Anxiety DisordersPOSADNCT03821779
Prefrontal Oscillations in Social Anxiety Disorder (POSAD)
A study testing In vivo social exposure, Social exposure in a virtual reality setting and EEG recording in people with Anxiety Disorders and Anxiety, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Anxiety Disorders, Anxiety, Anxiety and Fear
- What is being tested?
- In vivo social exposure, Social exposure in a virtual reality setting and EEG recording
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 12 Nov 2019to 9 May 2026
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Slow Prefrontal Cortex Oscillations During Social Exposure in Social Anxiety Disorder
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.
Read the 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 such as social anxiety disorder, are frequent and impairing in the general population, with an estimated lifetime prevalence of 28% and significant consequences on quality of life. Direct and indirect medical costs related to these conditions amount to 74.4 billion €/year in Europe. Despite their prevalence, debilitating nature and chronicity, the pathophysiology of anxiety disorders is poorly understood and neurobiological treatments, including pharmacotherapy, are lacking efficacy. A better understanding of the neuronal mechanisms implicated in anxiety is necessary for the conception of new approaches to treat pathological anxiety.
Anxiety is commonly modeled in animals using fear conditioning, which consists in associating a neutral stimulus (eg: a sound) with a mild electrical foot-shock. As a result of the association between sound and shock, sound presentation in isolation induces a set of conditioned behavioral responses, such as an immobilization ("freezing"). Previous studies have shown that the expression of fear responses, measured on the basis of freezing, is associated with the emergence of slow oscillations (2-6Hz) in medial prefrontal cortex (mPFC) of mice. Moreover, emergence of these oscillations in mPFC is predictive of the occurrence of freezing, and the artificial induction of 4 Hz oscillations in mPFC with optogenetics induces freezing. Finally, inhibiting neurons in mPFC during the ascending phase of this slow mPFC oscillation at the time of conditioned sound presentation is sufficient to significantly reduce fear.
Interestingly, these results obtained in mice seem to find their prolongation in humans. Recent studies using fear conditioning in human subjects have also reported the emergence of prefrontal slow oscillations between 2-6 Hz during expression of conditioned fear responses. These results suggests that common mechanisms underlie the expression of fear in humans and rodents. However, whether similar neuronal circuits and mechanisms are implicated in human anxiety disorders remains unknown.
This study aims at assessing the presence of slow mPFC oscillations during expression of anxiety in patients suffering from anxiety disorders. Beyond understanding of the neuronal mechanisms underlying anxiety expression, this study could provide a biomarker of anxiety with diagnostic and therapeutic implications.
- Conditions
- Anxiety Disorders, Anxiety, Anxiety and Fear
- Being tested
- In vivo social exposure, Social exposure in a virtual reality setting, EEG recording, Psychometric evaluation, Visual Analogue Scale of anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In vivo social exposureBehavioural
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.
Social exposure in a virtual reality settingBehavioural
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.
EEG recordingOther
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
Psychometric evaluationDiagnostic 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)
Visual Analogue Scale of anxietyDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Time-frequency analysis will be performed to determine the duration of 2-6Hz prefrontal oscillations epochs and total duration of these oscillations within experimental period. Significant oscillatory epochs will be defined using power ratios. These metrics will be used in order to assess the neurobiological and clinical relevance of this biomarker.
Measured: During the 5 minutes before oral presentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2019
- Study start12 Nov 2019
- Primary completion8 Nov 2025
- Study completion9 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- First phase (go-no-go) with 10 subjects in 1 arm Second phase with 20 subjets (2 arms) in a cross-over design.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Olivier Doumy, MD, Principal investigator, Centre Hospitalier Charles Perrens, Bordeaux; INRA NutriNeuro, Bordeaux; Université de Bordeaux, FranceAlexandra Bouvard, MD, Principal investigator, Centre Hospitalier Charles Perrens, Bordeaux; Université de Bordeaux, FranceCyril Herry, PhD, Study director, Neurocentre Magendie, Inserm U1215, Bordeaux, FranceCyril Dejean, PhD, Principal investigator, Neurocentre Magendie, Inserm U1215, Bordeaux, FranceThomas Bienvenu, PhD, Principal investigator, Centre Hospitalier Charles Perrens, Bordeaux; Neurocentre Magendie, Inserm U1215, Bordeaux, FranceJacques Taillard, MS, Principal investigator, GENPHASS, CHU de BordeauxBruno Aouizerate, MD-PhD, Study chair, Centre Hospitalier Charles Perrens, Bordeaux; INRA NutriNeuro, Bordeaux; Université de Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03821779
- Sponsor's protocol ID
- C17-25
- Acronym
- POSAD
- Status last verified
- Feb 2026
- First submitted
- 29 Nov 2018
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Slow Prefrontal Cortex Oscillations During Social Exposure in Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT03821779
- Acronym / sponsor ID
- POSAD / C17-25
- Conditions
- Anxiety Disorders, Anxiety, Anxiety and Fear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 8 Nov 2025 (actual)
- Study completion
- 9 May 2026 (actual)
- First posted
- 30 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 such as social anxiety disorder, are frequent and impairing in the general population, with an estimated lifetime prevalence of 28% and significant consequences on quality of life. Direct and indirect medical costs related to these conditions amount to 74.4 billion €/year in Europe. Despite their prevalence, debilitating nature and chronicity, the pathophysiology of anxiety disorders is poorly understood and neurobiological treatments, including pharmacotherapy, are lacking efficacy. A better understanding of the neuronal mechanisms implicated in anxiety is necessary for the conception of new approaches to treat pathological anxiety.
