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

Centre Hospitalier Henri Laborit

Status and phase

Completed

Phase 4

Conditions

Generalized Anxious Disorders

Treatments

Other: Thermal cure

Drug: Paroxetine

Study type

Interventional

Funder types

Other

Identifiers

NCT03277339

InsulaTOP

Details and patient eligibility

About

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

Full 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)

Enrollment

52 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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