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Future Mental Projections in Schizophrenia (FutureProSchiz)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03040505
Recruitment Status : Recruiting
First Posted : February 2, 2017
Last Update Posted : August 20, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
The aim of the study is to investigate temporal organization of future thinking in patients with schizophrenia. Patients and control participants will be asked to envision and briefly describe ten personal future events using a cue-words list. Then they will be asked to describe everything that came to their minds (i.e. to think aloud) while they attempted to determine when an event will likely occur. The investigators will compare the proportion of several predefined strategies mentioned by the two groups of participants to locate future events in time. The investigators predict that patients will envision less personal future events and will rely to a lesser extent on strategies to locate events in time, than control participants.

Condition or disease Intervention/treatment
Schizophrenia Other: questionnary

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Future Mental Projections in Schizophrenia
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients with schizophrenia
Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria
 Other: questionnary
Participant's verbalization will be audio recorded and then transcribed by investigators. The investigators will use predefined categories to score the strategies mentioned by participants during the think aloud task.
Control participants
- Control participants without psychiatric nor neurological history
 Other: questionnary
Participant's verbalization will be audio recorded and then transcribed by investigators. The investigators will use predefined categories to score the strategies mentioned by participants during the think aloud task.


Outcome Measures
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Primary Outcome Measures :
  1. Number of time location strategies [ Time Frame: 1 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with Schizophrenia
Criteria

Inclusion Criteria:

  • for patients only
  • male or female
  • age limits : 18-55 years old
  • under the protection of health insurance
  • who have signed up the consent form
  • schizophrenia or schizo-affective disorder according to the DSM-5 criteria (APA, 2013).
  • clinically stable for at least 2 months
  • patients under guardianship or curatorship need agreement of their legal representative
  • informed of the results of prior medical examination for controls only
  • male or female
  • age limits : 18-55 years old
  • under the protection of health insurance
  • who have sign up the consent form
  • recruited from the general population and matched on gender, age years of schooling
  • no psychiatric history (DSM-5)

Exclusion Criteria:

  • for both patients and controls
  • current severe or unstable somatic illness
  • neurological history (brain injury > 15 minutes loss of consciousness , epilepsia, brain surgery…)
  • current substance use disorder (DSM-5)
  • current major depressive disorder (CDSS,BDI, HDRS)
  • mental retardation (IQ < 70, WAIS-4, f-NART)
  • history of general anesthesia 3 months prior to the experiment
  • pregnancy declared by the subject
  • breast feeding
  • current legal control
  • in emergency situation
  • included during exclusion period in another experiment
  • for controls only
  • taking of antipsychotic drugs for the 3 weeks prior to inclusion
  • under guardianship or curatorship
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03040505


Contacts
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Contact: Fabrice BERNA, MD 0033388116462 fabrice.berna@chru-strasbourg.fr

Locations
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France
Service de psychiatrie 1 Recruiting
Strasbourg, France, 67000
Contact: Fabrice Berna         
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT03040505    
Other Study ID Numbers: 6527
First Posted: February 2, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders