Trial | NCT03277339  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    Paroxetine ...

  • Study Participants

    52
Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders
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)
Study Started
Jan 19
2017
Primary Completion
Jan 08
2020
Study Completion
Feb 05
2020
Last Update
Oct 12
2022

Drug Paroxetine

Deroxat® (20 mg/day) 3 week; can be increase on week 2 until 50 mg.

Other Thermal cure

Thermal cure is realized for 3 weeks

Paroxetine Experimental

Paroxetine (Deroxat®) Posology : 20 mg per day for 3 weeks. After 2 weeks of treatments, if indicated, physicians will prescribe until 50 mg.

Thermal cure Other

This study is controlled with a comparator which is the Thermal cure. Thermal cure is realized for 3 weeks.

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
No Results Posted