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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Henri Laborit
• Collaborators: Association Francaise pour la Recherche Thermale; Centre National de la Recherche Scientifique (CeRCA, umr 7295), France; Les thermes de Saujon; Poitiers University Hospital
• Treatments: Paroxetine

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