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

NCT03277339 | Completed Phase 4

• 1 other identifier: InsulaTOP
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Generalized Anxious Disorders

Keywords

Generalized anxious disorders; Thermal cure; paroxetine

Outcome Measures

Primary Outcomes (1)

• Decrease Insula activity during a resting state task

  The evaluation of primary end point is performed between day 1 and day 24

Secondary Outcomes (8)

• 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

Study Arms (2)

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.

Drug: Paroxetine

Thermal cure

OTHER

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

Other: Thermal cure

Interventions

Paroxetine DRUG

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

Paroxetine

Thermal cure OTHER

Thermal cure is realized for 3 weeks

Thermal cure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Treatment by antidepressant for at least 2 months or a treatment by anxiolytic, neuroleptic for at least 3 weeks
• Contraindication to paroxetine
• Enhanced protection (minors, pregnancies women, nursing women,people deprived of liberty by administrative or judicial decision, ...)

Sponsors & Collaborators

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

Study Sites (2)

Centre Hospitalier Henri Laborit

Poitiers, France

Location

Les thermes de Saujon

Saujon, 17600, France

Location

Related Publications (5)

• 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.

  PMID: 21623668 BACKGROUND

• 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.

  PMID: 22231312 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.

  PMID: 21546788 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.

  PMID: 21743468 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.

  PMID: 20178872 BACKGROUND

MeSH Terms

Interventions

Paroxetine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 11, 2017
• Study Start: January 19, 2017
• Primary Completion: January 8, 2020
• Study Completion: February 5, 2020
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

FR (2)