Bizarreness and Anomalous Self Experiences in Schizophrenia

Schizophrenia Clinical Trial

— BASES  

Official title:

Bizarreness and Anomalous Self Experiences in Schizophrenia: Pilot Study on Diagnostic Decision-Making

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05966610
• Other study ID #: RC31/22/0517
• Secondary ID: 2023-A00049-36
• Status: Recruiting
• Start date: July 12, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: July 2023
• Source: University Hospital, Toulouse
• Contact: Tudi GOZE, MD
• Phone: 5 61 77 23 60
• Email: goze.t[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: September 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 months
Secondary	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	2 months
Secondary	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.	2 months
Secondary	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.	2 months