Status:
COMPLETED
Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders
Lead Sponsor:
Centre Hospitalier Henri Laborit
Collaborating Sponsors:
Association Francaise pour la Recherche Thermale
Les thermes de Saujon
Conditions:
Generalized Anxious Disorders
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
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 therm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 5 2020
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT03277339
Start Date
January 19 2017
End Date
February 5 2020
Last Update
October 12 2022
Active Locations (2)
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1
Centre Hospitalier Henri Laborit
Poitiers, France
2
Les thermes de Saujon
Saujon, France, 17600