Psycho-biological substrates of therapeutic benefit of thermal cure on Generalized Anxiety Disorders

Phase 1

Conditions: Generalised Anxiety Disorders
MedDRA version: 18.1Level: LLTClassification code 10018105Term: Generalized anxiety disorderSystem Organ Class: 100000004873
Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

Registration Number: EUCTR2015-003042-47-FR

Lead Sponsor: Centre Hospitalier Henri Laborit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

• Diagnostic of TAG according to 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 HAMA is greater or equal to 20
• Score of HAMA symptoms greater or equal to 8
• Score of HAMD 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 (Deroxat® ou Divarius®) 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