Anxiety is commonly modeled in animals using fear conditioning, which consists in associating a neutral stimulus (eg: a sound) with a mild electrical foot-shock. As a result of the association between sound and shock, sound presentation in isolation induces a set of conditioned behavioral responses, such as an immobilization ("freezing"). Previous studies have shown that the expression of fear responses, measured on the basis of freezing, is associated with the emergence of slow oscillations (2-6Hz) in medial prefrontal cortex (mPFC) of mice. Moreover, emergence of these oscillations in mPFC is predictive of the occurrence of freezing, and the artificial induction of 4 Hz oscillations in mPFC with optogenetics induces freezing. Finally, inhibiting neurons in mPFC during the ascending phase of this slow mPFC oscillation at the time of conditioned sound presentation is sufficient to significantly reduce fear.
Interestingly, these results obtained in mice seem to find their prolongation in humans. Recent studies using fear conditioning in human subjects have also reported the emergence of prefrontal slow oscillations between 2-6 Hz during expression of conditioned fear responses. These results suggests that common mechanisms underlie the expression of fear in humans and rodents. However, whether similar neuronal circuits and mechanisms are implicated in human anxiety disorders remains unknown.
This study aims at assessing the presence of slow mPFC oscillations during expression of anxiety in patients suffering from anxiety disorders. Beyond understanding of the neuronal mechanisms underlying anxiety expression, this study could provide a biomarker of anxiety with diagnostic and therapeutic implications.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- First phase (go-no-go) with 10 subjects in 1 arm Second phase with 20 subjets (2 arms) in a cross-over design.
| Arm | Type | Receives |
|---|---|---|
| Group 1: Go-no-go phase | Experimental | Behavioral: In vivo social exposure, Other: EEG recording, Diagnostic Test: Psychometric evaluation, Diagnostic Test: Visual Analogue Scale of anxietyThe 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. |
| Group 2.1 | Experimental | 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 anxietyIn 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. |
| Group 2.2 | Experimental | 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 anxietyIn 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In vivo social exposureSubjects 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. | Behavioural | Group 1: Go-no-go phase, Group 2.1, Group 2.2 |
| Social exposure in a virtual reality settingSubjects 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. | Behavioural | Group 2.1, Group 2.2 |
| EEG recordingEEG 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 | Other | Group 1: Go-no-go phase, Group 2.1, Group 2.2 |
| Psychometric evaluationSubjects 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) | Diagnostic test | Group 1: Go-no-go phase, Group 2.1, Group 2.2 |
| Visual Analogue Scale of anxietySubjects will be asked to rate their anxiety levels * immediately before (5 minutes of silent waiting), * during * and after the 5-minute oral presentation (recovery) | Diagnostic test | Group 1: Go-no-go phase, Group 2.1, Group 2.2 |
Primary outcome
Change in power of slow oscillations in prefrontal EEG recordings during anticipation relative to baseline
Time frame: During the 5 minutes before oral presentation and during the 1 hour rest period
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.
1 secondary outcome
Duration of prefrontal slow oscillations epochs during anticipation
Time frame: During the 5 minutes before oral presentation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Doumy, MD principal investigator
Centre Hospitalier Charles Perrens, Bordeaux; INRA NutriNeuro, Bordeaux; Université de Bordeaux, France
Alexandra Bouvard, MD principal investigator
Centre Hospitalier Charles Perrens, Bordeaux; Université de Bordeaux, France
Cyril Herry, PhD study director
Neurocentre Magendie, Inserm U1215, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In vivo social exposure, Social exposure in a virtual reality setting and EEG recording in people with Anxiety Disorders and Anxiety, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site 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 4 inclusion and 13 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Change in power of slow oscillations in prefrontal EEG recordings during anticipation relative to baseline (time frame: During the 5 minutes before oral presentation and during the 1 hour rest period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Jul 2026.