Investigating brain activity patterns in social anxiety disorder

Study of Slow Prefrontal Cortex Oscillations During Social Exposure in Social Anxiety Disorder

This study is testing how brain activity in people with social anxiety disorder reacts in social situations to see if it can help find new ways to treat their anxiety.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 20 Years to 50 Years
• Sex: All
• Sponsor: Institut National de la Santé Et de la Recherche Médicale, France (Government)
• Locations: 1 site (Bordeaux)
• Trial ID: NCT03821779 on ClinicalTrials.gov

What this trial studies

This study aims to explore the relationship between slow oscillations in the prefrontal cortex and pathological anxiety in individuals with social anxiety disorder. By utilizing in vivo social exposure, virtual reality settings, and EEG recordings, researchers will assess the neural mechanisms underlying anxiety responses. The study seeks to identify whether these brain activity patterns can serve as biomarkers for anxiety disorders, potentially leading to new treatment approaches. Participants will undergo psychometric evaluations and report their anxiety levels using a Visual Analogue Scale.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with social anxiety disorder as defined by the DSM-5.

Not a fit: Patients with severe medical or neurological co-morbidities, or those with other major psychiatric conditions, may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved diagnostic tools and treatment strategies for individuals suffering from social anxiety disorder.

How similar studies have performed: While the specific approach of using prefrontal oscillations as biomarkers in humans is novel, related studies in animal models have shown promising results in understanding anxiety mechanisms.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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:

  1. antidepressant treatments with selective serotonin recapture inhibitors, serotonin and norepinephrine inhibitors, alpha2-presynaptic adrenoreceptors (mirtazapine, mianserin), tricyclic
  2. anxiolytic drugs including benzodiazepines and anti-histamine
  3. 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)

Where this trial is running

Bordeaux

• GENPHASS, SANPSY, CHU de Bordeaux — Bordeaux, France (Recruiting)

Study contacts

• Principal investigator: Olivier Doumy, MD — Centre Hospitalier Charles Perrens, Bordeaux; INRA NutriNeuro, Bordeaux; Université de Bordeaux, France
• Study coordinator: Bruno Aouizerate, MD-PhD

Conditions Anxiety Disorders; Anxiety; Anxiety and Fear