Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Association Francaise pour la Recherche Thermale | OTHER |
| Les thermes de Saujon | UNKNOWN |
| Poitiers University Hospital | OTHER |
| Centre National de la Recherche Scientifique (CeRCA, umr 7295), France |
Not provided
Not provided
Not provided
Not provided
Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paroxetine | Experimental | Paroxetine (Deroxat®) Posology : 20 mg per day for 3 weeks. After 2 weeks of treatments, if indicated, physicians will prescribe until 50 mg. |
|
| Thermal cure | Other | This study is controlled with a comparator which is the Thermal cure. Thermal cure is realized for 3 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paroxetine | Drug | Deroxat® (20 mg/day) 3 week; can be increase on week 2 until 50 mg. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease Insula activity during a resting state task | The evaluation of primary end point is performed between day 1 and day 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| JAAFARI Nematollah, MD-PhD | Centre Hospitalier Henri Laborit | Principal Investigator |
| INGRAND Pierre, MD-PhD-PU-PH | Centre d'investigation clinique INSERM CIC P802 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Henri Laborit | Poitiers | France | ||||
| Les thermes de Saujon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21623668 | Background | 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. | |
| 22231312 | Background |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
| Thermal cure |
| Other |
Thermal cure is realized for 3 weeks |
|
| 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 |
| Saujon |
| 17600 |
| France |
| 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. |
| 21546788 | Background | 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. |
| 21743468 | Background | 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. |
| 20178872 | Background | 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. |