Prefrontal Oscillations in Social Anxiety Disorder (POSAD)

NCT03821779 | Active Not Recruiting DMC

• 1 other identifier: C17-25
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 biomarker of pathological anxiety in human subjects.

Conditions

Anxiety Disorders; Anxiety; Anxiety and Fear

Outcome Measures

Primary Outcomes (1)

• Change in power of slow oscillations in prefrontal EEG recordings during anticipation relative to baseline

  The change in power of PFC 2-6 Hz oscillations between the 5-minutes waiting period before oral presentation and the recovery period will be computed as a ratio. Detection of exaggerated 2-6Hz oscillations in prefrontal cortex during anxious anticipation is the primary aim of this study.

  During the 5 minutes before oral presentation and during the 1 hour rest period

Secondary Outcomes (1)

• Duration of prefrontal slow oscillations epochs during anticipation

  During the 5 minutes before oral presentation

Other Outcomes (26)

• Change in power of slow oscillations in prefrontal EEG recordings during presentation relative to baseline

  During the 5 minutes oral presentation and during the 1 hour rest period.

• Duration of prefrontal slow oscillations epochs during presentation

  During the 5 minutes oral presentation

• Correlation between prefrontal slow oscillations power during anticipation and anxiety score

  During the 5 minutes before oral presentation

Study Arms (3)

Group 1: Go-no-go phase

EXPERIMENTAL

The presence of significant prefrontal oscillations in the EEG recording 2-6Hz band during in vivo social exposure (oral presentation to examiners) will be assessed in 10 subjects with social anxiety disorder. EEG will be recorded immediately before, during and after oral presentations to examiners. Psychometric evaluation will be performed prior to experimental sessions. Rating of anxiety levels will be performed by subjects using a Visual Analogue Scale of anxiety during each of the 3 experimental periods (wainting, presentation, recovery). Results of EEG recordings in the first 10 subjects will lead to continuation (presence of significant slow prefrontal oscillations during anxiety) or interruption (absence of signification oscillation) of the study.

Behavioral: In vivo social exposure; Other: EEG recording; Diagnostic Test: Psychometric evaluation; Diagnostic Test: Visual Analogue Scale of anxiety

Group 2.1

EXPERIMENTAL

In group 2.1, 10 subjects will undergo 2 sessions in a cross-over design with EEG recording immediately before, during and after: 1. "real exposure": oral presentation to a panel of examiners 2. "virtual reality" : oral presentation to virtual examiners Rating of anxiety levels will be performed by subjects using a Visual Analogue Scale of anxiety during each of the 3 experimental periods for each session. Psychometric evaluation will be performed prior to experimental sessions.

Behavioral: In vivo social exposure; Behavioral: Social exposure in a virtual reality setting; Other: EEG recording; Diagnostic Test: Psychometric evaluation; Diagnostic Test: Visual Analogue Scale of anxiety

Group 2.2

EXPERIMENTAL

In group 2.2, 10 subjects will undergo 2 sessions in a cross-over design with EEG recording immediately before, during and after: 1. "virtual reality" : oral presentation to virtual examiners 2. "real exposure": oral presentation to a panel of examiners Rating of anxiety levels will be performed by subjects using a Visual Analogue Scale of anxiety during each of the 3 experimental periods for each session. Psychometric evaluation will be performed prior to experimental sessions.

Behavioral: In vivo social exposure; Behavioral: Social exposure in a virtual reality setting; Other: EEG recording; Diagnostic Test: Psychometric evaluation; Diagnostic Test: Visual Analogue Scale of anxiety

Interventions

Social exposure in a virtual reality setting BEHAVIORAL

Subjects will give a 5 minutes oral presentation on the subject of their choice to a virtual reality panel composed of 5 examiners displaying no facial emotional reaction, after a 5 minutes period of silent waiting in front of the examiners. This waiting period is expected to elicit anticipation-type of social anxiety.

Group 2.1; Group 2.2

In vivo social exposure BEHAVIORAL

Subjects will be invited to give a 5 minutes oral presentation on the topic of their choice to five examiners displaying no facial emotional reaction, after a 5 minutes period of silent waiting in front of the examiners. This waiting period is prompt to elicit anticipation-type of social anxiety.

Group 1: Go-no-go phase; Group 2.1; Group 2.2

EEG recording OTHER

EEG will be recorded with a standard 16-electrodes cap. Recordings will start before the 5 minutes waiting period and continue throughout oral presentation and recovery. The recovery period will be used as a baseline control

Group 1: Go-no-go phase; Group 2.1; Group 2.2

Psychometric evaluation DIAGNOSTIC_TEST

Subjects will be evaluated prior to inclusion using the following assessment tools * Anamnestic Association for Methodology and Documentation in Psychiatry (AMDP) questionnaire * Mini International Neuropsychiatric Interview (MINI 6.0, for psychiatric diagnoses) * Liebowitz Social Anxiety Scale (LSAS) * Montgomery Asberg Depression Rating Scale (MADRS) * Brief Anxiety Scale of Tyrer (BAS) * State-Trait Anxiety Inventory (STAI A-B) * Global Assessment of Functioning (GAF)

Group 1: Go-no-go phase; Group 2.1; Group 2.2

Visual Analogue Scale of anxiety DIAGNOSTIC_TEST

Subjects will be asked to rate their anxiety levels * immediately before (5 minutes of silent waiting), * during * and after the 5-minute oral presentation (recovery)

Group 1: Go-no-go phase; Group 2.1; Group 2.2

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Social anxiety disorder as defined in DSM-5
• Full understanding of the protocol
• Being registered in the french national health insurance service (Sécurité Sociale) (or equivalent)

You may not qualify if:

• 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
• Pregnancy or breastfeeding.
• Ongoing hospitalization without consent (decision of a third-party: medical, justice)

Sponsors & Collaborators

• Institut National de la Santé Et de la Recherche Médicale, France: lead

Study Sites (1)

GENPHASS, SANPSY, CHU de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Olivier Doumy, MD

  Centre Hospitalier Charles Perrens, Bordeaux; INRA NutriNeuro, Bordeaux; Université de Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Alexandra Bouvard, MD

  Centre Hospitalier Charles Perrens, Bordeaux; Université de Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Cyril Herry, PhD

  Neurocentre Magendie, Inserm U1215, Bordeaux, France

  STUDY DIRECTOR

• Cyril Dejean, PhD

  Neurocentre Magendie, Inserm U1215, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Thomas Bienvenu, PhD

  Centre Hospitalier Charles Perrens, Bordeaux; Neurocentre Magendie, Inserm U1215, Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Jacques Taillard, MS

  GENPHASS, CHU de Bordeaux

  PRINCIPAL INVESTIGATOR

• Bruno Aouizerate, MD-PhD

  Centre Hospitalier Charles Perrens, Bordeaux; INRA NutriNeuro, Bordeaux; Université de Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: First phase (go-no-go) with 10 subjects in 1 arm Second phase with 20 subjets (2 arms) in a cross-over design.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: January 30, 2019
• Study Start: November 12, 2019
• Primary Completion: November 8, 2025
• Study Completion (Estimated): May 9, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)