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

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003042-47-FR

Enrollment

Unknown

Registered

2016-02-26

Start date

2015-12-16

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalised Anxiety Disorders MedDRA version: 18.1 Level: LLT Classification code 10018105 Term: Generalized anxiety disorder System Organ Class: 100000004873

Interventions

Trade Name: Deroxat® Pharmaceutical Form: Buccal tablet

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 Objective: • A decrease of Insula activity at rest during the answers to aversives 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 recogniton task associated to simultaneous measurement of pysiological indicator of emotional activity ( dermal resistance);Primary end point(s): Changes of HAM-A score between day 1 and day 24. This modification should be associated to a decrease of insula activation during aversive images task and a decrease of the relation between insula activation and somatosensorial insight measured by heartbeat perception task. ;Timepoint(s) of evaluation of this end point: The evaluation of primary end point is performed between day 1 and day 24	—

Measure

Time frame

Main Objective: 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 Objective: • A decrease of Insula activity at rest during the answers to aversives 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 recogniton task associated to simultaneous measurement of pysiological indicator of emotional activity ( dermal resistance);Primary end point(s): Changes of HAM-A score between day 1 and day 24. This modification should be associated to a decrease of insula activation during aversive images task and a decrease of the relation between insula activation and somatosensorial insight measured by heartbeat perception task. ;Timepoint(s) of evaluation of this end point: The evaluation of primary end point is performed between day 1 and day 24

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 1- D1/D24/D56 2-D24 3-D24 4-D24 5-D1/D24. 6-D1/D24. 7-D56;Secondary end point(s): • 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 (Day 24) • Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation (Day 24) • 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	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 1- D1/D24/D56 2-D24 3-D24 4-D24 5-D1/D24. 6-D1/D24. 7-D56;Secondary end point(s): • 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 (Day 24) • Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation (Day 24) • 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

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Countries

France

Contacts

Public ContactNicolas Langbour

Centre Hospitalier Henri Laborit

nicolas.langbour@ch-poitiers.fr00335 16 52 61 18

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026