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Completed

NCT Number: NCT03277339

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

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

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Centre Hospitalier Henri Laborit, Poitiers, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paroxetine

Drug

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

thermal cure

Other

Thermal cure is realized for 3 weeks

Primary outcomes

  1. 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 outcomes

  1. 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

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

    Time frame: D= Day D1/D24/D56

  3. 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

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

    Time frame: D= Day D24

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

    Time frame: D= Day D24

  6. 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.

  7. 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.

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

    Time frame: D= Day D56

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Insula-TOP

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2017
Registry last updated
Oct 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.