SchizophreniaBASESNCT05966610
Bizarreness and Anomalous Self Experiences in Schizophrenia
An observational study of Schizophrenia, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia. However, determining factors of this phenomena, whether cognitive or subjective, remains poorly studied. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 12 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jul 2023to 6 Sep 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stabilised patients with schizophrenia
Who may be able to join
- People with a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
- Psychiatric medical situation judged clinically stable : no change of main antipsychotic in treatment in last 15 days.
- People who has given his non-opposition
- Patients affiliated to a social security system
Who cannot join
- Previous meeting of the participant with one of the investigators involved in the clinical assessment and scoring of the study scales.
- Person with a moderate to severe intellectual disability (clinical criteria).
- Person with a neurological pathology with cognitive impact
- Patients with legal protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bizarreness and Anomalous Self Experiences in Schizophrenia: Pilot Study on Diagnostic Decision-Making
Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia.
However, determining factors of this phenomena, whether cognitive or subjective, remains poorly studied.
Furthermore, Self-Disorders are alterations of the first-person experience regarded as specific of the disease. The investigators plan to study in an exploratory way the phenomenological and subjective links between Praecox Feeling and Self Disorders determinants, while hypothesizing that the clinician's Praecox Feeling can be positively correlated to SDs, as our main objective.
Read the detailed description
Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia. However, subjective, cognitive or neurophysiologic aspects of this phenomena remains poorly studied.
Furthermore, Self-Disorders (SD) are alterations of the first-person experience and of sense of agency, regarded as specific of Schizophrenia. Unlike Praecox Feeling, clinical, cognitive and neuropsychological determinants of SD are increasingly studied.
The investigators plan to study in an exploratory way the links between Praecox Feeling and SDs determinants, while hypothesizing that the clinician's Praecox Feeling can be positively correlated to SDs, as our main objective.
As a secondary outcome, the investigators will control this correlation by a comparison between SDs evaluation and clinician subjectivity.
The present study also plan to evaluate the associations between Praecox Feeling and clinical features, low and high cognitive level with attentional and social cognition evaluations.
The first step of the research project is to implement this exploratory design in a transversal multicentric setting between centers with a limited number of participants and without follow-up.
- Conditions
- Schizophrenia
- Keywords
- Praecox Feeling, Self-Disorders, Subjectivity, Cognition
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between Praecox Feeling and Self Disorders
Comparison between Examination of Anomalous Subjective Experience (EASE) total score evaluated at third visit and mean of Praecox Feeling intensity measured by a visual analog scale (VAS) evaluated at each visit.
Examination of Anomalous Subjective Experience is a 5-item interview asked by the investigator.
Visual Analog Scale (VAS) is a scale that evaluates the level of strangeness felt during the patient/investigator encounter. It goes from 0 (no strangeness feeling) to 100 (maximal strangeness feeling).
Measured: 2 months
Secondary outcomes (3)
Correlation between Praecox Feeling and symptomatic dimensions
Comparison between mean of Praecox Feeling intensity measured by a visual analog scale evaluated at each visit and Cognition evaluation in second visit with attentional evaluation (D2-R and results at Go/No-Go testing) and social cognition evaluation (TOM-15).
D2-R is a paper-and-pencil test. It's consists of the subject identifying and crossing out target characters (d with 2 lines) from a large number of characters.
Go/No-Go testing is a test assesses behavioural control in a test where the participant must be able to respond to an automated external stimulus.
TOM-15 consists of a false belief task and a comprehension task using the same 15 stories but different questions. The stories proposed show everyday situations. There are 8 first-order questions and 7 second-order questions, allowing two scores to be calculated, one for each order (maximum 15 in total). The more correct answers, the higher the score
Measured: 2 months
Correlation between Praecox Feeling intensity and Self Disorders intensity
Comparison between Examination of Anomalous Subjective Experience (EASE) total score a the third visit and mean of clinician subjectivity measured by Assessment of clinician's subjective experience (ACSE) at each visit.
Examination of Anomalous Subjective Experience is a scale completed during the clinical interview by the investigator. It consists a 5-item scale.
