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CompletedNCT03277339Insula-TOPUpdated Oct 12, 2022

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

A Phase 4 interventional study of Paroxetine and Thermal cure in Generalized Anxious Disorders, sponsored by Centre Hospitalier Henri Laborit. Completed at 2 sites in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-12.

Sponsored by Centre Hospitalier Henri Laborit · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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)
02

Conditions studied

  • Generalized Anxious Disorders

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Keywords

  • Generalized anxious disorders
  • Thermal cure
  • paroxetine
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
52 participants (actual)

Study arms

  • Experimental
    Paroxetine

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

    Drug: Paroxetine

  • Other
    Thermal cure

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

    Other: Thermal cure

Interventions

  • DrugParoxetine

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

  • OtherThermal cure

    Thermal cure is realized for 3 weeks

05

What researchers measure

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

06

Study locations

2 sites
  • Centre Hospitalier Henri Laborit
    Poitiers, France
  • Les thermes de Saujon
    Saujon, 17600, France
07

References and documents

Publications

  • 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. PubMed 21623668 ↗
  • 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. PubMed 22231312 ↗
  • 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. PubMed 21546788 ↗
  • 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. PubMed 21743468 ↗
  • 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. PubMed 20178872 ↗
08

Registry details

Key details

Study ID
NCT03277339
Lead 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
Responsible party
Sponsor
First posted
Sep 11, 2017
Start date
Jan 19, 2017
Primary completion
Jan 8, 2020
Completion
Feb 5, 2020
Last update
Oct 12, 2022

Study contacts

JAAFARI Nematollah, MD-PhD
principal investigator · Centre Hospitalier Henri Laborit
INGRAND Pierre, MD-PhD-PU-PH
study chair · Centre d'investigation clinique INSERM CIC P802

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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