Insula-TOP: Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders
Study Details
Study Description
Brief Summary
Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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:
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A decrease of Insula activity at rest during the answers to aversive pictures and during the task of subjective measurement of heartbeat.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
Deroxat® (20 mg/day) 3 week; can be increase on week 2 until 50 mg.
|
| 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
Thermal cure is realized for 3 weeks
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
- 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]
- 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.]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnostic of generalized anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
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No treatment by antidepressant for at least 2 months
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No treatment by anxiolytic/neuroleptic/bete blockers/antipsychotic for at least 3 weeks
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Global score of Hamilton Anxiety Scale (HAM-A) is greater or equal to 20
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Score of HAM-A symptoms greater or equal to 8
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Score of Hamilton Depressive Scale (HAM-D) lower or equal to 7
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Age: Participants will be males and females, 18-75 years of age included.
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For women, no ongoing pregnancy/ negative pregnancy test
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No wounds
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Affiliation to a social security system (recipient or assignee)
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Signed written inform consent form
Exclusion Criteria:
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Treatment by antidepressant for at least 2 months or a treatment by anxiolytic, neuroleptic for at least 3 weeks
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Psychotropic treatment (antidepressant, anxiolytic and neuroleptic) between the preinclusion and inclusion
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Psychotherapy during the 3 months prior to the inclusion
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Thermal cure during the 6 months prior to the inclusion
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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
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Contraindication to paroxetine
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Enhanced protection (minors, pregnancies women, nursing women,people deprived of liberty by administrative or judicial decision, ...)
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Blood donation during the 3 months prior to the inclusion
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier Henri Laborit | Poitiers | France | ||
| 2 | Les thermes de Saujon | Saujon | France | 17600 |
Sponsors and Collaborators
- Centre Hospitalier Henri Laborit
- Association Francaise pour la Recherche Thermale
- Les thermes de Saujon
- Poitiers University Hospital
- Centre National de la Recherche Scientifique (CeRCA, umr 7295), France
Investigators
- Principal Investigator: JAAFARI Nematollah, MD-PhD, Centre Hospitalier Henri Laborit
- Study Chair: INGRAND Pierre, MD-PhD-PU-PH, Centre d'investigation clinique INSERM CIC P802
Study Documents (Full-Text)
None provided.More Information
Publications
- Dubois O, Salamon R, Germain C, Poirier MF, Vaugeois C, Banwarth B, Mouaffak F, Galinowski A, Olié 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.
- 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.
- 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.
- Jaafari N, Baup N, Bourdel MC, Olié 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.
- 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. Review.
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