NCT03277339

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Centre Hospitalier Henri Laborit · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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)

Conditions

• Generalized Anxious Disorders

Interventions

Type	Name	Description
DRUG	Paroxetine	Deroxat® (20 mg/day) 3 week; can be increase on week 2 until 50 mg.
OTHER	Thermal cure	Thermal cure is realized for 3 weeks

Timeline

• Start date: 2017-01-19
• Primary completion: 2020-01-08
• Completion: 2020-02-05
• First posted: 2017-09-11
• Last updated: 2022-10-12

Locations

2 sites across 1 country: France