Targeting Fear Memory by Disrupting the Process of Reconsolidating: A New Intervention for Panic Disorder
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 主要终点
- Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth addition (DSM-IV) Axis I Disorders
研究概览
简要总结
Animal and human fear conditioning studies have repeatedly shown that administering propranolol before or after retrieval of a previously acquired fear results in an elimination of the fear expression. This approach, known as disruption of fear memory reconsolidation, is a promising new avenue for treating anxiety disorders. The present study aims to test its efficacy in patients with panic disorder.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •a primary diagnosis of panic disorder according to DSM-V
- •written approval of an independent physician for participation
排除标准
- •other relevant treatment for panic disorder at the time of study - e.g., Cognitive Behavioral Therapy (CBT)
- •diagnosis of depression
- •diagnosis of psychosis
- •use of psychotropic medication
- •history of pulmonary diseases
- •metabolic acidosis
- •history of cardiovascular diseases
- •heart problems among first-degree relatives
- •heart rate (HR) < 60
- •blood pressure (BP) < 90-60 or BP > 170-100
- •history of black-outs or fainting
- •liver or kidney diseases
- •hyperactive production of thyroid hormones
- •any medication contra-indicative of the use of propranolol
- •pregnancy
研究组 & 干预措施
No fear reactivation with propranolol
干预措施: Compressed air (Other)
Fear reactivation with propranolol
干预措施: Propranolol (Drug)
Fear reactivation with propranolol
干预措施: Carbon dioxide (Other)
Fear reactivation with placebo
干预措施: Placebo (Drug)
Fear reactivation with placebo
干预措施: Carbon dioxide (Other)
No fear reactivation with propranolol
干预措施: Propranolol (Drug)
结局指标
主要结局
Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth addition (DSM-IV) Axis I Disorders
时间窗: Baseline and 3 months
Change in score on the Panic Disorder Severity Scale (PDSS-SR)
时间窗: Baseline, 7 days, 3 months
次要结局
- Carbon dioxide challenge using a visual analogue scale ranging from 0-100 mm(3 months)
- Change in score on the Panic Appraisal Inventory (PAI)(Baseline, 7 days, 3 months, 6 months, 1 year)
- Change in score on the Mobility Inventory (MI)(Baseline, 7 days, 3 months, 6 months, 1 year)
- Change in score on the Body Sensations Questionnaire (BSQ)(Baseline, 7 days, 3 months, 6 months, 1 year)
- Change in score on the Agoraphobic Cognitions Questionnaire (ACQ)(Baseline, 7 days, 3 months, 6 months, 1 year)
- Change in the number of participants diagnosed with panic disorder assessed by the Structured Clinical Interview for DSM-IV Axis I Disorders(Baseline, 6 months, 1 year)
- Change in score on the Panic Disorder Severity Scale (PDSS-SR)(Baseline, 6 months, 1 year)
研究者
Mrs. M. Kindt
Professor of Experimental and Clinical Psychology
VU University of Amsterdam