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

Phase 4

Completed

• Conditions: Generalized Anxious Disorders
• Interventions: Other: Thermal cure; Drug: Paroxetine

• Registration Number: NCT03277339
• Lead Sponsor: Centre Hospitalier Henri Laborit

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 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 Timeline

• Study Start: 2017-01-19
• Study First Submitted: 2017-09-07
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-11
• Primary Completion: 2020-01-08
• Study Completion: 2020-02-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-10
• Last Update Posted: 2022-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermal cure	Thermal cure	This study is controlled with a comparator which is the Thermal cure. Thermal cure is realized for 3 weeks.
Paroxetine	Paroxetine	Paroxetine (Deroxat®) Posology : 20 mg per day for 3 weeks. After 2 weeks of treatments, if indicated, physicians will prescribe until 50 mg.

Primary Outcome Measures

Name	Time	Method
Decrease Insula activity during a resting state task	The evaluation of primary end point is performed between day 1 and day 24

Secondary Outcome Measures

Name	Time	Method
Changes of HAM-A score between day 1 and day 24.	The evaluation of primary end point is performed between day 1 and day 24
Sensibility non conscientious to emotional interference in lexical task and in color identification task	D= Day D1/D24/D56
Evolution (Day 1 and Day 24) of the correlation between HAM-A global score and 1- the measure of heartbeat 2- emotional reactivity during aversive images task.	D= Day D1/D24.
Modulation of electrodermal response during presentation of predictive stimuli on aversive images and its links to the subjective view of emotional state	D= Day D24
Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation	D= Day D24
Lost of significant correlation (Day 24) between HAM-A score, introspective acuity and insula hyperactivation	D= Day D24
Difference (Day 1 and Day 24) of correlations between the symptoms severity and the activation of insula cortex during 1-aversive images task, 2-heartbeat measure task.	D= Day D1/D24.
Evaluation of efficacy of the thermal cure Day 56 using HAM-A score	D= Day D56

Trial Locations

Locations (2)

Centre Hospitalier Henri Laborit; 🇫🇷 Poitiers, France

Les thermes de Saujon; 🇫🇷 Saujon, France