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

Primary Purpose

Generalized Anxious Disorders

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

Paroxetine

Thermal cure

About this trial

This is an interventional treatment trial for Generalized Anxious Disorders focused on measuring Generalized anxious disorders, Thermal cure, paroxetine

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Centre Hospitalier Henri Laborit
Les thermes de Saujon

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Paroxetine

Thermal cure

Arm Description

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

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

Outcomes

Primary Outcome Measures

Decrease Insula activity during a resting state task

Secondary Outcome Measures

Changes of HAM-A score between day 1 and day 24.

Sensibility non conscientious to emotional interference in lexical task and in color identification task

Modulation of electrodermal response during presentation of predictive stimuli on aversive images and its links to the subjective view of emotional state

Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation

Lost of significant correlation (Day 24) between HAM-A score, introspective acuity and insula hyperactivation

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.

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.

Evaluation of efficacy of the thermal cure Day 56 using HAM-A score

Full Information

NCT ID

NCT03277339

First Posted

September 7, 2017

Last Updated

October 10, 2022

Sponsor

Centre Hospitalier Henri Laborit

Collaborators

Association Francaise pour la Recherche Thermale, Les thermes de Saujon, Poitiers University Hospital, Centre National de la Recherche Scientifique (CeRCA, umr 7295), France

1. Study Identification

Unique Protocol Identification Number

NCT03277339

Brief Title

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

Acronym

Insula-TOP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Completed

Study Start Date

January 19, 2017 (Actual)

Primary Completion Date

January 8, 2020 (Actual)

Study Completion Date

February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre Hospitalier Henri Laborit

Collaborators

Association Francaise pour la Recherche Thermale, Les thermes de Saujon, Poitiers University Hospital, Centre National de la Recherche Scientifique (CeRCA, umr 7295), France

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Generalized Anxious Disorders

Keywords

Generalized anxious disorders, Thermal cure, paroxetine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

52 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Paroxetine

Arm Type

Experimental

Arm Description

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

Arm Title

Thermal cure

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Paroxetine

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Thermal cure

Intervention Description

Thermal cure is realized for 3 weeks

Primary Outcome Measure Information:

Title

Decrease Insula activity during a resting state task

Time Frame

The evaluation of primary end point is performed between day 1 and day 24

Secondary Outcome Measure Information:

Title

Changes of HAM-A score between day 1 and day 24.

Time Frame

The evaluation of primary end point is performed between day 1 and day 24

Title

Sensibility non conscientious to emotional interference in lexical task and in color identification task

Time Frame

D= Day D1/D24/D56

Title

Modulation of electrodermal response during presentation of predictive stimuli on aversive images and its links to the subjective view of emotional state

Time Frame

D= Day D24

Title

Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation

Time Frame

D= Day D24

Title

Lost of significant correlation (Day 24) between HAM-A score, introspective acuity and insula hyperactivation

Time Frame

D= Day D24

Title

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.

Time Frame

D= Day D1/D24.

Title

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.

Time Frame

D= Day D1/D24.

Title

Evaluation of efficacy of the thermal cure Day 56 using HAM-A score

Time Frame

D= Day D56

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

JAAFARI Nematollah, MD-PhD

Organizational Affiliation

Centre Hospitalier Henri Laborit

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

INGRAND Pierre, MD-PhD-PU-PH

Organizational Affiliation

Centre d'investigation clinique INSERM CIC P802

Official's Role

Study Chair

Facility Information:

Facility Name

Centre Hospitalier Henri Laborit

City

Poitiers

Country

France

Facility Name

Les thermes de Saujon

City

Saujon

ZIP/Postal Code

17600

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

21623668

Citation

Jaafari N, Rachid F, Rotge JY, Polosan M, El-Hage W, Belin D, Vibert N, Pelissolo A. Safety and efficacy of repetitive transcranial magnetic stimulation in the treatment of obsessive-compulsive disorder: a review. World J Biol Psychiatry. 2012 Mar;13(3):164-77. doi: 10.3109/15622975.2011.575177. Epub 2011 May 30.

Results Reference

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PubMed Identifier

22231312

Citation

Jaafari N, Baup N, Bourdel MC, Olie JP, Rotge JY, Wassouf I, Sharov I, Millet B, Krebs MO. Neurological soft signs in OCD patients with early age at onset, versus patients with schizophrenia and healthy subjects. J Neuropsychiatry Clin Neurosci. 2011 Fall;23(4):409-16. doi: 10.1176/jnp.23.4.jnp409.

Results Reference

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PubMed Identifier

21546788

Citation

Jaafari N, Aouizerate B, Tignol J, El-Hage W, Wassouf I, Guehl D, Bioulac B, Daniel ML, Lacoste J, Gil R, Burbaud P, Rotge JY; Insight Study Group. The relationship between insight and uncertainty in obsessive-compulsive disorder. Psychopathology. 2011;44(4):272-6. doi: 10.1159/000323607. Epub 2011 May 6. Erratum In: Psychopathology. 2011;44(5):319.

Results Reference

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PubMed Identifier

21743468

Citation

Girard SL, Gauthier J, Noreau A, Xiong L, Zhou S, Jouan L, Dionne-Laporte A, Spiegelman D, Henrion E, Diallo O, Thibodeau P, Bachand I, Bao JY, Tong AH, Lin CH, Millet B, Jaafari N, Joober R, Dion PA, Lok S, Krebs MO, Rouleau GA. Increased exonic de novo mutation rate in individuals with schizophrenia. Nat Genet. 2011 Jul 10;43(9):860-3. doi: 10.1038/ng.886.

Results Reference

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PubMed Identifier

20178872

Citation

Dubois O, Salamon R, Germain C, Poirier MF, Vaugeois C, Banwarth B, Mouaffak F, Galinowski A, Olie JP. Balneotherapy versus paroxetine in the treatment of generalized anxiety disorder. Complement Ther Med. 2010 Feb;18(1):1-7. doi: 10.1016/j.ctim.2009.11.003. Epub 2010 Jan 6.

Results Reference

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

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