Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders

Study Overview
=================
Brief Summary
-----------------
Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders

Detailed Description
-----------------
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)

Official Title
-----------------
Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders (Insula-TOP)

Conditions
-----------------
Generalized Anxious Disorders

Intervention / Treatment
-----------------
* Drug: Paroxetine
* Other: Thermal cure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paroxetine<br>Paroxetine (Deroxat®) Posology : 20 mg per day for 3 weeks. After 2 weeks of treatments, if indicated, physicians will prescribe until 50 mg. | Drug: Paroxetine<br>* Deroxat® (20 mg/day) 3 week; can be increase on week 2 until 50 mg.<br>|
| Other: Thermal cure<br>This study is controlled with a comparator which is the Thermal cure. Thermal cure is realized for 3 weeks. | Other: Thermal cure<br>* Thermal cure is realized for 3 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease Insula activity during a resting state task |  | The evaluation of primary end point is performed between day 1 and day 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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. | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Generalized anxious disorders, Thermal cure, paroxetine