Generalized Anxious Disorders Clinical Trial
— Insula-TOPOfficial title:
Psycho-biological Substrates of Therapeutic Benefit of Thermal Cure on Generalized Anxiety Disorders (Insula-TOP)
| Verified date | October 2022 |
| Source | Centre Hospitalier Henri Laborit |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Multicenter study comparing paroxetine (n=30) versus thermal cure (n=30) in patients with a diagnosis of Generalised Anxiety Disorders
| Status | Completed |
| Enrollment | 52 |
| Est. completion date | February 5, 2020 |
| Est. primary completion date | January 8, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility | 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: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Hospitalier Henri Laborit | Poitiers | |
| France | Les thermes de Saujon | Saujon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Henri Laborit | Association Francaise pour la Recherche Thermale, Centre National de la Recherche Scientifique (CeRCA, umr 7295), France, Les thermes de Saujon, Poitiers University Hospital |
France,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Decrease Insula activity during a resting state task | The evaluation of primary end point is performed between day 1 and day 24 | ||
| Secondary | 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 | ||
| Secondary | Sensibility non conscientious to emotional interference in lexical task and in color identification task | D= Day D1/D24/D56 | ||
| Secondary | 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 | ||
| Secondary | Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation | D= Day D24 | ||
| Secondary | Lost of significant correlation (Day 24) between HAM-A score, introspective acuity and insula hyperactivation | D= Day D24 | ||
| Secondary | 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. | ||
| Secondary | 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. | ||
| Secondary | Evaluation of efficacy of the thermal cure Day 56 using HAM-A score | D= Day D56 |