Status:
RECRUITING
Prefrontal Oscillations in Social Anxiety Disorder (POSAD)
Lead Sponsor:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Anxiety Disorders
Anxiety
Eligibility:
All Genders
20-50 years
Phase:
NA
Brief Summary
Experimental fear in rodents is correlated with slow oscillations in electrical recordings of prefrontal cortex activities. The present study aims to test whether slow prefrontal oscillations is a bio...
Detailed Description
Fear and anxiety are adaptive responses that may become excessive or inappropriate in pathological conditions, as defined as anxiety disorders in DSM-5. These disorders, including phobic disorders suc...
Eligibility Criteria
Inclusion
- Social anxiety disorder as defined in DSM-5
- Full understanding of the protocol
- Obtaining informed consent from study subjects before or at inclusion at the latest
- Being registered in the french national health insurance service (Sécurité Sociale) (or equivalent)
Exclusion
- Active medical co-morbidity including severe hypertension, cardiac insufficiency, Raynaud syndrome, diabetes mellitus, renal insufficiency, adrenal insufficiency, Cushing syndrome and epilepsy
- Severe neurological co-morbidity, including but not limited to Parkinson's disease and multiple sclerosis
- Long-term corticotherapy
- History of significant head injury, defined by loss of consciousness
- Being diagnosed with another major psychiatric condition (DSM5) including bipolar disorder and schizophrenia or substance/alcohol use disorder; with the exception of major depressive disorder and nicotine use disorder
- Suicidal risk evaluated as moderate to high in the MINI questionnaire
- initiation of a psychotropic treatment or change in the dose of ongoing psychotropic treatment within 3 days prior to each visit and including:
- antidepressant treatments with selective serotonin recapture inhibitors, serotonin and norepinephrine inhibitors, alpha2-presynaptic adrenoreceptors (mirtazapine, mianserin), tricyclic
- anxiolytic drugs including benzodiazepines and anti-histamine
- antipsychotic drugs
- Acute alcohol intake 2 days prior to each visit (inclusion, experimental sessions)
- Pregnancy or breastfeeding.
- Ongoing hospitalization without consent (decision of a third-party: medical, justice)
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 9 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03821779
Start Date
November 12 2019
End Date
May 9 2026
Last Update
January 23 2025
Active Locations (1)
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1
GENPHASS, SANPSY, CHU de Bordeaux
Bordeaux, France, 33076