Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Deroxat® (20 mg/day) 3 week; can be increase on week 2 until 50 mg.
Thermal cure is realized for 3 weeks
Centre Hospitalier Henri Laborit
Poitiers, France
Les thermes de Saujon
Saujon, France
Decrease Insula activity during a resting state task
Time frame: The evaluation of primary end point is performed between day 1 and day 24
Changes of HAM-A score between day 1 and day 24.
Time frame: 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
Time frame: D= Day D1/D24/D56
Modulation of electrodermal response during presentation of predictive stimuli on aversive images and its links to the subjective view of emotional state
Time frame: D= Day D24
Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation
Time frame: D= Day D24
Lost of significant correlation (Day 24) between HAM-A score, introspective acuity and insula hyperactivation
Time frame: D= Day D24
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.
Time frame: D= Day D1/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.
Time frame: D= Day D1/D24.
Evaluation of efficacy of the thermal cure Day 56 using HAM-A score
Time frame: D= Day D56
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