NCT05966610

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 30, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 12, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

12 months

First QC Date

May 30, 2023

Last Update Submit

July 25, 2023

Conditions

Keywords

Praecox FeelingSelf-DisordersSubjectivityCognition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Correlation between Praecox Feeling and symptomatic dimensions

    2 months

  • Correlation between Praecox Feeling intensity and Self Disorders intensity

    2 months

  • Correlation between the patient's judgment and the quality of the meeting

    2 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Stabilised patients with schizophrenia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Tudi GOZE, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2023

First Posted

July 28, 2023

Study Start

July 12, 2023

Primary Completion

July 1, 2024

Study Completion

September 1, 2024

Last Updated

July 28, 2023

Record last verified: 2023-07

Locations