Assessment of clinician's subjective experience is a scale completed during the clinical interview by the investigator. It is composed of 45 items.
Measured: 2 months
Correlation between the patient's judgment and the quality of the meeting
Meeting Quality, according to the participant, evaluated at second visit in an unstructured way.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start12 Jul 2023
- Primary completion6 Jun 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tudi GOZE, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966610
- Sponsor's protocol ID
- RC31/22/0517
- Other IDs
- 2023-A00049-36
- Acronym
- BASES
- Status last verified
- Oct 2026
- First submitted
- 30 May 2023
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bizarreness and Anomalous Self Experiences in Schizophrenia: Pilot Study on Diagnostic Decision-Making
- ClinicalTrials.gov ID
- NCT05966610
- Acronym / sponsor ID
- BASES / RC31/22/0517
- Conditions
- Schizophrenia
- Keywords
- Praecox Feeling, Self-Disorders, Subjectivity, Cognition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 6 Jun 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 28 Jul 2023 (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.
Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia.
However, determining factors of this phenomena, whether cognitive or subjective, remains poorly studied.
Furthermore, Self-Disorders are alterations of the first-person experience regarded as specific of the disease. The investigators plan to study in an exploratory way the phenomenological and subjective links between Praecox Feeling and Self Disorders determinants, while hypothesizing that the clinician's Praecox Feeling can be positively correlated to SDs, as our main objective.
Detailed description
Several authors suggest that the specific experience felt in clinical encounter, called Praecox Feeling, is directly linked to the psychopathology of Schizophrenia. However, subjective, cognitive or neurophysiologic aspects of this phenomena remains poorly studied.
Furthermore, Self-Disorders (SD) are alterations of the first-person experience and of sense of agency, regarded as specific of Schizophrenia. Unlike Praecox Feeling, clinical, cognitive and neuropsychological determinants of SD are increasingly studied.
The investigators plan to study in an exploratory way the links between Praecox Feeling and SDs determinants, while hypothesizing that the clinician's Praecox Feeling can be positively correlated to SDs, as our main objective.
As a secondary outcome, the investigators will control this correlation by a comparison between SDs evaluation and clinician subjectivity.
The present study also plan to evaluate the associations between Praecox Feeling and clinical features, low and high cognitive level with attentional and social cognition evaluations.
The first step of the research project is to implement this exploratory design in a transversal multicentric setting between centers with a limited number of participants and without follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stabilised patients with schizophrenia
Key inclusion criteria (4 listed)
- People with a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria.
- Psychiatric medical situation judged clinically stable : no change of main antipsychotic in treatment in last 15 days.
- People who has given his non-opposition
- Patients affiliated to a social security system
Key exclusion criteria (4 listed)
- Previous meeting of the participant with one of the investigators involved in the clinical assessment and scoring of the study scales.
- Person with a moderate to severe intellectual disability (clinical criteria).
- Person with a neurological pathology with cognitive impact
- Patients with legal protection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between Praecox Feeling and Self Disorders
Time frame: 2 months
Comparison between Examination of Anomalous Subjective Experience (EASE) total score evaluated at third visit and mean of Praecox Feeling intensity measured by a visual analog scale (VAS) evaluated at each visit. Examination of Anomalous Subjective Experience is a 5-item interview asked by the investigator. Visual Analog Scale (VAS) is a scale that evaluates the level of strangeness felt during the patient/investigator encounter. It goes from 0 (no strangeness feeling) to 100 (maximal strangeness feeling).
3 secondary outcomes
Correlation between Praecox Feeling and symptomatic dimensions
Time frame: 2 months
Correlation between Praecox Feeling intensity and Self Disorders intensity
Time frame: 2 months
Correlation between the patient's judgment and the quality of the meeting
Time frame: 2 months
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 23 Oct 2026.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Tudi GOZE, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by University Hospital, Toulouse 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 4 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 23 Oct 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?
Correlation between Praecox Feeling and Self Disorders (time frame: 2 months). 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 23 Oct 2026.