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Generalized Anxious DisordersPhase 4Insula-TOPNCT03277339

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

A Phase 4 study testing Paroxetine and Thermal cure in people with Generalized Anxious Disorders, run by Centre Hospitalier Henri Laborit at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Generalized Anxious Disorders
What is being tested?
Paroxetine and Thermal cure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesFrance
Study dates
19 Jan 2017to 5 Feb 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Centre Hospitalier Henri Laborit

    Poitiers

  • Les thermes de Saujon

    Saujon, 17600

Other trials in France

About this study

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

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

Read the 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)
Being tested
Paroxetine, Thermal cure
Keywords
Generalized anxious disorders, Thermal cure, paroxetine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ParoxetineDrug

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

  • Thermal cureOther

    Thermal cure is realized for 3 weeks

Study groups in NCT03277339
Study groupRoleWhat they receive
ParoxetineExperimentalParoxetine (Deroxat®) Posology : 20 mg per day for 3 weeks. After 2 weeks of treatments, if indicated, physicians will prescribe until 50 mg.
Receives: Drug: Paroxetine
Thermal cureOtherThis study is controlled with a comparator which is the Thermal cure. Thermal cure is realized for 3 weeks.
Receives: Other: Thermal cure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Decrease Insula activity during a resting state task

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

Secondary outcomes (8)

  1. Changes of HAM-A score between day 1 and day 24.

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

  2. Sensibility non conscientious to emotional interference in lexical task and in color identification task

    Measured: D= Day D1/D24/D56

  3. Modulation of electrodermal response during presentation of predictive stimuli on aversive images and its links to the subjective view of emotional state

    Measured: D= Day D24

  4. Modulation of electrodermal response during presentation of predictive stimuli on aversive images and insula activation

    Measured: D= Day D24

  5. Lost of significant correlation (Day 24) between HAM-A score, introspective acuity and insula hyperactivation

    Measured: D= Day D24

  6. 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.

    Measured: D= Day D1/D24.

  7. 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.

    Measured: D= Day D1/D24.

  8. Evaluation of efficacy of the thermal cure Day 56 using HAM-A score

    Measured: D= Day D56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Sep 2017
  2. Study start19 Jan 2017
  3. Primary completion8 Jan 2020
  4. Study completion5 Feb 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03277339
Sponsor's protocol ID
InsulaTOP
Acronym
Insula-TOP
Status last verified
Oct 2022
First submitted
7 Sep 2017
Last updated
12 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 21623668

  • 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.

    PubMed 22231312

  • 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.

    PubMed 21546788

  • 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.

    PubMed 21743468

  • 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.

    PubMed 20178872

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paroxetine and Thermal cure in people with Generalized Anxious Disorders, run by Centre Hospitalier Henri Laborit at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Decrease Insula activity during a resting state task (time frame: The evaluation of primary end point is performed between day 1 and day 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03277339, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2022.

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