NCT03277339已完成4 期
Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders (Insula-TOP)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Decrease Insula activity during a resting state task
研究概览
简要总结
Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders
详细描述
Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders
Main objective is to quantify the therapeutic benefit of a thermal cure on generalized anxiety disorders and to understand the psycho-biological substrates of this improvement.
Secondary objectives:
- A decrease of Insula activity at rest during the answers to aversive pictures and during the task of subjective measurement of heartbeat.
- A decrease of sensibility to emotional interference by subliminal presentation of emotional words thanks to a lexical task and a color recognition task associated to simultaneous measurement of physiological indicator of emotional activity ( dermal resistance)
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
- None
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
- •Diagnostic of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- •No treatment by antidepressant for at least 2 months
- •No treatment by anxiolytic/neuroleptic/bete blockers/antipsychotic for at least 3 weeks
- •Global score of Hamilton Anxiety Scale (HAM-A) is greater or equal to 20
- •Score of HAM-A symptoms greater or equal to 8
- •Score of Hamilton Depressive Scale (HAM-D) lower or equal to 7
- •Age: Participants will be males and females, 18-75 years of age included.
- •For women, no ongoing pregnancy/ negative pregnancy test
- •No wounds
- •Affiliation to a social security system (recipient or assignee)
- •Signed written inform consent form
排除标准
- •Treatment by antidepressant for at least 2 months or a treatment by anxiolytic, neuroleptic for at least 3 weeks
- •Psychotropic treatment (antidepressant, anxiolytic and neuroleptic) between the preinclusion and inclusion
- •Psychotherapy during the 3 months prior to the inclusion
- •Thermal cure during the 6 months prior to the inclusion
- •Treatment by paroxetine for at least 1 month with dose equal or superior to 20 mg per day during the 12 months prior to the inclusion
- •Contraindication to paroxetine
- •Enhanced protection (minors, pregnancies women, nursing women,people deprived of liberty by administrative or judicial decision, ...)
- •Blood donation during the 3 months prior to the inclusion
研究组 & 干预措施
Paroxetine
Experimental
Paroxetine (Deroxat®) Posology : 20 mg per day for 3 weeks. After 2 weeks of treatments, if indicated, physicians will prescribe until 50 mg.
干预措施: Paroxetine (Drug)
Thermal cure
Other
This study is controlled with a comparator which is the Thermal cure. Thermal cure is realized for 3 weeks.
干预措施: Thermal cure (Other)
结局指标
主要结局
Decrease Insula activity during a resting state task
时间窗: The evaluation of primary end point is performed between day 1 and day 24
次要结局
- Changes of HAM-A score between day 1 and day 24.(The evaluation of primary end point is performed between day 1 and day 24)
- Sensibility non conscientious to emotional interference in lexical task and in color identification task(D= Day D1/D24/D56)
- Evolution (Day 1 and Day 24) of the correlation between HAM-A global score and 1- the measure of heartbeat 2- emotional reactivity during aversive images task.(D= Day D1/D24.)
- Modulation of electrodermal response during presentation of predictive stimuli on aversive images and its links to the subjective view of emotional state(D= Day D24)
- Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation(D= Day D24)
- Lost of significant correlation (Day 24) between HAM-A score, introspective acuity and insula hyperactivation(D= Day D24)
- Difference (Day 1 and Day 24) of correlations between the symptoms severity and the activation of insula cortex during 1-aversive images task, 2-heartbeat measure task.(D= Day D1/D24.)
- Evaluation of efficacy of the thermal cure Day 56 using HAM-A score(D= Day D56)
研究者
研究点 (2)
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