognition and empathy
- Hormonal and subjective response to psychological stress
- Amygdala and subjective response in the functional MRI scan
- Further psychological outcomes
- Metabolic outcomes
- Objective assessment of a close third person
- Safety outcome
研究者
Cihan Atila
Scientific
Universitaetsspital Basel